Pharmaceutical Law

Original Language Title: Lääkelaki

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Read the untranslated law here: http://www.finlex.fi/fi/laki/ajantasa/1987/19870395

In accordance with the decision of the Board of the General provisions of the Act provides that the purpose of Chapter 1, section 1, (31 January 2003/80) the purpose of this Act is to maintain and promote the use of medicinal products and their safety as well as the appropriate use of medicines. The purpose of the Act is to ensure the availability of appropriate manufacturing of medicinal products and in the country.

Scope of application of article 2 of this law relates to medicines, their manufacture, import, distribution, sale and consumption of the transmission and the transfer of the above in the pharmaceutical factories, medicine wholesale shops and pharmacies, medicinal products, medicinal products in pre-clinical safety laboratories, as well as the manufacture of pharmaceutical products and the distribution of hospitals and health centres. (30.12.2013/1200)
In addition, the law provides for the registration of the product and of the activities referred to in subparagraph (1) above, the control on the other. (as of 4 November 2005/853)
The provisions of this Act shall not apply to products that are used solely for aquarium fish, parasitic, fungal or bacterial diseases and not just as pets or animals of birds, terrarium pikkujyrsijöiden vitamin formulations. Article 22 (a) to the homeopathic preparations referred to in article 55 (1) shall not apply to the article. (as of 4 November 2005/853)
This law, the granting of a marketing authorisation, amendment of the marketing authorisation of a medicinal product-related fees, the marketing authorisation of a medicinal product for consumption, a ban on the transfer of the withdrawal and shall not apply to medicinal products with a marketing authorisation and the rest of the controls decided by the European Medicines Agency or the Commission of the European communities or the Council of the European Union (an institution of the European Union) in the acts of the European Community, as it provides for. If the protection of human or animal health or the environment, it urgently requires the development of security and in the pharmaceutical sector, it may temporarily prohibit the extradition of a proprietary medicinal product for consumption, until an institution of the European Union has resolved the matter. In the control of proprietary medicinal products referred to in paragraph kauppaantuontiin and the related charges can be adjusted by the Ministry of Social Affairs and health. The amount of the fee is determined by the law of the State, what the basis of payment (150/1992). Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions in the control of the person responsible for marketing of pharmaceutical products and referred to in the paragraph, in so far as there is no provision for the powers of the European Community or does not have been arrested in the institutions of the European Union. (2009/773)

The definitions in section 3 (as of 4 November 2005/853) medicinal product shall mean a product, or a substance which, if used to internally or externally to cure, relieve or prevent a disease or its symptoms in humans or animals.
As a medicinal product shall also be considered as a substance or substances used internally or externally, the combination of which can be used for human or animal, restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical condition or illness.
In cases of doubt, where, taking into account all its characteristics, a product may respond to the drug and the rest of the provisions of the legislation or of the European Union, the definition of the product, shall apply to the product in the first place, what the drug is provided.

3. (a) section (30.12.2013/1200) väärennöksellä means any medicinal product which, for a reason other than the accidental quality as a result of this error will be presented: 1) one of the drug's identity, which are: (a) the characteristics of the label and packaging);
(b)), the name of the medicinal product;
(c) the composition of the medicinal product, including all the ingredients) and other ingredients, which are not drugs and packaging materials;
the strength of an ingredient of the medicinal product (d));
the origin of the medicinal product, the manufacturer 2), country of origin, the country of origin or the holder of the marketing authorisation; or 3) of the medicinal product, including the product distribution channels used in the history-related materials and documents.

section 4 of the proprietary medicinal product shall mean any medicinal product: 1) which have been manufactured or imported in accordance with this law; and 2) which is intended for use as a medicinal product; as well as 3) which is sold for consumption, are supplied in the sales package or otherwise.
(26.11.1993/1046) Medicine meets the criteria, it is considered also the plasma of human origin, which is prepared by a method involving an industrial process. (as of 4 November 2005/853), section 5 of the drug is chemically or otherwise, scientific methods in detail defined in the body to the active ingredient in the manufacture of the medicinal product, which is used or to be a medicinal product as such.

(5) (a) section (as of 4 November 2005/853) traditional herbal medicinal product shall mean any medicinal product which contains the meaning of humans as active ingredients one or more herbal substances, herbal preparations, or one or more of the combinations and which meet the conditions applicable to the registration provided for in subparagraph (1). A traditional herbal medicinal product may also contain vitamins or minerals, if they contribute to the effect of the active substances of plant origin.

section 5 (b) (as of 4 November 2005/853) Homeopathic preparation means a proprietary medicinal product, which is made out of stocks by the European Pharmacopoeia or, failing this, in the Member States used officially in the Member States. in accordance with a homeopathic manufacturing procedure described in. The homeopathic preparation can be made more homeopathic.
The provisions on homeopathic medicinal products shall also apply to other products, which are made in accordance with paragraph 1 of the homeopathic methods.

section 5 (c) (as of 4 November 2005/853) product means a medicinal product which has been granted marketing authorisation in accordance with article 21 or a country of the European economic area, is granted by the Community code relating to veterinary medicinal products of the European Parliament and of the Council amending Directive 2001/82/EC, hereinafter referred to as the directive on veterinary medicinal products, or of article 5 of the Community code relating to medicinal products for human use of the European Parliament and of the Council amending Directive 2001/83/EC, hereinafter referred to as the medicine directive, pursuant to article 8 of the marketing authorisation or for which the European Union has granted the marketing authorisation. (10.12.2010/1112)
Rinnakkaisvalmisteella shall mean a medicinal product which is the qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference product has been demonstrated by appropriate bioavailability studies. The active substance of different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives are considered the same active ingredient, unless their safety or efficacy characteristics differ in a significant way. The applicant for marketing authorisation shall provide any further information on the active substance of different salts, esters or derivatives of safety or efficacy. A variety of drug, administered orally, immediately opt-outs in pharmaceutical forms shall be considered the same pharmaceutical form. Bioavailability studies need not be conducted if the applicant for marketing authorisation for a generic product comply with the relevant European Union shows the Commission adopt detailed criteria as defined in the instructions.

Article 5 (d) (as of 4 November 2005/853) Lääkkeellisellä gas means a gas or gas mixture, the use of which is based on the pharmacological activity of the effect, which is intended to be administered to the patient hoidolliseen, diagnostic or preventive purpose and which has been manufactured and checked in accordance with the good manufacturing practice for medicinal products.

Article 5 (e) (30.12.2013/1200) the Agent means any medicinal ingredients that are not pharmaceutical substances and packaging materials.

section 6 (2009/773) in the pharmaceutical sector for the development of the Centre is responsible for the security and, where appropriate, to decide whether or not a substance or preparation to be considered to be a medicinal product, a traditional kasvirohdosvalmisteena or homeopaattisena product.

Other laws 7 section (2009/773) for the purposes of this Act, the Narcotic Drugs Act (373/2008) are also drugs, shall be valid for a period, in addition to what are provided for in the said law.
In addition to the provisions of this law on medicinal products, the European Community provided for by the law on alcohol, medicines (1143/1994) and under it.
The obligation for the storage of medicinal products lays down the obligation for the storage of the medicinal products Act (979/2008).
If a product as referred to in this Act must be regarded as waste within the meaning of the Act (646/2011) of the hazardous waste, it is subject to what is provided for in the said Act or any of its hazardous waste under or provided for. (17 June 2011/662) Chapter 2 section 8 of the manufacture of medicinal products medicinal products can be manufactured by the industrial manufacturing of industrial application only the safety of the pharmaceutical sector-and with the permission of the Centre for the development of the pharmaceutical factory, which is acceptable in production facilities and equipment. Conditions may be attached to the authorisation. (2009/773)
The information to be forwarded by the time of the application for authorization and the subject of more specific State by means of a Council regulation. The State Council regulation also lays down the time within which an application for authorisation will have to be resolved. (a/700)
Centre for the development of safety in the pharmaceutical sector and is responsible for the authorization to export to the European Medicines Agency to maintain data related to the database. (30.12.2013/1200)


section 9 (30.12.2013/1200) the medicine factory is to be employed by them in direct employment by the responsible manager, which primarily is responsible for ensuring that they meet the pharmaceutical plant produced by those in the law or the requirements set out under it and that they are unimpaired, as well as for the industrial manufacture of the medicinal products are complied with and the quality of the monitoring of the manufacture of pharmaceutical products for the provisions of this Act and the provisions of the provisions adopted in the implementation of and.
The Director shall be the responsibility of the pharmaceutical factory, a licensed pharmacist or other appropriate degree completed. About the responsibility of the Director is required in addition to that he has worked for an appropriate period in the pharmaceutical factory in the manufacture of medicinal products or quality assurance. The responsible manager must not be at the same time under the responsibility of the Director of another company, which has been given permission to industrially manufacture medicinal products. The responsible manager shall not be subject to the liability of a Director of another company's pharmaceutical wholesale and pharmacies, hospital, pharmacy or medical center nurse, the Director of the military pharmacy or a pharmacy or a pharmacy attendant. page The responsibility of the Director's qualifications may be used, where appropriate, to provide more detail on the Government's regulation.
Unless the responsible manager fill in the certificate referred to in paragraph 2, in addition to the requirements of article 53 of the directive on veterinary medicinal products or medical eligibility criteria laid down in article 49 of the directive, the pharmaceutical products will be amplified by the holder of the authorization shall be in whole or in part under the direct staff employed with the company for at least one qualified person provided for in those directives. Qualified person is responsible for ensuring that the medicinal product-items are made of the marketing authorisation and in accordance with good manufacturing practice. Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on the tasks of the qualified person.
Government regulation is necessary in order to provide for exceptions to the quality of medicinal products provided for in paragraph 2 and 3 of the control and the responsibility of the Director of the laboratory and the qualified person's qualifications.

section 10 (opening/1112) Pharmaceutical Factory can be technical, economic or productive as necessary for the manufacture of proprietary medicinal products, to have the matters (contract manufacturing) or control (analysis) in whole or in part on another medicine factory (contract manufacturers) or plant (sopimusanalysoija).
The agreement with the manufacturer and the liberalisation of the medicinal drug or analyses the current sopimusanalysoijalla will need to have the authorization referred to in article 8 for the industrial manufacture of medicinal products. Sopimusanalysoijan contract and shall inform the establishment of security and development in the pharmaceutical sector to the Agency at least 60 days before the commencement of such activity. The notification shall be accompanied by a copy of the factory and for the conclusion of an agreement between the contract or sopimusanalysoijan.
Centre for the development of the pharmaceutical sector, security and the provisions of the contract and the contract may provide for the analysis of procedures to be followed.

section 11 (a/700) the medicine plant must comply with the good manufacturing practice for medicinal products, which are in conformity with the principles and guidelines which have been approved in accordance with article 47 of the pharmaceutical directive. In the manufacture of proprietary medicinal products may be used only to active substances which have been manufactured and distributed in accordance with pharmaceutical good manufacturing and distribution in accordance with the instructions of the European Union. Medicine factory is to ensure that we are manufacturers, importers and distributors, from whom they get people registered for the medicinal products referred to in myyntiluvallisten or used in the manufacture of medicinal products, are registered with the competent authority of the Member State of the European Union, in which they are established. Medicine factory is by making evaluation visits were carried out at drug manufacturing and distribution locations to ensure that pharmaceutical manufacturers and distributors to comply with good manufacturing practice and good distribution practices. Medicine factory has to make such checks itself or authorize a third party, they have to make. This authorisation shall be without prejudice to the responsibility of the pharmaceutical factory in accordance with the law. Myyntiluvallisten or registered medicinal products for human use, the manufacturer shall specify the demands made on the manufacture of excipients in the medicinal products with appropriate good manufacturing practices and ensure that they are implemented. In the pharmaceutical sector for the development of security and can give more specific provisions on drugs and excipients for good production and distribution methods. (30.12.2013/1200)
Medicine factory shall keep a list of drugs for sale. The list shall be kept for at least five years. A list of contents and storage can be adjusted more precisely the State Council regulation.
Pharmaceutical manufacturer shall be notified to the Agency for security and development in the pharmaceutical sector and the holder of the marketing authorisation or registration immediately if it becomes aware that the market has to be, or suspected of being counterfeit medicines the medicinal products covered by the pharmaceutical factory, the manufacturing authorization, regardless of whether the medicines distributed legally or illegally. (30.12.2013/1200)

Other than the manufacturing section 12 (opening/1112) as a pharmacist, and the page as a pharmacist must not only to proprietary medicinal products manufactured by a pharmacy or a pharmacy, as well as service point to the page of their own for the purpose of sale.
Pharmacies may, however, the second individual medicinal products manufactured in a pharmacy and buy individual article 17 in accordance with the first subparagraph of paragraph 3, the imported raw materials for the manufacture of its own. Apothecary is to make this announcement to the security and development of the pharmaceutical sector. The provisions of the pharmacy in the manufacture of medicinal products, the Centre may provide and the contract, as well as the procedures for the preparation of more specific provisions on the notification procedure.

Article 12 (a) (10.12.2010/1112) Pharmacy and hospital pharmacy dose distribution and contract manufacturing of mechanical medical centre for the development of the field of security and authorization. The authorisation shall be granted if the action meets the requirements laid down in article 15. I promise can be attached to the transfer and use of the medicinal product manufacture, as well as other conditions required for drug safety.
Pharmacies must contract the second dose on the basis of the distribution agreement and forced air dose distribution of the licensed pharmacy.

section 13 (2009/773) a pharmacy, pharmacist, hospital pharmacy and the military medical center will make the safety of the pharmaceutical sector and the development of advance notification of its own medicines.

section 14 (a/700) the hospital pharmacy or Medicine Center will manufacture the medicinal hospital, hospital or health centre, their own and 62 of the activities referred to in paragraph (3) to the extent necessary. The manufacture of medicinal products must comply with the good manufacturing practice for medicinal products, which are in conformity with the principles and guidelines for the provisions of the European communities, which have been approved and the approval for the production of pharmaceutical products in the context of the Protocol annexed to the Convention on mutual inspections.
Hospital pharmacy may carry out the manufacture of the medicinal product, as referred to in subparagraph (1) or the second reconstitution of the hospital pharmacy where a manufacturing requires a special category spaces. In addition, the hospital pharmacy may carry out a reconstitution of the radioactive medicinal products in the European economic area, this hotel features a medicine factory in the manufacture. The contract will cover the authorisation agreement recognised. Drugs for sopimusvalmistuttavan hospital pharmacy manager shall be sopimusvalmistuttamisesta notification to the security and development of the pharmaceutical sector. The Centre may issue regulations on the procedures, the hospital pharmacy and medicine centre must comply with the drugs manufacture and hospital pharmacy must comply with the provisions of the Declaration, as well as more detailed procedure for medicinal products valmistuttaessaan. (30.12.2013/1200) section 15 (opening/1112), pharmacies, hospital pharmacies, page-pharmacies and medical centres for the manufacture of medicinal products and power dose distribution is subject to the condition that the staff are adequately familiar with the manufacture of medicinal products and that the necessary means of production facilities and the equipment are appropriate. This should be done in addition to follow, mutatis mutandis, in accordance with article 11 of the good manufacturing practice of medicinal products.
More detailed provisions on the conditions of a permit may be issued by the State Council. In the pharmaceutical sector for the development of security and can not issue orders under section 12 (a), in accordance with the provisions to apply.

15 (a) in the section (2009/773) for Clinical studies be used in the preparation of drugs for pharmaceutical safety and with the permission of the Centre for the development of. I promise can be attached to the transfer and use of the medicinal product manufacture, as well as other conditions required for drug safety.
In addition to the provided for in paragraph 1, the clinical medical trials for medicinal products referred to in article 8 may be manufactured by licence holders, as well as articles 12 and 14 of the manufacturers in accordance with the provisions referred to in this law and under it and provides it. The pharmaceutical manufacturers must submit a notification to the security and development of the pharmaceutical industry in clinical medicine in the study of the preparation before the start of manufacture, the use of the medicinal product. (30.12.2013/1200)

Clinical investigation of medicinal products used in the manufacture of which is to be followed, mutatis mutandis, to the preparation of this law, what medicines, or under it.
In the pharmaceutical sector for the development of security and can give more detailed provisions on clinical drug trials in the manufacture of medicinal products, the authorization referred to in subparagraph (1), how to apply, and the notification referred to in paragraph 2.

Article 15 (b) (23.4.2004/296) medications for clinical medicine studies the total unit must be employed for at least one of good clinical practice in the conduct of clinical trials on medicinal products for human use in the Member States ' laws, regulations and administrative provisions of the European Parliament and of the Council on the approximation of the provisions of Directive 2001/20/EC, article 13 of the qualified person referred to in paragraph 2. In the pharmaceutical sector for the development of security and provide more detailed provisions on the tasks of this person. If the unit is in the pharmaceutical manufacturing operations on a large scale, the unit will be under the responsibility of the Director, who shall exercise the tasks and conditions are determined in accordance with section 9. (2009/773)
Medications for clinical medicine studies for the manufacturing of the unit may have a clinical medicine research for contract manufacturing under the conditions provided for in article 10.
Drugs in clinical trials in the pharmaceutical manufacturing unit must comply with article 11 of the studies: good manufacturing practice for medicinal products as laid down in.

15 (c) of section (2009/773) advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 1782/2003 Regulation (EC) No 726/2004 of the European Parliament and of the Council amending Regulation (EC) No 1782/2003 1394/2007 on advanced therapy medicinal products referred to in the non-industrial manufacturing requires the development of pharmaceutical security and authorization. The authorization shall be granted for the manufacture of medicinal products on medical prescription for an individual patient's Hospital for individual treatment. I promise I'll be connected to manufacturing, supply, traceability and on the use of the necessary conditions of drug safety. Permission may be given in a temporary or indefinite period of time.
In the manufacture of advanced therapy medicinal products that use is to be followed, mutatis mutandis, to the manufacture of medicinal products, what this law or under it.
Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on applying for the authorization referred to in paragraph 1 and the contents of the application, advanced therapy medicinal products, other than on the quality of the conditions and preparations for the industrial manufacture of traceability and pharmacovigilance.

section 16 (16 October 2009/773) in the pharmaceutical sector for the development of security and provide more detailed provisions for the prior notification referred to in article 13, as well as 12 and section 14 of the regulations of the European communities, under and on the approval for the production of pharmaceutical products based on medicinal products, the Protocol to the Convention on mutual inspections. In the pharmaceutical sector for the development of security and can give more specific provisions on the labelling of medicinal products manufactured within the sales.
Chapter 3 relief from section 17 of the medicinal products (as of 4 November 2005/853) drugs to be imported: 1), which may be an industrially manufactured drugs from pharmaceutical factory;
2) it according to article 32, which is authorized to engage in wholesale trade;
3) pharmacies, pharmacy of the University of Helsinki, University of Kuopio Pharmacy and pharmacy operations and article 12 of the Military pharmacy of the activities referred to in paragraph 2;
4) hospital-pharmacy in individual cases, the relevant hospital, hospital or health centre and 62 of the activities referred to in paragraph (3);
5 University of University of technology and scientific research), Department of research activity; In addition to clinical medicine research as well as 6), which has the right to make additional copies of the medicines in clinical medicine research.
The hospital pharmacy, University, University and scientific research body must carry out the import notification for security and development in the pharmaceutical sector. (2009/773)
If the myyntiluvallinen or registered with the medicine or clinical studies for medicinal products medicinal products are imported into the country outside the European economic area, in accordance with section 8 of the importer to be authorized to supply medicinal products to the industrial production. The above mentioned pharmaceutical products, the importer shall ensure that the countries outside of the European economic area and the imported medicinal products have been carried out in Finland or in another country of the European economic area, in accordance with the requirements of the marketing authorisation for the medicinal product quality assurance inspection. From countries outside the European economic area, the quality of the imported medicinal products run on the audit of the Government by means of a Council regulation. (30.12.2013/1200)
Other than the first sentence of section 1 – the trader referred to in paragraph 3 can import medicinal substances for the production activities. This imports the trader shall be notified to the security and development of the pharmaceutical sector. (2009/773)
Centre for the development of security and in the pharmaceutical sector and customs allowed to import medicines that are necessary in order to carry out the tasks provided for in this law for the control. The Centre for security and development in the pharmaceutical sector or customs office does not require a permit issued in accordance with paragraph 3. (30.12.2013/1200) 17 (a) of section (30.12.2013/1200) for the manufacture of medicinal products for human use myyntiluvallisten or use of registered drugs may be imported from outside the European Union or the European economic area only if the following conditions are met: 1) have been complied with in the manufacture of pharmaceutical substances requirements which are at least equivalent to those laid down in the European Union in accordance with the requirements of good manufacturing practice;
2) medicine accompanied by the exporting third country with a written confirmation issued by a competent authority, that: (a) an establishment for the manufacture of pharmaceutical products for export to the country) will be subject to requirements which are at least equivalent to the medicine in accordance with the third paragraph of article 47 of the directive laid down in the good manufacturing practice requirements of the European Union;
(b)) the manufacturing plant is part of a rigorous and transparent control of the regular and recurring checks and without prior notice, or any other similar method of effective production control measures, in order to ensure, at least similar charge structure for the protection of public health as in the European Union;
(c)) the exporting the information provided by the third country without delay, any failure to comply with the requirements established in the Union.
The requirements referred to in this article shall not apply if the exporting country is the medicine of the Commission referred to in article 111 (b) of the directive in the list maintained by the.
If any Member State of the European Union or the European economic area has been checked by the manufacturing plant and the export of the active substance is found it to comply with the directive on medicinal products in accordance with article 47 established the principles and guidelines of good manufacturing practice, Medicine in the field of security and development, the Centre may, if it considers it necessary for reasons of ensuring the availability of medicinal products of exception, grant an exemption from the requirements referred to in this article does not exceed the period of validity of the certificate of good manufacturing practice. Centre for the development of the pharmaceutical sector in the security and the granting of the exemption shall be notified to the European Commission.
Centre for the development of safety in the pharmaceutical sector and the provisions of paragraph 1 may, where necessary, lay down more detailed purpose of drug imports.

18 section (a/700) the list of Imported drugs and section 17 of the notification referred to in paragraph 2, provided for the Council of State regulation of the importation.

section 19 (13 January 2006/22) an individual may be imported to Finland for personal lääkitystään pharmaceutical preparations, which have been obtained from the supplier of the product vähittäisjakeluun to be legitimate. The import of drugs is not permitted. The purchase of a medicinal product should be based on the imposition of a medicinal product in the prescription of the person entitled to give the medicine. In addition, from abroad to Finland in the future a person may bring with them at the same time the effects of an animal imported for the treatment of the necessary medicines for up to one month of the need for a similar amount.
Elsewhere than in Finland permanently resident medical or veterinary profession to the person entitled to it may be the time to bring with them and use the marketing authorisation of the medicinal product, which is in the country, where he mainly engaged in the profession in the country of arrival and, if the need for proprietary medicinal products is based on the value of sport in Finland temporarily, the international competition or to a person entitled to the rest of the group or of the person involved in the transaction or the animal or group of medical need. However, the import does not apply to criminal justice (39/1889), Chapter 44, section 16 referred to as doping agents. The imported drug products may be used only by those who imported them leaves the responsibility of the medical care of persons, or under the responsibility of a veterinarian to treat the animal.
If the permanent resident in Finland, a licensed physician, dentist or veterinarian has exported drugs in Finland, persons usually resident in the animal or a temporary stay abroad early drug treatments to insure against, may he bring back the unused drug products in Finland.

The State Council regulation can be adjusted in 1 – 3 the import conditions referred to in subsection, as well as restrictions with regard to the acquisition of the land of the medicinal product to be imported, the method of acquisition of the medicinal product, as referred to in paragraph 2, the quality of the competition or the rest of the event and the maximum amount of a medicinal product to be imported to the country. The Council of State regulation may also prohibit or restrict the importation of narcotic drugs in accordance with the law of substances containing scheduled substances for medicines. The requirement of prior notification of imports may also instruct the authority or person to make a temporary stay in the event the Organizer on the basis laid down in the regulation of the Council of State. Regulation of the Council of State can also be used to restrict the importation of veterinary, if they may jeopardize the safety or quality of food of animal origin, or if they may result in more significant harm to animals, humans or the environment, or they may endanger Finnish resistance to the diseases in animals.
Chapter 4 (as of 4 November 2005/853), the scope of the authorisation and the Registration Number (as of 4 November 2005/853) section 20 (as of 4 November 2005/853), the provisions of this chapter shall apply to medicinal products and lääkkeellisiin gas, which is produced or imported.

20 (a) in the section (2009/773) product to the population or any other release for consumption requires that the safety of the pharmaceutical sector-and Development Center has issued a product licence or registered in accordance with the law, or that the this is a marketing authorisation granted by the institution of the European Union.

The marketing authorisation (as of 4 November 2005/853) section 21 (as of 4 November 2005/853) safety in the pharmaceutical sector and the development of the grant of the marketing authorisation for medicinal products for human use and veterinary medicinal products other than laying down Community procedures for the authorisation and supervision of use and establishing a European Medicines Agency on the European Parliament and of the Council amending Regulation (EC) No 1782/2003 the inscription of the annex to Regulation (EC) No 726/2004, the drug product, if: 1) has been identified as a medicinal product was appropriate;
2) the product is not to be regarded as being dangerous to the health of the patient, the user or the public health and the veterinary medicinal product, taking account of the intended purpose thereof, be considered to be dangerous either to the consumer, the environment or animal, taking into account the beneficial effects of the preparation in relation to the quality, safety and efficacy of the risks (the risk-benefit ratio);
3) the product will meet the requirements for the manufacture of a Pharmacopoeia or other similar and quality standards;
4) drug and medicinal effects in preclinical and clinical studies is established by appropriate; and 5) composition of the preparation in question and all other information is duly reported.
(2009/773) Centre for the development of the pharmaceutical sector, security and may attach to the terms of a marketing authorisation of the medicinal product, provided that they are necessary in order to ensure correct and safe use of the medicinal product. Of the marketing authorisation of medicinal products falls within the scope of the directive, the Agency may, in addition to conditions for granting the authorization after the conclusion of the investigations, as well as the safety and effectiveness of the registration or the notification of suspected adverse reactions. Where appropriate, the terms of the marketing authorisation shall be fixed time-limits. (3.5.2013/330)
The marketing authorisation may be specific grounds relating to the safety or efficacy of the medicinal product, the conditional, so that the marketing authorisation holder shall have the obligation to carry out the measures provided for in the marketing authorisation. Centre for the development of the pharmaceutical sector in the security and shall publish the reasons why the marketing authorisation has been granted a suspended sentence as well as the edellyttämistään of the measures to be taken. The marketing authorisation holder shall make to the security and development of the pharmaceutical sector inquiry on the implementation of the terms of the marketing authorisation for a year. (2009/773)
The marketing authorisation is not required, has made use of radioactive are using radionuclide generators, excise duties, or radioactive solutions with the marketing authorisation.

21 (a) in the section (as of 4 November 2005/853) by way of derogation from article 21, paragraph 4, and without prejudice to the protection of industrial and commercial property, on the application of the legislation of the applicant shall not be required to provide the results of pre-clinical tests and the clinical trials of the veterinary medicinal product and not the results of safety and residue tests, if the applicant can demonstrate that the permission is applied for rinnakkaisvalmisteelle, which corresponds to a reference product which is or has been authorised in accordance with article 21 or to the members of the European economic area, or in the marketing authorisation granted by the European Community, at least for a period of eight years. If, in particular, for the preparation of pharmaceutical raw materials or manufacturing processes differ from those of the reference product, the results of the will of the applicant for marketing authorisation application in the pharmaceutical sector for the development of security and the imposition of pre-clinical and clinical trials separately. The Agency shall, where appropriate, provide more detailed provisions concerning the way in which the consistency of raw materials and production methods will be demonstrated. (2009/773)
The results of the appropriate pre-clinical tests and the clinical trials of the veterinary medicinal products also appropriate the results of safety and residue tests should, however, be sent, if the product is not fully compatible with article 5 (c) of the definition of the generic product, or if it has not been possible to demonstrate bio-equivalence studies on bio-therapeutic use or purpose of the product, or route of administration are different from the reference product.
The generic product, the marketing authorisation shall enter into force no earlier than ten years after the granting of the initial marketing authorisation of the reference product. If the holder of the marketing authorisation of the reference product be the granting of a marketing authorisation for the next eight years, the authorisation for one or more new therapeutic indications of a substance, which is a scientific assessment was considered to bring a significant clinical benefit in comparison with existing therapies, will not come into effect until 11 years after the marketing authorisation of the reference product in the original authorisation.
If a new active substance in veterinary medicinal product is intended for one or more of the production animal, shall be extended to the ten-year period referred to in paragraph 3, for a period of one year every once in a while, a new permit shall be extended to producing species. You can, however, be an extension of not more than three years. The extension is subject to the condition that an extension of the marketing authorisation shall be issued within five years of the authorisation of the reference product. The extension shall be subject, in addition, that the holder of the marketing authorisation is made in order to strengthen the Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards the maximum levels for the implementation of Council Regulation (EEC) No 2377/90, regulation, hereinafter referred to as the residue of an application for the establishment of residue limits of animal species. This event gained an extension will not be able to make the veterinary medicinal product on the market, the marketing authorisation of the reference product has been granted on or before 30 April 2004.
Fish or bees or other directive on veterinary medicinal products, in accordance with the procedure referred to in article 89 designated types of generic marketing authorisation as referred to in, however, will not come into effect until 13 years after the granting of the marketing authorisation of the reference product.

21 (b) of section (as of 4 November 2005/853) when applying for a marketing authorisation of medicinal product, the quality and quantity of the active substances and the same pharmaceutical form as in the past, the marketing authorisation holder of the marketing authorisation for the virtue of preparations and has given its consent to this application for marketing authorisation for the preparation of the documents of the pharmaceutical and pre-clinical tests and the clinical trials of the veterinary medicinal product, the results of research, as well as the use of the results of safety and residue tests, not the marketing authorisation application need to connect to the results of such studies.

21 (c) of section (as of 4 November 2005/853) by way of derogation from article 21, paragraph 4, and without prejudice to the protection of industrial and commercial property, the application of the legislation on the marketing authorisation, the applicant shall not be required to provide the results of pre-clinical tests and the clinical trials of the medicinal product and of the veterinary medicinal product nor the results of safety and residue tests, if he shows that the active ingredients contained in the product is consistently used medicinally in one of the plants belonging to the State of the European economic area, at least for a period of ten years, and their power has been recognized and their level of safety has been accepted. The power and level of safety will be in this case, the appropriate scientific literature shows the way for the development of the pharmaceutical sector, security and more. (2009/773)
If the medicinal product contains a number of authorised medicinal products, active substances used in the composition of which has not previously been used in combination for therapeutic purposes, is a combination of forward and pre-clinical tests and the clinical trials, as well as in respect of the veterinary medicinal product, including, where appropriate, the results of safety and residue tests. A combination of individual substances is not required to provide the results of these studies, however, nor the publication referred to in paragraph 1. Finally, the new combination of several pharmaceutical substances shall apply to the section 21 (a) of subsection 1 and comply with the deadlines from 3 to 5.

If antimicrobial approved adoption of a new general purpose on the basis of significant pre-clinical tests or new clinical trials, can be rinnakkaisvalmisteelle on the basis of these studies, to apply for a new intended use at the earliest one year after the change of the marketing authorisation of the reference product. The purpose of the new use of the limitation applies only to the first.
If the production of animals of veterinary medicinal products referred to in the product is new, in accordance with the regulation on maximum residue limits for residues, as well as new clinical trials in order to obtain a marketing authorisation for another food-producing species, and these studies have been taken into account for the granting of a marketing authorisation in accordance with paragraph 1, the applicant for marketing authorisation to refer to these to the other studies not earlier than three years after the granting of the marketing authorisation on the basis of the first.

Specific authorisation procedures (as of 4 November 2005/853), 21 (d) of section (2009/773) where a medicinal product which has been granted a marketing authorisation in Finland, will bring to a country other than the holder of the marketing authorisation or its importation by the authorized representative, the product to be rinnakkaistuontimyyntilupa. Centre for the development of the pharmaceutical sector, security and grant rinnakkaistuontimyyntiluvan, if rinnakkaistuotavan and between the product which has been authorised in the past is not a therapeutic difference. Rinnakkaistuontimyyntilupa may only be granted to a country of the European economic area, the State imported pharmaceutical product.

21 (e) of section (2009/773) in the pharmaceutical sector for the development of security and may be granted by section 21 (1) and (2) by way of derogation from the use of the medicinal product, the temporary permit if there are specific criteria for pathogenic agents, toxins, chemical agents or nuclear radiation any of the suspected or confirmed spread of, and there is no other appropriate treatment or medicine.

Article 21 (f) (16 October 2009/773) Centre for the development of safety in the pharmaceutical sector and the specific therapeutic or public health reasons, to be able to grant temporary authorisation, without prejudice to article 21 (special permit), and the disclosure of the medicinal consumption. Erityislupamenettelystä and special conditions can be adjusted more precisely the State Council regulation.

21 (g) section (2009/773) Notwithstanding the provisions of this Act provides for a sales permit, food safety can be a serious threat to animal disease and immunologiselle of the licence granted for a veterinary medicinal product that is not covered by a marketing authorisation, if an appropriate preparation is otherwise not available, or where the health situation so requires. The authorisation shall be notified immediately to the security and development of the pharmaceutical sector.

21 h section (16.5.2014/388) 21 (h) L:lla 16.5.2014/388 article has been repealed.

Registration (as of 4 November 2005/853) section 22 (2009/773) provided to the consumption of alcohol awarded must be registered in the traditional meaning of man. In the pharmaceutical sector for the development of the traditional security and provided to the register, if: 1) the product is suitable for use in their composition and their use without a doctor's diagnosis, by, on behalf of or for the prescription or monitoring of treatment;
2) is intended to be taken orally, topically, or inhalation preparation;
3 the safety as well as the traditional use of the product and) pharmacological effects and efficacy is sufficient information;
4) or the corresponding product with the same active ingredients, the same or similar intended purpose, the same strength and dosage as well as the same or similar route of administration as the product, has been used as a medicinal product before the date of application for a continuous period of at least 30 years, with 15 years in the State of the European economic area; and 5) a preparation does not meet the 21 or 21 c of the authorisation in accordance with article 22 (a) and in accordance with the conditions of registration.
If registration has been applied for the product, which has been used in the countries of the European economic area, less than 15 years and which otherwise meet the conditions for registration set out in subparagraph (1), the security and the development of the pharmaceutical sector shall bring the matter to the Committee for herbal medicinal products of the European Medicines Agency. From 15 years of operating time requirement may be waived, if the Committee shall draw up a community herbal monograph as a preparation. The plant at the time of the decision must be taken into account for the final monograph, unless otherwise provided in the specific lääketurvallisuuteen of the reason.
In the pharmaceutical sector for the development of security and can be attached to the registration conditions in order to ensure the correct and safe use of traditional phyto, as well as the terms of the place of sale.

22 (a) of section (2009/773) Consumption of the originators of a homeopathic preparation, which is not subject to the marketing authorisation in accordance with article 21 of the procedure, have to be registered. Centre for the development of the pharmaceutical sector, security and register this product, if: 1) is intended to be taken orally or externally; used for preparation of an animal may also be described in the rest of the pharmacopoeia;
2. the labelling of the product, or any related) information does not occur in a particular pharmaceutical use;
3) does not contain more than one ten thousandths of the stock, or more than 1/100th of the smallest dose used, requiring a doctor's prescription drug dose; and 4) a preparation does not meet the section 21 of the authorisation in accordance with the conditions.
In the pharmaceutical sector for the development of security and can be attached to the registration conditions in order to ensure the safe and correct use of the product, as well as the conditions of the place of sale.
As a pharmacist in excess of the homeopathic product is not registered, but prior notification must be given to the security and development of the pharmaceutical sector.

Miscellaneous provisions (as of 4 November 2005/853) section 23 (2009/773) Centre for the development of security and in the pharmaceutical sector will need to take to the granting of the marketing authorisation and registration and the issue of the amendment of the proprietary medicinal product when dealing with regard to the second part of the European economic area, the competent authority in the State of pending applications as well as the decisions taken by the competent authority, as well as comply with the European Union's institutions, the granting of a marketing authorisation, amendment and withdrawal of the authorisation of the medicinal or drug consumption, a ban on extradition decisions as provided for in the acts of the European Community.
Subject to security and development in the pharmaceutical sector, the Centre may accept another State belonging to the European economic area, the people approved or proposed by the proprietary medicinal product referred to in the assessment report, summary of product characteristics, labelling and package leaflet or serious risk to public health, or in respect of the veterinary medicinal product to humans, animals or the environment because of the potential risk, it shall give a detailed exposition of the reasons for its position to the Member State concerned and the marketing authorisation or the registration or its amendment to the applicant. Centre for the development of security and in the pharmaceutical sector will need to take into account the instructions of the European Commission, a serious risk to public health or to humans, animals or the environment which might arise from the risk assessment.
If, in addition to one or more of the States members of the European economic area, the competent authority of any pending application for medical monitoring have been referred to the European Union institutions, any other authority than the safety of the pharmaceutical sector and by the Centre for the development of the Centre at the request of the applicant, in spite of this, may be granted for the marketing authorisation of the medicinal product. Resolution of the European Union's institutions, the Centre for the development of security and in the pharmaceutical sector will on its own initiative, to take measures to amend the European Union has granted the marketing authorisation to comply with the decision of the institution.
Sales permit or any other authorization relating to the donation of the consumption of the proprietary medicinal product shall not be granted in respect of veterinary medicinal products intended for food-producing animals, which is, and which contain certain substances having a hormonal or thyrostatic action and beta-agonists in livestock production and directives 81/602/EEC, 88/146/EEC and 88/299/EEC are laid down in Council Directive 96/22/EC, referred to in those having a tyreostaattisesti or beta-agonistisesti active substances, unless the purpose of the use of the medicinal product have not been adopted in the directive.

23 (a) section (2009/773) if the marketing authorisation of the medicinal product or to register you want to change, or when a change of technological and scientific development of the product, the holder of the marketing authorisation or registration to make this application for security and development in the pharmaceutical sector. The Centre will need to accept the change, if it complies with the requirements laid down in the authorisation or registration margin you want to change. Centre for the development of security and in the pharmaceutical sector shall be an application submitted to all the Member States which have granted the marketing authorisation for the medicinal product drug pursuant to the directive. The proprietary medicinal product on all subsequent strengths, pharmaceutical forms, administration routes and types of packaging, as well as all changes and extensions will be part of the original marketing authorisation or registration, subject to those not retrieved individually for a marketing authorisation or registration. The changes, which do not substantially affect the preparation of the assessment of the marketing authorisation or registration conditions, however, it is only to inform the Centre for security and development in the pharmaceutical sector. (13.12.2013/978)

If the marketing authorisation or registration of a medicinal product is a time-limited, modified the permit or the registration is in force, in accordance with the original time limit.
In the pharmaceutical sector for the development of security and to provide more accurate and (2) the provisions referred to in the application for the change of the notification of the changes, the change, and the applicable procedure.

section 23 (b) (as of 4 November 2005/853), If the marketing authorisation by the proprietary medicinal product may not be delivered to the referred to the people only on the basis of a medical prescription (prescription), has been removed from the holder of the marketing authorisation on the basis of the carried out by extensive pre-clinical tests or new clinical trials, can another of the same active substance the holder of the marketing authorisation for a medicinal product to apply for the removal of the condition on the basis of these studies, the prescription at the earliest one year after the amendment of a condition of the marketing authorisation of the reference product.

Article 23 (c) (3.5.2013/330) in the pharmaceutical sector for the development of security and can decide on the scope of application of the directive in the field of medicine following the granting of a marketing authorisation, the marketing authorisation holder shall take the safety or effectiveness of the research.
A safety after marketing authorisation has been granted, may be imposed for the safety of the medicinal product, if it is justified on the basis of the information received, after the granting of the marketing authorisation. If the same safety information for more than one medicine, Centre for the development of the pharmaceutical sector, security and must consult the Committee of the European Medicines Agency, the pharmacovigilance risk assessment of the common security research.
The effectiveness of the research after the granting of a marketing authorisation may be imposed, if the data obtained from the clinical research methods or otherwise give an indication of the effectiveness of the previous estimates may need to be significantly revised.
The security and the development of the pharmaceutical sector shall notify the holder of the marketing authorisation for a written notice of intention to impose an obligation for the period after the granting of a marketing authorisation, the effectiveness-or turvallisuustutkimukselle. The research is to be justified, and the implementation of the objectives of the study must be mentioned in the notice and the schedule. The marketing authorisation holder shall have the right to security and the development of the pharmaceutical sector within an appropriate time-limit on the validity of the written comments submitted by the research if the marketing authorisation holder requests this within 30 days of the date of receipt of the written notification.
If the safety of the pharmaceutical sector and the imposition of an obligation, the obligation to decide on the development centre will be part of the marketing authorisation. The holder of the marketing authorisation shall accordingly be updated risk‐management process in this regard.

section 24 (2009/773) 21 and 21 (a) – 21 (d) the authorisation referred to in article 22 (a) of section 22 and the registration referred to is in force for a period of five years from the time the licence or registration was issued for the first time. The authorisation and registration can be renewed. The renewed authorisation and registration are valid for an indefinite period, subject to the security and development of the pharmaceutical sector lääketurvallisuuteen reasons, that also renewed the permit or the registration is valid for a period of five years. After the reform of the authorisation and registration of the second five-year term are valid until further notice.
An application for a marketing authorisation or renewal of the registration must be done by the Centre for security and development in the pharmaceutical sector in writing no later than nine months before the expiry of the licence or registration. In the case of a veterinary medicinal product falling within the scope of the directive of the medicine, the application must be made at least six months before the expiry of the licence or registration. (3.5.2013/330), section 25 (as of 4 November 2005/853) 21 and 21 (a) – 21 (d) the authorisation referred to in article 21 (e) of provisional authorisation referred to as well as the registration may be granted to natural or legal persons who are established in the European economic area, forming part of the State.
Special permission may be granted to the pharmacy, pharmacy, hospital pharmacy, the page-pharmacy, medicine wholesale, medicine factory, for the health and well-being of the institution, the Elintarviketurvallisuusvirastolle and the Finnish Red Cross. (2009/773)
The registration and the amendment of the authorisation and the application for or renewal of the safety of the pharmaceutical sector and the development of written and signed application. Also, section 23 (a) is applied, the Declaration referred to in subparagraph (1) to be done by the Centre for security and development in the pharmaceutical sector in writing and a statement has to be signed for. In the pharmaceutical sector for the development of security and provide more detailed provisions on the conclusion of the submission of applications and notifications provided for in this chapter, as well as the reports attached to this, as well as the inclusion of the labelling and package leaflet/insert the medicine package. (2009/773)
The time during which the permit, registration, change or the request for renewal must be solved, provided for the Council of State regulation.

25 (a) in the section (3.5.2013/330), the Centre for the development of pharmaceutical safety assessment report shall be drawn up and the medicine which is the subject of an application for a marketing authorisation. The assessment report shall be updated whenever the quality of the medicinal product, the safety or efficacy of new significant information. The assessment report and the reasons for it, which has been removed from the business and the information covered by professional secrecy, shall be made available to the public. The assessment report shall include a summary, which contains the terms and conditions of the contribution of the medicinal product. Centre for the development of the pharmaceutical sector in the security and shall publish the decision of the marketing authorisation for the medicinal product, the terms of the marketing authorisation and, where appropriate, information on the fulfilment of the conditions that are attached to the relevant time-limits, the summary of product characteristics and the package leaflet.
In the case of a veterinary medicinal product falling within the scope of the directive of the pharmaceutical product, the safety and the development of the pharmaceutical sector shall be drawn up, to be made publicly available and update the assessment report as provided for in subparagraph (1), however, without a summary. The scope of application of the directive on veterinary medicinal products shall be published in the marketing authorisation of the medicinal product covered by the decision, the summary of product characteristics and the package leaflet.

Article 25 (b) (3.5.2013/330) in the pharmaceutical sector for the development of security and can, for a justifiable reason, grant exemptions from the labels and package leaflets for medicinal products regarding the information to be given to the provisions of the exemption from the obligation to draw up rules for the labelling and the package leaflet of the medicinal product in the Finnish and Swedish language, if the product is not intended to be delivered directly to the patient or, if the supply of the medicinal product in respect of the granting of exceptions in the event of serious and present a danger to human or animal health.

Article 26 (as of 4 November 2005/853) the holder of the marketing authorisation, the holder of the registration provided for in article 22, shall ensure that the authorised medicinal product, as well as to register traditional herbal medicinal product may rely on the wholesale of medicines and pharmacies is constantly available to patients, and the need for other users.

The reporting obligation (as of 4 November 2005/853) section 27 (13.12.2013/978), the marketing authorisation holder shall inform the registration, rinnakkaistuontimyyntiluvan and safety of the pharmaceutical sector and the development of the proprietary medicinal product: 1) trade into eight working days before the start of the sale;
2 ad hoc or permanent suspension of the import trade), as well as the reasons for these measures in respect of medicinal products for human use for at least two months before the sales suspension, unless specific reasons.
The marketing authorisation, the holder of the registration, in addition to rinnakkaistuontimyyntiluvan and inform the security and development of the pharmaceutical sector Centre on the end of the marketing of the medicinal product, or suspension or revocation of the marketing authorisation, the marketing authorisation for the renewal of the non-related measures, as well as such measures apply. If such measures are based on the drug's harmfulness, the negative risk-benefit ratio of the power of, or problems related to the safety of medicinal products, the announcement is to be made at the European Medicines Agency. If the steps have been taken outside the territory of the EU and the EEA, the efficacy of the medicinal product, the harmfulness of the risk-benefit ratio, negative or on grounds relating to the safety of medicinal products, it shall, without delay, notify the safety and development of the pharmaceutical sector and the European Medicines Agency.
Displayed to the user if other than the holder of the marketing authorisation or its representative is going to bring to Finland of the medicinal product for which an institution of the European Union has authorised the import, the importer shall notify to the security and development of the pharmaceutical sector and the marketing authorisation holder. The notification shall be made at least one month before the start of the planned imports.
Section 2 of this article shall not apply to veterinary medicinal products.

Payments in accordance with § 28 (2009/773) 21 and 21 (a) – 21 (g) of section 22 and the authorisations referred to in article 22 (a), referred to in article 23 (a) registrations, as well as for the marketing authorisation, and to change the registration are subject to a charge. Fees may be set to run in advance. In addition, the promise and the measures taken in relation to the registration of charges may be levied for the payment of all or part of the year. The fees provided for in the regulation, more specifically the Ministry of Social Affairs and health, taking into account the State of payments made under the law or under the cash basis. Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on the payments.

The Commission on: expiry or revocation of the marketing authorisation and registration (as of 4 November 2005/853)


section 29 (as of 4 November 2005/853) and the registration shall lapse if the holder: 1) is not made conditional marketing authorisation within the meaning of section 21 of the annual report within a time limit;
2) has not paid the annual fee referred to in article 28; or 3) has not brought the product to trade within three years of the granting of the marketing authorisation or registration or marketing has been suspended for a period of three years.
In addition, the Centre for the development of the pharmaceutical sector in the security and of the marketing authorisation and registration can be cancelled, if the latest studies or otherwise, it has been established that the conditions for the granting of the authorization or registration is no longer the case. The authorisation and registration can be temporarily withdrawn, in respect of the performance of studies necessary for, if there is reason to believe that the conditions for the granting of the marketing authorisation or registration is no longer the case. (2009/773)
Centre for the development of security and in the pharmaceutical sector can be human or animal health or for other special reasons, the holder of the marketing authorisation or registration application decide that the marketing authorisation, or registration under the grounds referred to in paragraph 3 of the tenant. The holder of the marketing authorisation and registration is to be done by the Centre for security and development in the pharmaceutical sector application for authorisation or registration continued for at least three months before the expiry of the three-year period. The security and the development of the pharmaceutical sector shall be the decision of the fact within one month of the date of receipt of the application. (2009/773) 4 L:lla 3.5.2013/330 is repealed.
Of the studies referred to in paragraph (2) of the expenses incurred may be provided in whole or in part, the holder of the marketing authorisation or registration.
4 (a) in the figure (3.5.2013/330) pharmacovigilance scope and definitions (3.5.2013/330) section 30 (3.5.2013/330), the provisions of this chapter shall apply to marketing authorisations for medicinal products falling within the scope of the directive and section 22 of the registrations under the.
This chapter shall not apply to veterinary medicinal products falling within the scope of the directive, with the exception of the person responsible for pharmacovigilance, adverse reaction reporting, errors in the register and provided 30 (c), 30 (e) and 30 o.

section 30 (a) (3.5.2013/330) in this chapter, the following definitions shall apply: 1) adverse reaction to a medicinal product which is noxious and unintended;
2) pharmacovigilance system system, that the holder of the registration or the holder of the marketing authorisation for the medicinal products sector, security and the development of the use of the pharmacovigilance tasks and in the fulfilment of their obligations and to monitor the safety of medicinal products which have been authorised or registered, and can be detected in their risk-benefit in relation to the observed changes.
3) a detailed description of the pharmacovigilance system file of the pharmacovigilance system, the holder of the marketing authorisation and registration, which use one or more of the kind of medicine or preparation for, who has been granted a marketing authorisation, or that it is registered, and a set of 4) measures relating to pharmacovigilance, to proceed with riskienhallintajärjestelmällä, which is designed to identify the risks associated with medicinal products, to the question whether, for the prevention or minimisation of including the assessment of the effectiveness of the activities and the measures concerned.

The drug safety system, risk management system, and a side effect of the registry (3.5.2013/330) section 30 (b) (3.5.2013/330) for security and development in the pharmaceutical sector the Centre shall have a medical security system of pharmacovigilance tasks and for the participation of the European Union's pharmacovigilance. Data on the pharmacovigilance system is used for the use of the medicinal product shall be borne by the human adverse reactions, occurring in humans associated with exposure to occupational, as well as other risks of the medicinal product relating to patients ' health or public health.
Centre for the development of security and in the pharmaceutical sector, must be examined and assessed on a regular basis and report the results of the security system for medicinal products to the European Commission every two years.

section 30 (c) (3.5.2013/330), the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and registration must be in the drug safety system, which allows all the information of the medicinal product will be assessed scientifically, consider options to prevent and, as appropriate, are carried out in order to minimize the risks and appropriate measures.
The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and shall have permanently and continuously at his disposal the person responsible, which includes the promotion of drug safety and related tasks. The person responsible for pharmacovigilance shall be required by their duties, training and work experience. The person responsible for pharmacovigilance shall be on the territory of the European Union. The marketing authorisation holder shall inform the registration, rinnakkaistuontimyyntiluvan and pharmacovigilance the name and contact details of the person responsible for the security and development of the pharmaceutical sector, as well as the European Medicines Agency. Also within the scope of the directive on veterinary medicinal products belonging to the holder of the marketing authorisation for the medicinal product, and rinnakkaistuontimyyntiluvan must be continuously at his disposal the services of the person responsible for pharmacovigilance, the Member of the European Union shall be in the State.
In the pharmaceutical sector for the development of security and can give more specific provisions on the duties of the person responsible for pharmacovigilance.
Centre for the development of the pharmaceutical industry for security and can, if necessary, request the marketing authorisation, the holder of the registration to designate the rinnakkaistuontimyyntiluvan and at the national level, of the contact person responsible for pharmacovigilance reporting to the person responsible for pharmacovigilance.

30 (d) section (3.5.2013/330) in addition to what is provided for in section 30 (c) of the pharmacovigilance system, the registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and maintained by the pharmacovigilance system is: 1) be maintained in the pharmacovigilance system file;
2) to be kept for each medicinal product which are also included in the above for a comprehensive sales conditions attached to the permit;
3) the results of the monitoring of the measures designed to reduce the risks and who are included in the riskienhallintasuunnitelmaan, or the conditions set out in the marketing authorisation that are;
4) update and monitor pharmacovigilance data to implement risk management systems in order to assess whether the risks of the emergence of new risks, whether changed or whether the risk-benefit balance of the medicinal products.
The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and must be examined and assessed in the drug safety system, on a regular basis. The pharmacovigilance system database file must be added to the data of the main findings of the audit, and ensure that the findings are made and carried out the appropriate corrective action plan. Data can be deleted after. A copy of the database file shall, on request, provide the safety and development of the pharmaceutical sector within seven days of receipt of the request.
In the pharmaceutical sector for the development of security and can give more specific provisions on the adequacy of the content.

30 (e) section (3.5.2013/330), the marketing authorisation for the medicinal product provided to the holder of the registration rinnakkaistuontimyyntiluvan and should be considered in order to ensure patient safety and side effect of the registry. The register shall identify all the controller in order to ensure patient safety, the pharmaceutical and the information necessary for the preparation of medicinal products and suspected adverse reactions of the medicinal product for the user in relation to the diseases or tendencies, of all, the use of lääkitysten topics and to identify adverse reactions to medicinal products and medicinal products the user the necessary information, such as your name and social security number. If this side effect occurs in animals, however, the patient's information in the registry will be instead of the store to identify the necessary information, as well as the owner of the animal, the animal species. The data controller must notify the registry of the correctness of entries in the security and development of the pharmaceutical sector. In addition, the marketing authorisation holder shall inform the Agency for the development of the pharmaceutical sector in the security and of any prohibition or restriction imposed by the competent authorities of the countries where the product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the product.
Centre for the development of the pharmaceutical sector in the security and save the information referred to in subparagraph (1) ylläpitämäänsä the national side effect in order to ensure patient safety and to the registry. In the pharmaceutical sector, in addition to the security and development, the Centre may at any time request information on the risk-benefit balance of the medicinal product.

The marketing authorisation for the medicinal product, provided the holder of the registration as well as the rinnakkaistuontimyyntiluvan and the traditional Medicine industry security and maintained by the Centre for the development of a side effect to the information given in the register shall be used only for the monitoring and reporting of adverse effects of medicinal products, scientific research as well as the safety of medicinal products and the assessment of the risk-benefit ratio. The information may not, however, disclose or use the register for decision-making. Centre for the development of the pharmaceutical sector in the security and shall transmit to the information relating to the Health and well-being of the vaccine received. Information shall be made available to the security and development of the pharmaceutical sector from a side effect from the registry a technical connection. Before the opening of the technical use of the connection of the applicant must provide evidence of the fact that the data protection are taken care of in a proper manner.
Centre for the development of security and in the pharmaceutical sector can be a side effect of allowances held notwithstanding the provisions on secrecy, to dispose of personal information in the health care activity, disease prevention or treatment of or in accordance with the related for the purposes of scientific research, if the data subject's privacy policy to safeguard the personal data Act (523/1999). Before handing over the data to the data protection officer shall be given an opportunity to be heard. Complete information should be attached to the provisions necessary in order to safeguard the privacy of the data subject.
The marketing authorisation for the medicinal product, provided the holder of the registration rinnakkaistuontimyyntiluvan and keep the information on the side effects of 50 years from the end of the period of validity of the marketing authorisation or registration. The information shall be disposed of within one year, subject to the security and development of the pharmaceutical sector, for a special reason and decide that data retention is extended for a period not exceeding five years at a time. Centre for the development of security and in the pharmaceutical sector will retain the information side effects of 50 years of registration.
The national side effect in the registry also provides health care to the State law on personal registers (556/1989). In the pharmaceutical sector for the development of security and to provide more accurate data, the provisions on the notification of the adverse effect register and the safety and development of the pharmaceutical sector. Centre for the development of the pharmaceutical industry for security and can, if necessary, to give the drug to prescribe or supply medicinal products, the rules on reporting of side effects.

30 (f) of section (3.5.2013/330) in addition to the 30 (e) in section rinnakkaistuontimyyntiluvan, provides for the registration of the holder of the marketing authorisation, and shall record all the information on the territory of the European Union or in third countries, placed on the side effects of, regardless of whether they are patients or health care professionals to the declarations or whether they are encountered in the granting of the marketing authorisation or registration. The holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and registration is to ensure that the ads are in the territory of the European Union available from a single point of contact.
The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and shall notify by electronic means all the territory of the European Union reports of suspected serious adverse reactions to the competent authority of the Member State in whose territory the incident occurred. If you suspect a serious side effect occurs outside of the European Union, the holder of the marketing authorisation, it shall inform the registration rinnakkaistuontimyyntiluvan and the European Medicines Agency, as well as, on request, to the competent authorities of the Member States where the medicinal product has been granted a marketing authorisation. The notification must be made within 15 days from the date on which the registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and got the case.
In the pharmaceutical sector for the development of security and to announce the information received in Finland about the serious side effects of the European Medicines Agency, the EudraVigilance database, without delay and in no case later than 15 days after the date of receipt of the notification of the adverse effects.
On the Community code relating to medicinal products for human and veterinary use procedures for the authorisation and supervision of medicinal products and the European Medicines Agency, the European Parliament and of the Council on the establishment of Regulation (EC) No 1782/2003 in accordance with article 27 of Regulation (EC) No 726/2004 of the European Medicines Agency for the monitoring of the medicinal products containing the active substances referred to in the list of publications of marketing authorisation holders do not have to inform the EudraVigilance database the suspected side effects, which are mentioned in the ledger entry tables listed in the medical literature. Marketing authorisation holders must, however, follow all the other medical literature and report all suspected adverse reactions.
The holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and registration is to establish a procedure in order to obtain precise and verifiable information about suspected adverse reactions to the scientific evaluation of the notifications. The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and is also following up on the information and send the notifications to be collected updates for security and development in the pharmaceutical sector. The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and shall cooperate with the Member States, the European Medicines Agency and the particulars of suspected adverse reactions to detect duplication.

30 (g) section (3.5.2013/330), the Centre for the development of safety in the pharmaceutical sector, and shall notify The Agency of all suspected serious adverse reactions, of which it is informed of a health care professional or patient. The Centre shall forward to the ads electronically to the EudraVigilance database within 15 days of the date of receipt of the notification. In addition, the Centre for the development of the pharmaceutical sector, security and to announce their side effect in the register of the information of all whose notifications, including personal data, the holder of the marketing authorisation or registration.
Centre for the development of the pharmaceutical sector in the security and shall inform the social and health care sector for the authorisation and supervision of the Agency, as well as the health and well-being of the institution's notification of the error in the use of the product to the attention of the customs duties due to suspected adverse reactions. In the field of Social Affairs and health for the authorisation and supervision of the Agency, as well as the health and well-being of the body shall immediately notify the Centre for security and development in the pharmaceutical sector suspected adverse reactions which are brought to their attention.
The security and the development of the pharmaceutical sector must act in cooperation with the European Medicines Agency and the marketing authorisation holders with notifications of suspected adverse reactions to detect duplication.

Information (3.5.2013/330) 30 (h) section (3.5.2013/330) in the pharmaceutical sector for the development of security and maintains the national medicines on the Web site, which is linked to on the Community code relating to medicinal products for human and veterinary use and procedures for the authorisation and supervision of use and establishing a European Medicines Agency on the European Parliament and of the Council amending Regulation (EC) No 1782/2003 in accordance with article 26 of Regulation (EC) No 726/2004 of the European pharmaceutical sector, set up a Web site.
Centre for the development of the pharmaceutical sector, security and maintaining a website is 25 (a) in addition to the information laid down in article available to the public the following information: 1) summary of the medicinal products for which riskienhallintasuunnitelmista has been granted a marketing authorisation, or that is registered under this law;
2.) the list referred to in subparagraph (1) of the medicinal products referred to in article 23 of the regulation;
3.) various ways in which a health care professional or patient may report suspected adverse reactions to medicines safety and the development of the pharmaceutical sector.

30 (i) section (3.5.2013/330) If the registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan or will issue a general communication on the use of the medicinal product, the holder of the safety of the drug suspicions shall, without delay, and no later than at the time of adoption of the communication, notify the Centre for security and development in the pharmaceutical sector, the European Medicines Agency and the European Commission.
The registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and shall ensure that the information to be supplied to the public is presented objectively and is not misleading.

Article 30 (j) (3.5.2013/330), the Centre for the development of security and in the pharmaceutical sector shall be notified to the European Commission, the European Medicines Agency and of the States members of the European economic area, to the competent authorities information on pharmacovigilance doubts as to the general communication for at least 24 hours prior to its adoption, unless it is not a public health protection, on the communication from the urgent procedure as required.
If the public communication is included in the personal data or business secrecy, security and development in the pharmaceutical sector, the Centre may act on the openness of government activities (621/1999), as well as the provisions of the personal data Act, without prejudice to the provisions governing the processing of personal data shall inform such information to the extent that the disclosure is necessary for the protection of public health.

Periodic (3.5.2013/330), section 30 k (3.5.2013/330)


The holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and the registration shall be made by electronic means to the Agency for the development of the pharmaceutical sector, security and periodic, which include: 1 the point of view of the benefits and risks of the medicinal product in the relevant) data summaries, as well as the results of all investigations, with the possible impact of a marketing authorisation of the estimated data;
the risk-benefit balance of the medicinal product 2) scientific assessment;
3) all of the medicinal product and the holder of an authorisation for the information on the number of prescriptions, as well as an estimate of the population of the altistuneesta of the medicinal product.
By way of derogation from paragraph 1 (a), 21 (c), 21, 22 and 23 (a), of the marketing authorisation referred to in article rinnakkaistuontimyyntiluvan or the registration holder shall provide periodic only if: 1) to the Centre for the development of safety in the pharmaceutical sector and has set this as a condition of the marketing authorisation for the obligation under section 21 or 23 (c) of the code; or 2) for security and for the development of the pharmaceutical sector requires this based on the data relating to pharmacovigilance, to proceed with doubts, or on the basis of the active ingredient in turvallisuuskatsauksia following the granting of the marketing authorisation for the fixed-term contract is not provided.
Fixed-term contracts, periodic safety update report frequency must be mentioned in the decision on the authorisation and registration. Periodic safety update report, delivery dates shall be calculated from the date of adoption of the decision.

Urgent EU procedure (3.5.2013/330), section 30 l (3.5.2013/330), the Centre for the development of security and in the pharmaceutical sector shall be brought the medicine referred to in article 107 of the directive in an urgent procedure of the Union, if it is deemed necessary as a result of the evaluation of pharmacovigilance data, by informing the other Member States of the European Union, the European Medicines Agency and the European Commission. Pressing procedure must be initiated by the Union, if the security and development of the pharmaceutical sector: 1) is considering the withdrawal of the marketing authorisation or registration temporarily or permanently;
a ban on the supply of the medicinal product, considering the 2);
3) is considering the renewal of the refusal to grant an authorisation or registration;
4) is received from the holder of the marketing authorisation or registration information, the fact that this is a security measure: (a) the placing on the market of the medicinal product) suspended;
(b)) taken or intends to take steps to withdraw the marketing authorisation or registration;
(c) the renewal of the marketing authorisation is not requested); or 5) is of the opinion that the new recommended dosage just to add a topic, the reduction or limitation of the uses of a medicinal product, it is necessary to implement as a matter of urgency.
(13.12.2013/978) If the measures referred to in paragraph 5, subparagraph 1 does not need to be a matter of urgency, to the security and development of the pharmaceutical sector must, however, make the Declaration referred to in subparagraph (1), if it considers the measures despite the need. (13.12.2013/978)
In cases where the medicinal product has a marketing authorisation, or registration in more than one Member State, the urgency procedure in accordance with the provisions of this directive medicinal products.
In cases where urgent action is essential to protect public health, safety and development of the pharmaceutical sector, the Centre may suspend the placing on the market of the medicinal product concerned, and to ban its use, until such time as a definitive decision has been made. Centre for the development of safety in the pharmaceutical sector, and shall, not later than the next business day to inform the European Commission, the European Medicines Agency and the other Member States of the reasons for its action.

After the granting of the marketing authorisation and registration of safety studies (3.5.2013/330) 30 m section (3.5.2013/330), the granting of the marketing authorisation and registration of the post-rinnakkaistuontimyyntiluvan security research, which is carried out in the non-intervention of the labour force survey, shall not be performed if the use of the medicinal product research to promote. Health care professional gets paid for the period and on the participation of security only the remuneration for the costs incurred.
Centre for the development of the pharmaceutical sector, security and may require the marketing authorisation holder to submit the registration, rinnakkaistuontimyyntiluvan and research plans and reports on the progress of the investigation to the competent authorities of the Member State in whose territory the investigation is to be made.
The marketing authorisation, the holder of the registration rinnakkaistuontimyyntiluvan and 12 months after the end of the data collection, set the final report made available to the competent authorities of the Member State in whose territory the investigation is to be made. The marketing authorisation holder shall inform the registration, rinnakkaistuontimyyntiluvan and the new information, which may have an impact on the assessment of the risk-benefit balance of the medicinal product, the competent authorities of the Member State where the medicinal product has been granted a marketing authorisation.

30 's section (3.5.2013/330) in addition to the 30 m, as a condition of the marketing authorisation for 21 and 23 on the basis of the limit set out in section (c) of the conclusion of the safety investigation shall comply with the provisions of this article.
The holder of the marketing authorisation and the rinnakkaistuontimyyntiluvan before the security research plan for security and development in the pharmaceutical sector, where research is to be done only in Finland. The Centre shall, within 60 days of the date of receipt of the research plan be adopted in the study plan or study. The investigation may be launched but the safety of the pharmaceutical sector and the Centre for the development of written confirmation. The strengthening of the research plan is subject to the condition that the reservation is not conducive to the use of the medicinal product, the design of the study meets the objectives of the study and the research is not a clinical medicine research.
After the commencement of the research plan, prior to their implementation of major changes in the field of security and inform the Medical Centre. Centre for the development of the pharmaceutical sector in the security and shall assess the changes and notify the marketing authorisation holder or the Suppression of them.
When the research has been completed, the final report shall be submitted by the Centre for security and development in the pharmaceutical sector, within 12 months of the end of the data collection, subject to the security and development of the pharmaceutical sector is not given in writing on this issue.
The holder of the marketing authorisation and rinnakkaistuontimyyntiluvan the results of the investigation shall also assess whether there is an impact on the marketing authorisation, and, where appropriate, to provide the security and the development of the pharmaceutical industry in the marketing authorisation application for.
If the test is carried out by several Member States, the research plan, study plan and the final research report of major changes shall be submitted to the Committee, which decides on the pharmacovigilance risk assessment research plan for the approval of research, and the delivery of the final report on the exemption.

30 o § (30.12.2013/1200) the marketing authorisation, the holder of the registration rinnakkaistuontimyyntiluvan and shall immediately inform the Agency for security and development in the pharmaceutical sector on its own initiative, the efficacy of the medicinal product or the Elimination of the sale of, or the security of the product distribution of the suspension, as well as for the manufacture of proprietary medicinal product-related pharmaceuticals factory suspected of donated product. In addition, the registration of the holder of the marketing authorisation, rinnakkaistuontimyyntiluvan and must inform the Centre of detected or suspected counterfeiting of medicinal products.
Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on the notification of errors and the doubts of the pharmaceutical product counterfeit.

30 p section (30.12.2013/1200) the Centre for the development of the pharmaceutical sector in the security and early warning must be given without delay to all the Member States and to all operators in the supply chain of the national drugs situations, where the medicinal product suspected of causing a serious public health hazard, and that the product is first identified in Finland. If it is found to have arrived at such medicines to the patients, the safety and the Centre for the development of the pharmaceutical sector shall, without undue delay, to be informed on the matter.
Chapter 5 of the Pharmaceutical Sales pharmaceutical factory and the pharmaceutical wholesale trade as well as medicinal products (30.12.2013/1200) the pharmaceutical section 31 (opening/1112) Pharmaceutical Factory to be sold or otherwise available to pharmaceutical substances and plant their own pharmaceutical products only one pharmaceutical factory, wholesale trade in medicinal products, pharmacy, pharmacy, hospital pharmacy, a page-down to the Pharmacy and medicine. Pharmaceutical products, which are not provided for or prescribed to be sold only in pharmacies, will in addition, sell and otherwise dispose of these products to retailers.
Medicine factory is permitted to sell or otherwise dispose of medicines and pharmaceutical products also has its own University, and the scientific research institution for the research activity. Medicine factory will make this notification to the security and development of the pharmaceutical sector.
Finnish outside of the medicines may not be delivered to the pharmaceutical factory just a operator, which is in the country legally allowed to buy drugs from a pharmaceutical factory. (30.12.2013/1200)

The exercise of section 32 of the pharmaceutical wholesale trade (as of 4 November 2005/853) wholesale trade refers to all the activities carried out in a professional manner and for consideration, with a view to:

1. acceptance of orders and other medicinal products) as referred to in paragraph 2;
the acquisition and possession of medicinal products) to be forwarded to the dispensaries, social services and healthcare services and the other 35 34 of this law, and to the parties referred to in article 88; or 3) medicines to export from the country.
(30.12.2013/1200) There is, however, no wholesale of medicines and pharmaceutical products in accordance with article 38 of the population, the provision of medicines and pharmaceutical products to the pharmacy to another pharmacist or social and health policy unit, the hospital pharmacy or medical supply of medicines and medical products Centre 62 section and the holder of the marketing authorisation or his representative by the marketing and billing, which is not related to the possession, distribution, and storage of the products.
Wholesale trade may be carried out only to the security and development of the pharmaceutical sector. Permission is granted under the condition that the applicant on appropriate premises, installations and equipment, in order to maintain and to ensure the functioning of the medicinal products, as well as that the applicant has the required activities of the staff. I promise can be attached to the activity. Centre for the development of safety in the pharmaceutical sector and is responsible for the authorization to export to the European Medicines Agency to maintain data related to the database. (30.12.2013/1200)
In the State of the European economic area, in accordance with the provisions of the European communities and the recognition of the authorisation granted to the wholesale trade and the time within which an application for authorisation has to be resolved, provided for the Council of State regulation.

Article 33 (30.12.2013/1200) the pharmaceutical wholesale trade has to be employed under the direct employment by the responsible manager, who is responsible for ensuring that the pharmaceutical wholesale drugs comply with those in the law or the provisions adopted pursuant thereto, the following requirements in respect of the wholesale distribution of medicinal products are complied with and that the retention of the medicinal products, the processing and labelling regulations. In addition to the liability of the Director shall be responsible for the appropriateness of the pharmaceutical wholesale trade in medicinal products in the distribution.
The responsibility of the Director of the pharmaceutical wholesale trade must be a licensed pharmacist. The responsible manager must not be at the same time under the responsibility of the Director of another company, which has been given permission to engage in wholesale trade in medicinal products. The responsible manager shall not be subject to the liability of a Director of another company's pharmaceutical factories and pharmacies, hospital pharmacy or medical center nurse, the Director of the military pharmacy or a pharmacy or a pharmacy attendant. page The responsibility of the Director's qualifications can be adjusted more precisely the State Council regulation.
The pharmaceutical wholesale trade must be reported immediately to the security and development of the pharmaceutical sector, as well as, where appropriate, on the sales receipt or the holder of the authorization of the wholesale trade of medicinal products supplied, which it finds or suspects to be counterfeit medicines.

section 34 of the pharmaceutical wholesale trade can be used to sell or otherwise dispose of drugs the pharmaceutical factory, the other medicine wholesale trade, pharmacy, pharmacy, hospital pharmacy, a page-down to the Pharmacy and medicine and veterinarian veterinary medicine in the country. Pharmaceutical products, which are not provided for or prescribed to be sold only in pharmacies, will in addition, sell and otherwise dispose of these products to retailers. When you sell or otherwise dispose of the pharmaceutical wholesale drugs outside the territory of the EU and the EEA, it must ensure that the medicines will be delivered only to an operator, which is in the country legally allowed to buy drugs in the pharmaceutical wholesale trade. When selling or otherwise transfer outside the territory of the EU and the EEA medicines, which wholesale is received from outside the EU/EEA area, without having to be imported to the territory of the Union, the wholesale trade is to ensure that the medicines are purchased only from persons who are authorized or entitled to supply medicinal products in that country in wholesale trade. (13.12.2013/978)
Pharmaceutical wholesale may also sell or otherwise dispose of medicines for the rest of the trader to be used for any purpose other than as a medicinal product in the production activities, as well as drugs under section 17 of the service referred to in paragraph 5 of the universities, higher education institutions and scientific research institution for the research activity. (as of 4 November 2005/853)
When drugs and (2) and to the provision for the buyers, the medicine shall be accompanied by a document containing the information relating to the medicinal product. In the pharmaceutical sector for the development of security and can give more detailed information, as well as the provisions of the document of the important procedures for drug wholesalers to ensure jakelemiensa drugs suppliers and recipients of the legal right to supply medicinal products to send and receive. (30.12.2013/1200)

Medicinal products (30.12.2013/1200) section 34 (a) (30.12.2013/1200) the Drug has refers to all the activities carried out in a professional manner and for a consideration, of: 1) which relates to the sale of medicinal products or for the purchase, but that there is no wholesale trade;
2) which is not part of the physical handling of medicinal products; and 3) which consists of, on behalf of the legal person or natural person independently of the negotiations.
Myyntiluvallisten or registered medicinal products for human use, the broker must have a permanent address in the territory of the European Union. In Finland it is the task of the intermediary of medicinal products established in the notice of arbitration activities in the security and development of the pharmaceutical sector prior to the commencement of operation of the register. The Centre shall publish registered brokers on the Internet home page. The Centre may give more specific provisions on the requirements for the transmission of the medicinal products and the notification procedure as well as the registration of intermediaries.
Pharmaceutical retailer shall immediately notify the safety and development of the pharmaceutical sector and, where appropriate, on the sales of medicines supplied to the holder of the authorization of the intermediary, for which the Broker finds or suspects to be counterfeit medicines.

Miscellaneous provisions article 35 (a/700) the medicine factory and a pharmaceutical wholesale trade may be handed over to the free of charge medicines for doctors, dentists, veterinarians, as well as apteekkareille, the hospital pharmacy managers and medical center managers and emergency purposes. Pharmaceutical products, which are not provided for or prescribed for sale only in pharmacies, gets to dispose of these products to retailers. (as of 4 November 2005/853)
Medicine sample means the smallest packing size of the medicinal product, which will be handed over free of charge in the pharmaceutical or medical wholesale pharmaceutical preparation. The inactive part of the Pack is a special package, which is intended for the patient, free of charge, for the immediate initiation of treatment.
The provisions of the regulation of the Council of State to sample-and on the conditions and limitations of on-call for the packaging. In addition, the Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on the labelling of the packaging of the sample and on-call, and the monitoring of the use of the. (2009/773), section 35 (a) (2009/773) in the pharmaceutical wholesale trade will be a plan of action and guidance in order to ensure that the supply of the medicinal product can be effectively prevented, delivered medicine packages to track down and, if necessary, to remove from the market Centre for the development of safety in the pharmaceutical sector and the decision referred to in article 101, or the person responsible for the manufacturer of a medicinal product or a medicinal product the person responsible for the decision on its own initiative, suspend the distribution of the medicinal product.
The operation of the pharmaceutical wholesale trade shall comply with the provisions of the European communities, the distribution of medicinal products that are based on good practices. Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions in respect of the wholesale distribution of medicinal products to be followed of good medicine.

36 section (a/700) the wholesale distribution of medicinal products is to be considered in respect of the acquisition, importation of medicinal products, lists of storage and disposal. The lists shall be kept for at least five years. A list of contents and storage can be adjusted more precisely the State Council regulation.

section 37 of the pharmaceutical wholesale trade is to ensure that it is the need for a corresponding number of drugs for sale.

Article 37 (a) (13 January 2006/22) wholesale price must be the same for all healthcare products to pharmacies, and the page. Wholesale price, account shall be taken of all discounts, rebates and other healthcare products to pharmacies, and page, the granting of benefits. The wholesale price is the price of medicines information for those who like to be informed. The wholesale price of medicinal products and limitations may not apply to wholesale prices, which may be sold in pharmacies.
By way of derogation from article 1, for the distribution of medicinal products must provide a discount for performing mechanical dose dose distribution of the medicinal product to be used, which is the excess referred to in article 57 (c) the list of medicinal products and Health Insurance Act (1224/2004) of Chapter 6 of the reference price referred to in article 18 of the group. A discount may be given if the fixed reference price and the date of entry into force of the amendment used the medicinal product is more expensive than the new reference price. A discount may be given for a period not exceeding 30 days after the change of the reference price. (8 May 2009/311) Chapter 6 of the pharmacy in the General section 38 (opening/1112) in this Act, the following definitions shall apply:

1) be accredited by the medical care in the operating unit, which includes the retail, distribution and manufacturing of medicinal products and medicinal products, advice and service activities;
2) page separate points, to be accredited by the pharmacy industry is responsible for the pharmacy industry;
3) pharmacy service points operated by separate offices, from which the pharmacist can sell medicines;
4 the sale of medicines in the pharmacy network service client) via the Internet on the basis of the order;
5) pharmacy go pharmacy operations pharmacist page at the pharmacy, the pharmacy service point or through a pharmacy network services; and 6) apteekkarilla means any person to whom a permit has been issued to the pharmacy.

section 38 (a) (10.12.2010/1112) medicinal products may be sold only to the population in this Act, a pharmacist, the pharmacy, the pharmacist page referred to in the service point and the pharmacy network. 22 and 23 (a) traditional herbal medicinal products as referred to in section and also in the rest of the homeopathic medicinal products may, however, be sold, subject to the security and development of the pharmaceutical sector is not at the time of registration decided otherwise. In addition, nicotine products to be sold in other parts of the as article 54 (a) below.

Article 39 in the case of pharmacies in the country, so that the population will be, if possible, be able to vaikeudetta to get the drugs.

The right pharmacy with the carrying on of the 40 section (opening/1112) Pharmacy movement be allowed to engage in the safety of the pharmaceutical sector and with the permission of the Centre for the development of (pharmacy). A pharmacy permit shall be issued for a specific pharmacy or in the carrying on of the section. Pharmacy movement not to engage, in the case referred to in this Act, other than a pharmacy, the pharmacy, the pharmacy service point and the page on the pharmacy's website.
To ensure access to medicines in a pharmacy licence can be attached to a pharmacy shop opening hours or the maintenance of a pharmacist and pharmacy service point page.

41 section (opening/1112) is responsible for the development of the pharmaceutical sector, where appropriate, at the request of the security and to assess the effectiveness of services, integration in the area of Pharmacy and adequacy. The municipality may make a presentation to the Centre pharmacy, the pharmacist and pharmacy service point for the establishment of a page, or change the location of the area for the purpose of their transfer.
The establishment of a new pharmacy or its part to decide on the safety of the pharmaceutical sector and for the development of access to medicines. The decision will be taken on its own or on the initiative of the concerned Agency. Availability of medicinal products, shall be taken into account in assessing the population of the region, in an area already on the pharmacy services and other health services integration. The Centre may also decide the location of the area of the transfer of the Pharmacy and the pharmacy section of another, if it is necessary for the pharmacy services.
Centre for the development of the pharmaceutical sector, security and may decide to terminate the availability of medicinal products, if the pharmacy will no longer require the maintenance of the population of the region, area pharmacy the pharmacy services and integration with other health services. Dismantling of the decision must not be implemented before the pharmacy licence is made, unless the pharmacies have reported that they agree to the decision.
Centre for the development of the pharmaceutical sector, security and must consult the Committee before taking a decision referred to in paragraph 2 or 3.

Article 42 (opening/1112) at the University of Helsinki has the right to keep one of the Pharmacy at the University of Eastern Finland in Helsinki and one pharmacy in Kuopio. In addition to the sale of medicines in the pharmacy to pharmacy education and training related to the implementation of the pharmaceutical management of research.
The operator referred to in subsection 1, the pharmacy must be a licensed pharmacist. The pharmacy's hoitajasta will make a statement to the security and development of the pharmaceutical sector.

43 section (opening/1112) Centre for the development of security and in the pharmaceutical sector shall be liable to be declared the new or open to become a pharmacy permit to be picked up. Article 40 (2) of the conditions of the authorization referred to in the pharmacy is at the same time be made public.
Pharmacy laillistetulle to his pharmacist may be authorised. In addition, the condition that he has not been declared bankrupt, have not been provided for in the trustee and his kelpoisuuttaan.
A pharmacy permit shall be issued where the applicant may be full of more considered to be in the best position to a pharmacy shop. The evaluation shall take into account the conditions of the applicant's activities in the Pharmacy and other medical care tasks, including, where applicable, the moment of entry of a judgment which has become final the previous pharmacy licence, as well as the pursuit of the relevant studies, pharmacy movement leadership and the rest of the action.

44 section (opening/1112) the pharmacy licence is personal to you. Pharmacy movement may not be hired out or transferred to another. If the pharmacist receives a new pharmacy permit previously issued to him by a pharmacy permit at the same time.
Apothecary will actually take care of the pharmacy, except where this Act provides otherwise. Illness or other special reasons, pharmacies can leave for treatment of laillistetulle to his pharmacist or pharmacy laillistetulle farmaseutille total for a period not exceeding three months per year.
If pharmacies are an illness or other special temporary reason prevented from the pharmacy for more than three months, he has to inform the Centre for security and development in the pharmaceutical sector in order to be able, or pharmacist, to which he is appointed to manage the pharmacy during this time.
If the pharmacies in the situation referred to in article 46 is forced to engage in the movement of the two in a pharmacy, the pharmacy apothecary shall nurse the other pharmacies and shall forthwith inform the Agency for security and development in the pharmaceutical sector.

45 section (on 13 January 2006/22) Pharmacies allowed to pursue pharmacy movement until he fills 68 years.

The responsibilities of the pharmacist, in some cases, section 46 Apothecary is in section 44 and 45 in the case referred to in article or in the pharmacy, however, engage in a pharmacy licence to abandon its movement until the new pharmacies is taken to the pharmacy.

47 section (22.11.1996/895) a pharmacy, or in any way of the authorization is to be redeemed from the previous page pharmacy apteekkarilta Pharmacy and the fair price of the pharmacy's drug inventory page.

Lapse of an authorization and withdrawal of the section of Pharmacy 48 (2009/773) a pharmacy permit shall be deemed withdrawn if the pharmacist has not started a pharmacy within one year of the movement of the pharmacy of the notification of the decision to grant a permit or for the pharmaceutical industry for the development of security and not on the application for an extension of time.

49 section (opening/1112) if there is reasonable doubt as to the apothecary to the illness or for any other reason unable to perform the pharmacy itself or to the availability of services in the field of pharmacy, medicine, Centre for the development of the security and order him to obtain a medical examination or other appropriate examination.
In the pharmaceutical sector for the development of security and can not ban, the performance of the pharmacy or from taking part in the pharmacists temporarily to other pharmacy, if the meaning of the first paragraph of this suspected to be unable to deal with the availability of services to the pharmacy or a pharmacy. The ban may be issued for a period of up to one year at a time, or until the issue of his their people for their impotence is finally settled.

section 50 (opening/1112) Centre for the development of security and in the pharmaceutical sector shall withdraw the authorization if the pharmacy pharmacies: 1) is declared bankrupt or within one year of the commencement of bankruptcy proceedings will get his property back to the control over it;
2) is declared incapacitated;
3) loses the right to act as to registration as dental practitioner;
4) illness or intoxicating substances or as a result of drug addiction cannot be properly engaged in the profession of pharmacist;
5) becomes an illness or for any other reason to permanently disable itself to manage the Pharmacy;
6) offence to imprisonment for at least two years;
7) essentially to abuse the rights of Pharmacy licence;
8) receives a written warning as referred to in article 51 and the correct procedure;
9) is otherwise obviously inappropriate to engage in a pharmacy.

Disciplinary action under section 51 (2009/773) If a pharmacist is a pharmacist acting was in violation of this law or the provisions adopted pursuant to it or otherwise, of the consumer or negligence, or has been guilty of the Office behaved in an inappropriate manner and the inaccuracy or failure to have its quality, that he would be indicted by the Court, to the security and development in the pharmaceutical sector, the Centre may give him an oral or written warning.

Page 52 of the pharmacies section (opening/1112) for security and development in the pharmaceutical sector, the Centre may set up a page for the pharmacy's own initiative or at the initiative of the municipality or municipalities. In the pharmaceutical sector, in addition to the security and development, the Centre may set up a page on the application and the grant of permission to the pharmacy apothecary. The granting of the authorization is subject to the condition that, in order to ensure access to medicines needed for pharmacy services, rather than an independent pharmacy is not sufficient. The Agency may grant a pharmacy licence for not more than three page pharmacy.

Centre for the development of the pharmaceutical sector, security and decide on the location of the area of the page to the pharmacy. Centre may, on its own initiative or by the municipality, the municipality or at the initiative of the holder of the authorization to change the page the page the pharmacy in accordance with the location of the area in order to safeguard the availability of medicines in the pharmacy.
By way of derogation from paragraph 1, the University of Helsinki to the security and development of the pharmaceutical sector in each case with the keep up to 16 page from the pharmacy.
Page be accredited by the person in charge of the operation shall be determined by the pharmacist, the pharmacist or the pharmacist will be. Page hoitajasta a pharmacist shall be notified to the security and development of the pharmaceutical sector.
Page to the pharmacy opening hours and the range of medicinal products to be smaller than the needs of the local pharmaceutical service, be accredited by, if it is situated so permit.
If apteekkarilla is not authorized page pharmacy, the pharmacy may permit entry into the open side of pharmacy to treat article 46 for a pharmacy section of the movement from the carrier or 59 for pharmacy shop attendants, until the new pharmacies is taken to the pharmacy. After this, the new pharmacies allowed to care for the page from the pharmacy, until the page is finally settled on the maintenance of a pharmacist and pharmacies, for which an authorisation has been granted, will keep the page from the pharmacy.
Centre for the development of safety in the pharmaceutical sector and the provisions applying for authorization to provide pharmacy in laying down a procedure for the page.

Article 52 (a) (10.12.2010/1112) Pharmacies can be found in the security and of the Centre for the development of the pharmaceutical sector on the basis of the authorisation issued by the pharmacy service point of the sparsely-populated area or village center, if there is not sufficient conditions for the page to the pharmacy. Pharmacy service point can be set up for a special reason and also to the rest of the securing of access to medicines. Service point can be set up in the territory of the establishment or the pharmacist to be confined to the area. The application for a permit shall be accompanied by a plan showing how the below article 57 provided for medical advice. The central issue the authorization if the conditions laid down in this article are met.
Apothecary shall ensure the service point.
In the pharmaceutical sector for the development of security and can change the pharmacy service point page apteekiksi, if the point of sales is responsible for half the country's private page pharmacy sales average and page conditions otherwise are satisfied. the Pharmacy
In the pharmaceutical sector for the development of security and can not issue orders the service point of the activities, facilities, medicine, management and control.
Or at the University of Helsinki the University of Eastern Finland is the pharmacy cannot set up the pharmacy's service points.

Article 52 (b) (10.12.2010/1112), Pharmacies, pharmacy of the University of Helsinki and the University of Eastern Finland pharmacy can provide pharmacy services to the pharmacy network. Pharmacy network the service provider must have a website. Pharmacy online service that maintains a pharmacist must ensure that medicinal product on the market is legal in the country in which the medicine is sold. Pharmacy network for the maintenance of the service, prior notification must be given to the security and development of the pharmaceutical sector. Prior notice must be accompanied by a plan showing how the below article 57 provided for medical advice. The action may proceed, unless, within 60 days of the notification of the arrival of the Centre have asked for further clarification of the elements referred to in this article or banned activity. The material changes shall be notified to and. The activities of the Centre may prohibit or impose a Web service will cease to exist, if the conditions laid down in this article are not fulfilled. (30.12.2013/1200)
Prescription medications may not be delivered to the pharmacy e-commerce Web service only in the prescription of the law (61/2007) in accordance with the electronic prescription.
Centre for the development of security and in the pharmaceutical sector will maintain and keep an up-to-date list of publicly available on the Internet from legitimate pharmacy network services. Pharmacy network services on the website will have a link to the list maintained by the Centre. In addition, the pharmacy's Web service sites must be clearly visible, in accordance with article 85 (c) of the directive, the European pharmaceutical Union, the common name. Centre for the development of security and in the pharmaceutical sector on the website will be available in the national legislation, which is applicable to the provision of distance marketing of medicinal products over the Internet, including the fact that the classification of medicinal products and the terms of delivery can be differences between the Member States of the European Union. In addition, the website must be the purpose of the common logo, as well as background information on the information to the public with the information society services provided to illegal drugs. (30.12.2013/1200)
Otherwise, the pharmacy's Web service activities shall apply to the extent that the Consumer Protection Act (38/1978) provided for in Chapter 6 of the distance marketing directive. Pharmacy network service shall also apply to the other etäviestimien of drugs for sale. In the pharmaceutical sector for the development of security and can give the content of the notice, as well as the provisions on the conclusion of the activities of the network service, and, on the technical execution of the selection, administration and control of medicinal products.

53 section (2009/773) in the pharmaceutical sector for the development of security and may decide to amend the page apteekiksi pharmacy, the pharmacy licence if the Pharmacy has become open. Centre for the development of safety in the pharmaceutical sector and authorise the marketing of the page, taking into account, in which the pharmacist to pharmacy to his transferring to it the pharmacy location and operating conditions for the necessary conditions for the page to the pharmacy.

54 section (2009/773) in the case referred to in subsection 52 (1) of the article page, the pharmacy's turnover is so high that it is equivalent to at least half the country's private pharmacies, on the basis of the average turnover of pharmaceutical security and development can change the page to the pharmacy apteekiksi.
If a pharmacy is smaller than the page apteekkiaan in terms of net sales in the pharmaceutical sector for the development of security and can grant referred to in subsection 1, in the past the page apteekkina to have worked for the pharmacy's pharmacy licence it to be picked up without declaring to the pharmacy, the page apteekkina it is working.
The decision referred to in subparagraph (1) above, the page apteekiksi is not allowed to do, amending the pharmacy before five years have passed since the page setting up a pharmacy.

Sales of nicotine (13 January 2006/22) 54 (a) section (on 13 January 2006/22) Nicotine products to be sold by way of derogation from article 38 (a) the tobacco store that sells in retail stores, kiosks and petrol stations as well as food service establishments on the basis of the location of the place of sale issued by the vähittäismyyntiluvan. Nicotine products may be sold only to individuals 18 years of age and older. The seller must be able to control the purchase situation. Sales of the automatic sales of the devices is prohibited. (10.12.2010/1112)
The authorization shall be issued at the written request of the nicotine products for sale, provided that the applicant is in a position to maintain and sell nicotine products with this in accordance with the law. The application shall contain the following information: 1 the name of the applicant for, or the community's) name and contact information, business and the community name and the addresses of the places of sale of nicotine products;
2. the storage and sale of products) with a report on the nicotine control arrangements;
3 the name and contact details of the responsible for the sale); and 4) nicotine products at the point of sale, the number of sales outlets and a description of their location.
Nicotine product for retail sale shall be authorised in a request for a licence amendment of the information communicated and the termination of the sale. The granting of authorisation shall be notified of the termination of the sale and the security and development of the pharmaceutical sector. (2009/773), section 54 (b) (13 January 2006/22) in a place other than in pharmacies in pharmacies and medicine cabinets, page nicotine products, warehouse, retail, marketing, Medicine Centre for the development of the field of security and control, and in the field of pharmacovigilance should follow, mutatis mutandis, to the provisions of this act otherwise provides for the storage, sales, pharmaceutical safety and control and the Centre for the development of pharmacovigilance. What is 55 and 55 (a), section 56 and 57 of the sale referred to in this article shall not apply. (2009/773)
Other than in pharmacies in pharmacies and medicine cabinets, page nicotine under the supervision of the retail sale of products must also comply with, what measures to reduce the prevalence of smoking (693/1976) article 14 (4).

Article 54 (c) (13 January 2006/22) shall on their own initiative and on the basis of the verified notifications nicotine storage and sales as well as to control the sale of nicotine products.
If the inspection or otherwise, it is found that the law or are contrary to the provisions adopted pursuant thereto, the following shall be prohibited in the operation of the set, the period within which it is to be stopped.
If the activity has not been corrected within the time limit, or if the procedure is contrary to the provisions referred to in the prohibition extended or if it has been renewed after the expiry of the time, the municipality may cancel the nicotine products vähittäismyyntiluvan.

Article 54 (d) (13 January 2006/22)


The municipality may charge the applicant a fee of nicotine products, vähittäismyyntiluvan vähittäismyyntiluvasta. In addition, the municipality may charge the holder of the control measures relating to the control of the vähittäismyyntiluvan for an annual fee. For the authorisation and supervision of payment of the costs incurred up to the services. Vähittäismyyntilupamaksun and control the payment criteria down further adopted by the taksassa.
In accordance with this section, payments will be charge without a court order and the decision, where applicable, in the order in which the law on taxes and charges ulosottotoimin (367/1961).
(L) the law on taxes and charges ulosottotoimin 367/1961 has been revoked on the implementation of the 706/L:lla taxes and fees in 2007.

54 (e) of section (from August 20, 2010/699) Nicotine products in the retail and the placement of the content of the application for authorisation may provide more detail on the Government's regulation.
Centre for the development of the pharmaceutical sector, security and may order that the retail sale of nicotine products must be accompanied by separate instructions for use. Centre for the development of the pharmaceutical sector, security and, where appropriate, on the content of the provisions of the guidelines.

Miscellaneous provisions section 55 as a pharmacist shall be in its normal customer base the need for a corresponding number of medicines and the medicines and the use of the necessary equipment and supplies, as well as the needs of the side. (22.11.1996/895)
Pharmacy and the pharmacy must be kept open to the page that access to medicines is guaranteed. Apothecary to the opening hours, which shall be notified to the pharmacy is located. (8.3.1993/248)
Of pharmacists is to help ensure that the pharmacist, the pharmacist, the pharmacy service point and the page for the pharmacy's Web service to be provided to the medicines are impeccable and the sale or consumption of medicinal product is the appropriate licence. (10.12.2010/1112) section 55 (a) (a/700) Pharmacies can act within the meaning of article 75 of the Schengen Convention, as competent authorities to issue the certificate referred to in the said article drugs or pharmaceutical products containing psychotropic substances included in the agreement to transport when travelling from one country to another.

56 section (opening/1112) as a pharmacist, and the page as a pharmacist must be needed for pharmaceutical graduate staff. Pharmacists must ensure that sufficient staff is involved in to the pharmacy continuing education. In the context of providing supplementary training must take into account the personnel training and the workplace.
The pharmacy, the pharmacist and pharmacy service point facilities page will be the sale of medicinal products and for storage. For the manufacture of medicinal products and the exploration of the premises used must be suitable for the purpose and properly equipped.

Article 56 (a) (13.12.2013/978), the pharmacy will deliver the second medicinal product for human use in the European Union or in the European economic area or Switzerland medical prescription (European medical prescription), if it is in accordance with European prescription drug may be marketed for human use and veterinary medicinal products directive or on the Community procedures for the authorisation and supervision of use and establishing a European Medicines Agency on the European Parliament and of the Council amending Regulation (EC) No 1782/2003 pursuant to Regulation (EC) No 726/2004 and the prescription complies with this Act and the requirements under the provisions adopted pursuant to it.
A pharmacy may refuse to act on a European prescription of a medicinal product, provided for if there is good reason to doubt the authenticity of the prescription or medical conditions, or if a prescription is unclear or incomplete.
Provided for in subparagraph (1) above shall not apply to medicinal products, which require the medicine subject to special medical prescription as referred to in paragraph 2 of article 71 of the directive.

57 section (opening/1112) Drugs from the Pharmacy and the pharmacy is a pharmacy pharmaceutical personal page of advice and guidance to ensure that the drug user is aware of the safe use of the medicinal product, in the right, and to verify the success of the treatment. In addition to the medicinal product, the buyer must provide information on the prices of medicinal products, and other information relevant to the selection of pharmaceutical products. The price of the medicinal product to be supplied on medical prescription advice should be included in the data at the time of delivery is actually the cheapest medicine. (20.3.2015/253)
L:lla 253/2015 modified the Act shall enter into force on the 1.1.2016. The previous wording is: Drugs from the Pharmacy and the pharmacy is a pharmacy pharmaceutical personal page of advice and guidance to ensure that the user is aware of the medicinal product, in the right of the medicinal product and the safe use of the drug, in order to ensure the success of the treatment. In addition to the medicinal product, the buyer must provide information on the prices of medicinal products, and other information relevant to the selection of pharmaceutical products.
Pharmacy service and pharmacy through medicine belongs to a network service at the University of Helsinki in Pharmacy and apothecary, University pharmacy will take care of it, that the buyer has the opportunity to get a pharmaceutical staff advice and guidance on safe use of medicines and pharmaceutical products, information on the prices and other matters affecting the choice of proprietary medicinal products. On the basis of a medical prescription to the pharmacy service point to be supplied in the drugs may only be transmitted to a pharmacist or pharmacist.
In the pharmaceutical sector for the development of security and can give drugs to pharmacies, the provisions on the procedures for dispensing in pharmacies, pharmacy service point and the page for the pharmacy's Web service.

section 57 (a) (May 21, 2010/435) as a pharmacist and a pharmacy shall be kept for each calendar year a list of Medicine page. The list shall contain the information for the drug and the amount of the drug user or an establishment that the use of the drug is prescribed, and the määrääjästä. The list shall be kept for a period of five years. List must be drawn up and maintained by the Centre for the development of the pharmaceutical sector, security and more.

Article 57 (b) (13 January 2006/22) when informing the doctor, dentist or other health care professional to prescribe the medicinal product the legitimate medicine under the pharmaceutical preparation within the pharmacy needs to be replaced in a publicly available for proprietary medicinal products referred to in article 57 (c) a list of the medicinal product in accordance with vaihtokelpoiseen, which is the difference between the price of the cheapest priced or lowest: 1) to the cost of the product is less than $ 40 to a maximum of EUR 1.50; or 2) of EUR 40 or more expensive product is not more than 2 million.
(May 21, 2010/435) With each other in the excess of the price of medicinal products the cheapest is defined as the time from the first day of each quarter on the basis of the lowest reference price in force for the product or group is made in the preparation of the reference price for the retail price of the lowest of the group to be replaced. (Dec 5, 2008/803)
The Exchange, however, must not make if the drug määrääjä has banned sales on the basis of the prohibition on entry or by medical hoidollisella medicine provision, or if the drug buyer to prohibit sales. Under a medical prescription to the pharmacy will deliver the same product. If, at the same time, prescription delivered medicine several times, however, the purchaser shall have the right to buy the medicinal product, in later times, in accordance with a medical prescription pharmaceutical product. In addition to the medicinal product, the buyer is always entitled at the time of delivery to him is actually the cheapest convertible for the medicinal product to be imported, unless the drug määrääjä not prohibited the exchange of medical or hoidollisin.

57 (c) section (2009/773) Centre for the development of security and in the pharmaceutical sector will be to draw up a list with each other vaihtokelpoisista on pharmaceutical products. The interchange can be defined as medicinal products, active substances and their quantities which are similar and which are biologically equivalent.
The security and the development of the pharmaceutical sector shall be published in the list referred to in paragraph 1 no later than 45 days before the beginning of each quarter.

57 (d) section (5 December 2008/803), the Ministry of Social Affairs and health Decree of may, where appropriate, provide that the holder of the marketing authorisation shall be notified to the excess of the prices of medicinal products for at least 21 days before the first day of each quarter, the Ministry of Social Affairs and health Decree of määrättävälle authority and, as a rule, the price of medicines information for those who like to other parties. In addition, the Ministerial Decree may provide for the authority from the obligation to publish a list of the vaihtokelpoisista of medicinal products and their prices.

section 58 (13 January 2006/22) vähittäismyyntihintana of the medicinal product must be used in accordance with the regulation of the Council of State the price of the drug to be prescribed rate. In accordance with the scale of the price of medicinal products should be based on the holder of the marketing authorisation for a medicinal product in accordance with article 37 (a) to inform the nationwide existing on the basis of the price calculated for the wholesale price of the wholesale price, the sales income and sales tax. The wholesale price is calculated on the basis of the gross margin on an individual medicinal product can be less than the pharmacy fee Act (148/1946), section 2, of the percentage of payment.

What provides, shall not apply to medicinal products which may be sold in the pharmacies in pharmacies and medicine cabinets, page.
The pay rate is, if necessary, be adjusted. Medicinal products The security and the development of the pharmaceutical sector must provide, on an annual basis the Ministry of Social Affairs and health information on the pharmacy sales margin and other medical information relevant to the hire. (2009/773) 58 (a) section (opening/1112) in addition to what is provided for in section 38 (a) the operation of a pharmacy, the Pharmacy and the page as a pharmacist can also change the health and well-being of the promotion and disease prevention-related activities. The purpose of the use of medicinal products must not be redundant.
If your pharmacist or the pharmacist sold more products than drugs page or within the meaning of subparagraph (1), it is also a place for other service activities, sales, or operations will not be detrimental to the delivery of medicines and medicinal products.

59 section Pharmacy permit in the event of death or withdrawal of an authorisation on the same terms as a result of pharmacists pharmacy, the pharmaceutical industry, the amount of the security and the development of the movement of the handle, until the new who pharmacy pharmacies is taken to the pharmacy. Centre for the development of security and in the pharmaceutical sector the number of pharmacy manager also in the case referred to in article 49. Pharmacy hoitajasta is, mutatis mutandis, in effect, what apteekkarista this is required by law. (2009/773)
Pharmacy in the cases referred to in subparagraph (1) may, on its own responsibility to provide only a licensed pharmacist. A licensed pharmacist may, however, be provided to the pharmacy for a maximum of two months at a time.

60 section (a/700) the detailed rules for the application for a licence, as well as a pharmacist and a pharmacy, pharmacist, pharmacy service point and the page Web service, their activities and facilities, pharmacy and the pharmaceutical validation conditions, as well as a pharmacy Manager page on the staff and on the content and amount of training will be given, where appropriate, the Council of State regulation. (10.12.2010/1112)
Centre for the development of security and in the pharmaceutical sector, in addition to the provisions for the storage of medicinal products may provide more accurate examination of the necessary facilities, and, instruments and devices. (2009/773) Chapter 7 Medical Service in hospitals, health centres and social welfare institutions in the hospital pharmacies and pharmaceutical centres 61 § Sairaanhoitopiirissä can be for its operation in the hospital pharmacy. Maintained by the State, the municipalities and the hospital or health centre can be in the hospital pharmacy or medical centre. (a/700)
A medicinal product within the meaning of subparagraph (1) above, the Centre can be set up in addition to the private healthcare Act (152/90) of a service provider to maintain a unit referred to in sairaansijoja and mentally handicapped erityishuollosta (519/77) to the plant, if the number of sairaansijojen within the meaning of this. (8.3.1993/248)
The hospital pharmacy or medical centre can be set up in the security and of the Centre for the development of the pharmaceutical sector. (2009/773)
The hospital pharmacy and medicine centre premises will be suitable for the manufacture of medicinal products, storage of, and exploration. They should also be properly equipped. (a/700)
Applying for authorization, as well as in the hospital pharmacy and medicine centre of the facilities provided for, if necessary, more precisely the State Council regulation. (a/700)
Centre for the development of the pharmaceutical sector, security and the provisions of the hospital may, in addition, to provide more accurate-Pharmacy and pharmaceutical good manufacturing practices, as well as the activities of the Agency, for the storage, manufacture and testing of medicinal products relating to the facilities, tools and equipment. (2009/773) section 62 (22.11.1996/895) or from the hospital pharmacy or medical center can be without prejudice to the provisions of section 61 shall: 1) drugs in the same district on the territory of the community or to the public to be confined to the social-and healthcare units;
2) infectious disease Act (583/1986), article 25 of the vaccines referred to the same or to private individuals or to be limited to the area of social and healthcare services;
3) medicinal products other than those referred to in paragraph 1 in the social and healthcare units and pharmacies in order to secure the necessary medication for an individual patient's circumstances, there is a problem with the availability of medicinal products with the; as well as 4) drugs the use of the peace-keeping forces operating outside of Finland.
(on 13 January 2006/22) Medications may be used in the pharmaceutical sector with the permission of the Centre for the development of security and deliver in the hospital pharmacy and Medicine Center, also private social and healthcare services, with which the municipality or Federation of municipalities have entered into an agreement to purchase the social and health care services, social services and health care planning and the law on the State subsidy (733/1992), section 4, subsection 1, in accordance with paragraph 4, or who are under the law or other State functions. (December 29, 2009/1727)
Centre for the development of the pharmaceutical sector, security and may, for a special reason, grant permission to supply medicinal products to the way from, as well as in accordance with article 14, article 17 of the manufactured and of the transmission of a medicinal product imported in accordance with paragraph 4, the second social and health care facility and a pharmacist. (2009/773)
The safety of the pharmaceutical sector referred to in this article, and considering the Centre for the development of the granting of authorisation is to ensure that access to medicines in the region significantly constrained. Centre for the development of security and in the pharmaceutical sector is the area of the chemists, before granting a permit, that the operation of the grant of the authorization may have an impact on the. The content of the application for authorisation, the authorisation can be used to provide more detail on the Government's regulation. (2009/773), section 63 (2009/773) in the hospital pharmacy and medicine centre shall keep a list of medications and medicinal products in accordance with article 62. The list shall be kept for at least five years. Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on the drawing up of the list and the list of data to be recorded in the and.

64 section in the hospital pharmacy and Medical Center will be a nurse. The nurse is responsible for ensuring that the hospital pharmacy or medicine and the pharmaceutical service of the relevant operating unit is organized on the basis of this law and in accordance with the provisions of the. (on 13 January 2006/22)
Hospital pharmacy manager must be a licensed pharmacist and Medical Center nurse licensed pharmacist or a licensed pharmacist.

section 65 (a/700) the hospital pharmacy and medical center of the hospital or health centre can be handed over free of charge to the sairaansijalta you want to delete, or outpatient to continue uninterrupted patient care to be transferred temporarily to the necessary medicines. The hospital's outpatient clinic or health center's Office did little to justify the treatment to the patient can be sent free of charge to dispose of the necessary drugs, until he can be, taking into account the local conditions, could reasonably be expected to receive them at the pharmacy. The patient may also be disclosed to huumausaineriippuvaisten persons, free of charge, replacement and maintenance of the addiction-treatment necessary for the implementation of the drugs. In respect of the supply of medicinal products, as well as the conditions of use are regulated in more detail in Decree of the Ministry of Social Affairs and health.
In addition, the hospital pharmacy and medicine centre may be handed over to the free of charge, health huoltolain (1326/2010) referred to in section 13 of the public health awareness-raising work and pregnancy prevention counseling and awareness-raising within the meaning of article 26 of the prevention activities and products. The same may be released free of charge to the infectious disease Act (583/1986) section 25 referred to in vaccines as well as social and health care to the customer the fees (734/1992), section 5 of the medicinal products referred to in paragraph 4. (30.12.2010/1340)
In the pharmaceutical sector for the development of security and can give more detailed provisions on the procedures for the transfer of this section. (2009/773) section 66 (2009/773) in the pharmaceutical sector for the development of security and may suspend or withdraw the authorization referred to in article 61, if the hospital pharmacy or medicine centre activity is substantial in the way of this law, the conditions of the permit or contrary to good manufacturing practice for medicinal products or in the drug safety, or seriously harm if section 78 of the provisions adopted on the basis of the measures are not being taken.

66 (a) section (22.11.1996/895) under the provisions of this chapter shall apply to the activities organised by the social welfare and health care planning and the law on the State contribution, unless otherwise provided for by law.

Military pharmacies and medical centres of the prison service (a/700) section 67 (a/700) the armed forces medical service, you can set up a military pharmacies. The establishment of the military pharmacy shall state by means of a Council regulation.
The prison service medical service can be set up in the medicine centers. The prison service medical centre provides more detail on the Government's regulation. (on 13 January 2006/22) in Chapter 8 (26.11.1993/1046) (26.11.1993/1046) Chapter 8 has been repealed L:lla. 26.11.1993/1046 Chapter 9 Control and overall control of General section 76 (2009/773)


Medical care for the overall design, the control and supervision of the Ministry of Social Affairs and health, under the security and development of the pharmaceutical sector.

Article 76 (a) (2009/773) in the pharmaceutical sector for the development of security and will ensure that the medicinal products in accordance with good laboratory practice (GLP) preclinical safety studies are done and give them the approval of the laboratories engaged in the testing laboratory.
In the pharmaceutical sector for the development of security and can be attached to the adoption of the conditions and limitations of the laboratory. More detailed provisions on the procedure for the approval is given to the Ministry of Social Affairs and health.
Laboratory must be notified of material changes in its activities in the security and development of the pharmaceutical sector.
Centre for the development of safety in the pharmaceutical sector and the adoption of the testing laboratory can be cancelled, if the laboratory does not meet the conditions for approval or it does not comply with the conditions set out in the company's activities, restrictions, or regulations.

Checks of section 77 (30.12.2013/1200) the Centre for the development of pharmaceutical safety and must ensure that the medicinal products and pharmaceutical manufacturers, clinical medicine studies the manufacture of advanced therapy medicinal products, the services of an individual patient's use of the services, the manufacture of the contract manufacturers and intelligence analytics, drug safety are carried out by the laboratories, the pharmaceutical wholesale pre-clinical shops, drug dealers, pharmacies, hospital pharmacies, drugstores and the page medical centers, as well as in the military pharmacy are checked as often as necessary for the control of the proper medicine. In addition, the Agency may inspect the pharmacy service point, the pharmacy's online service, the marketing authorisation of a medicinal product by the holder of the registration and clarifying the definition of pharmacovigilance and the premises, as well as manufacturers of excipients used in the manufacture of proprietary medicinal products. Centre for the development of security and in the pharmaceutical sector can make on-the-spot checks, in cooperation with the European Medicines Agency in accordance with the agreed.
Where appropriate, the inspection may be made without prior notice to you. The inspector shall be admitted to all the premises of the Office, which is not used in the pysyväisluonteiseen housing. The inspection shall be accompanied by all the documents requested by the Inspector, which are necessary for the implementation of the audit. In addition, the auditor shall provide free of charge a copy of his requested the necessary documents as well as the implementation of the audit samples of substances and preparations at the separately in detail. The Inspector also has the right to take a picture of the recordings during the inspection.
The inspection must be kept. Before the adoption of the Protocol to the security and development of the pharmaceutical sector must be given the opportunity to give an opinion on the findings of the audit entity. In particular, with regard to the examination of the issues and the detailed content of the examination procedure, as well as the preservation and storage of the minutes and the time provided for by regulation of the Council of State.
In the pharmaceutical sector for the development of security and provide for the medicinal plant and inspected the pharmaceutical wholesale trade good manufacturing practice or good distribution practice certificate, if the outcome of the inspection shows that the factory or wholesaler complies with the good manufacturing practice or with the principles and guidelines of good distribution practice as provided for by the legislation of the European Union. Centre for the development of the pharmaceutical sector is responsible for the safety and good manufacturing practice or good distribution practices of exporting to the European Medicines Agency to maintain the database.

section 77 (a) (2009/773), the holder of the marketing authorisation for the veterinary medicinal product is to be given to the safety of the pharmaceutical sector and at the request of the Centre for the development of advice and guidance, in order to live animals and animal products on measures to monitor certain substances and residues thereof in live animals and animal products and repealing directives 85/358/EEC and 86/469/EEC and decisions 89/187/EEC and 91/664/EEC amending Council Directive 96/23/EC designated the laboratory may be taken pursuant to the provisions of the use of analytical method for detecting residues of veterinary medicinal products.

78 section (a/700) the Inspector may issue orders to remedy any identified deficiencies. As a result of the order in any examination shall, without delay, to take the appropriate measures.

79 section (7.8.2015/1039) article 79 is repealed by L:lla 7.8.2015/1048, which shall enter into force on the 1.1.2016. The previous wording: article 79 (a/700) the inspection referred to in paragraph 77 above, the regulations may not be appealing to the appeal. Order of the tyytymättömällä has the right to security and development in the pharmaceutical sector the requirement of correction of the decision. Order shall be accompanied by instructions to the security and development of the pharmaceutical sector. Such measures as are provided for in the order, despite the adjustment request must be taken. (2009/773)
The requirement in subparagraph (1) above, found the adjustment shall be made in writing within 30 days of the end of the inspection and shall state the name of the author of the complaint: 1);
2), for which an adjustment;
3 the extent to which the adjustment is requested and the provision), which it is required; the reasons for the claim, as well as 4) adjustment.
Be it the author or the author's signed.
The adjustment request must be accompanied by the evidence on which the claim for an adjustment factor to the bottom and which have not been submitted in the past.

Article 80 (opening/1112) in the pharmaceutical sector for the development of security and the cessation of the manufacture of medicinal products for the time being, you can determine if the inspection or otherwise, to the manufacture of medicinal products or of appropriate purposes occurs if section 78 of the provisions adopted on the basis of the measures are not being taken.

section 80 (a) (2009/773) in the pharmaceutical sector for the development of security and may suspend or withdraw the authorisation in the pharmaceutical wholesale trade on if it is substantial in a way which is in violation of this law or of the permit or its otherwise seriously jeopardize or 78 of the pharmacovigilance provisions adopted on the basis of the measures laid down are not being taken.

81 section (as of 4 November 2005/853) section 81 repealed by L:lla of 4 November 2005/853.

81 (a) section (a/700) the Customs supervises the compliance with the law of maahantuontisäännösten.

Pharmacopoeia and medicine list of the 82 section (2009/773) Centre for the development of security and in the pharmaceutical sector shall be fixed at any given time comply with the pharmacopoeia.
Centre for the development of the pharmaceutical sector, security and, where necessary, lay down any supplementary delayed shall be applicable.

83 section (2009/773) and the Centre for the development of the pharmaceutical sector security is every three years, or more often if appropriate confirm the list of medicinal products, which shall be drawn up, taking into account the provisions of article 3 and 5.
To your home country or from abroad gathered wild plants and parts of plants, which is mentioned in the list of medicinal products may each as they are to sell, if the security and development of the pharmaceutical sector is not explicitly denied.
Chapter 10 miscellaneous provisions article 84 (8 May 2009/311) food safety may be imported into the country, distribute, and sell in the prevention or detection of serious animal diseases, immunological veterinary medicinal products referred to in this purpose, if the product is not otherwise available in Finland, or the resistance of diseases in animals, otherwise required to do so. Activities must be in accordance with what the 35 (a) and 36 of the pharmaceutical wholesale trade.

Article 84 a (a/700) in the State of the European economic area, to the person entitled to the veterinary profession gets 17 and without prejudice to the provisions of article 21, the time to bring with them and use in veterinary medicine, which has a marketing authorisation of the medicinal product in the country, where he is mainly engaged in the profession, and which contains the same amount of the same active ingredient as authorised in Finland. The State Council Regulation lays down rules on the import of medicinal products for veterinary conditions, the maximum amount of a medicinal product to be imported, the transfer of the animal to the owner or holder of the medicinal product, as well as the use of the records and documents relating to preservation.

84 (b) section (24 July 2009/595), pharmacies, pharmacy and the University of Helsinki University of Kuopio pharmacy including pharmaceutical manufacturers, wholesale stores and carry out trade in medicines and medicine regarding the control of the audit of the safety of the pharmaceutical sector and the development of two thousandths of the total sales of medicinal products and the difference between the buying-in price (quality control). The sales margin is deducted before the payment to pharmacies, prescription pharmacy. Pharmaceutical manufacturers to make payment on the sale, in which those without the mediation of the supply of the goods directly to the pharmaceutical wholesale trade to the pharmacy or to the rest of the intended purchase.
Centre for the development of security and in the pharmaceutical sector shall be fixed each year by the fee referred to in subparagraph (1) and it has the right to get the information they need, for the purpose of calculating the fee free of charge. In the pharmaceutical sector for the development of security and provide more detailed provisions for a charge to be levied.

Some of the certificates (26.11.1993/1046) 85 section (2009/773)


In the pharmaceutical sector for the development of security and can give drugs to foreign countries for the export of the pharmaceutical laboratories, medicines for clinical medicine research departments, pharmaceutical wholesalers, as well as manufacturing exports, which is the subject of the authorities in the country in the manufacture of medicinal products and their certification.

Clinical drug trials, section 86 (23.4.2004/296) Clinical Medicine Research, for the purposes of this Act, the intervention research on human subjects, which explains the effects of the medicinal product on the human body, as well as the drug absorption, distribution, metabolism or excretion of the human body.

section 87 (2009/773) in the implementation of the clinical studies is to be used, what are the medical research Act (488/1999). In addition, account must be taken of the provisions of this law and on the basis of clinical medicine studies.
Gene therapy, somatic cell therapy medicinal products for the treatment or ksenogeeniseen cell as well as medicinal products containing genetically modified organisms, the start of clinical medicine research requires pharmaceutical security and authorization issued by the Centre for the development of. Other clinical drug studies, prior notification must be given to the Centre.
The survey gets the start after that, when the Ethics Committee has given the medical research Act (3) and 10 (c) referred to in article a favourable opinion and the safety of the pharmaceutical sector-and Development Center has issued a research permit or required by this section it is stated that the research that requires prior notification to the client for the initiation of the investigation, the barrier does not exist, or, if the Center has not made such a declaration, within 60 days of the the Center has received the proper advance notification.
Centre for the development of the pharmaceutical sector in the security and shall take its decision for gene therapy or somatic cell therapy medicinal products containing genetically modified organisms, as well as clinical trial data on the application of the pharmaceutical studies in order to begin within 90 days of the date of receipt of a valid application. The Agency may extend the time limit of 90 days, if required for the adoption of the broad opinion for further clarification. Ksenogeenisista cell research decision does not have a time limit. The decision, however, is to be given without undue delay.
If the security and development of the pharmaceutical sector is not able to accept the application for a permit or notification from FIFA-the request for execution, in accordance with the research is to learn more. Further to a request for clarification is identified and perusteltavat all the reasons, which is why the investigation cannot be completed in accordance with the study plan. The sponsor can be the safety of the pharmaceutical sector and on the basis of the Centre for the development of a request for change in order to remedy the shortcomings described in the research plan. If the applicant does not change the prior statement or the application or request for clarification of the Centre's additional changes are not required, will not be allowed to commence clinical pharmaceutical research.
In the pharmaceutical sector for the development of security and provide more detailed provisions on applying for the authorization referred to in paragraph 2, the contents of the application and of the quality of medicinal products for human use and the prior notification of the preparation, as well as studies on the implementation of the safe and appropriate, of the notification of the adverse effects of significant issues in terms of security and other investigations.

Article 87 (a) (2009/773) If a clinical medicine research in the research plan is amended in such a way that the change may affect the safety or change the study to be examined as aid to the interpretation of the documents used in the scientific, or if the change is significant, the change will be to inform the security and development of the pharmaceutical sector. The study does not, in accordance with the amended plan shall continue until the Ethics Committee has given a favourable opinion on the change and development of security and in the pharmaceutical sector has announced that the continuation of the investigation, in accordance with the amended plan is not prevented or, in the absence of such a declaration is not made, the change notification is passed 35 days.
If the security and development of the pharmaceutical sector do not agree to the amendment to the Protocol, is the sponsor of the study plan for the revision of the necessary changes to be reported. The research is allowed to continue after these and the Ethics Committee may be required changes have been made, or alternatively, in accordance with the original plan of the research must be continued, subject to suspension or removal of a security does not require to be tested for research.

section 87 (b) (2009/773) in the pharmaceutical sector for the development of security and responsible for monitoring clinical drug studies. The Centre shall have the right to inspect notwithstanding the provisions on secrecy, to verify the accuracy of the information collected during the investigation, the relevant factors, including the study of place, research documents and persons to be examined the patient. Such checks shall apply in addition to, what 77, 77 (a) and article 78 to 80.
If the security and development of the pharmaceutical sector has objective grounds for considering that the sponsor, investigator, or other research-related person no longer meets the obligations imposed on it by him, the case may be, shall inform the person concerned of the sponsor, the investigator or any other person and indicating the course of action which the party concerned shall be taken in order to remedy the situation. The Agency shall forthwith inform the Ethics Committee of the plan immediately, as well as of the European Union, the competent authorities of the Member States and the Commission.

section 87 (c) (16 October 2009/773) in the pharmaceutical sector for the development of security and may order the cessation of, or cessation of the research in clinical medicine temporarily, if the research is not carried out in accordance with the study plan, or in accordance with the conditions of the research plan are no longer valid, or if the research does not meet the medical research law or on the basis of the provisions of this law, or their, or comply with the provisions of the conditions.
Before the adoption of the order referred to in subparagraph (1) of the safety and of the Centre for the development of the pharmaceutical sector must be consulted on the contractor or researchers. The sponsor and the investigator shall provide a report within seven days, as requested by the Agency. If the warrant is based is to explore threatening imminent danger, may provisionally suspend the investigation of the Central order immediately. On the basis of a direct risk to be suspended, to terminate the investigation only after the contractor or the contractor, in accordance with the above, has been consulted.
Centre for the development of the pharmaceutical sector in the security and shall inform the Commission of the European Community for the order, the European Medicines Agency and of the States members of the European economic area, the drug responsible for the competent authorities, as well as the relevant ethical committees. The notification shall be accompanied by the reasons for the order.

87 (d) of section (2009/773) in the pharmaceutical sector for the development of security and is responsible for the clinical studies on the submission of data on the European Agency for the evaluation of the Agency to maintain the database. The information stored can be used to adjust the State Council regulation.

88 section (23.4.2004/296) Pharmaceutical Factory, drugs in clinical medicine studies concerning the unit and the pharmaceutical wholesale trade, as well as the pharmacy may be handed over to the clinical medicine research submitted to the doctor and dentist in order to carry out the necessary research.

Article 88 (a) (2009/773) veterinary medicinal products ' tasks in clinical studies, prior notification must be given to the security and development of the pharmaceutical sector. The Centre oversees the clinical veterinary medicine studies and has the right, if necessary, to check the accuracy of the information collected during the investigation, in order to ensure the necessary elements including research place and research documents.
Centre for the development of the pharmaceutical industry for security and can, if necessary, prohibit the commencement of the examination referred to in paragraph 1, if the research does not meet the provisions of this law, or to comply with the provisions of the adopted on the basis of the conditions, or. The Agency may order the cessation of, or to the study of clinical veterinary medicine, where the study temporarily in the implementation of the cessation of the essential flaws or omissions have occurred and these have not been corrected at the behest of the Centre.
Before the adoption of the provision referred to in paragraph 2 to the security and development of the pharmaceutical sector must be consulted on the contractor or researchers. The sponsor and the investigator shall provide a report within seven days, as requested by the Agency. If the warrant is based is to explore the animal for a looming imminent danger, the Centre may order an investigation to be suspended immediately. On the basis of a direct risk to be suspended, to terminate the investigation only after the contractor, or the contractor, in accordance with the laid down above, has been consulted.
Government regulation is necessary in order to provide advance notice of the time referred to in subparagraph (1), as well as the suspension of the investigation procedures and deadlines. In the pharmaceutical sector for the development of security and can give the notification referred to in paragraph 1, the provisions of the research for the quality of medicines, and the safe and proper implementation of the manufacture, research, reporting, and other studies, the adverse effects of significant issues in terms of security.


To disclose information under section 89 (opening/1112) Pharmaceutical Factory, drugs in clinical medicine research unit, manufacturing drugs pre-clinical safety to do the laboratory analysis of the manufacture of medicinal products, the manufacturer of the contract or agreement to perform the unit or laboratory, medicine wholesale, the holder of the marketing authorisation or registration, apothecary, pharmacy of the University of Helsinki, the University of Eastern Finland, pharmacy, hospital pharmacy and Medicine Center, advanced therapy medicinal products, as well as Military manufacturing unit for an individual patient, a pharmacist must, on request, give the medicine in the field of security and the development of the importation of such medicinal products, notwithstanding the the inspection of the manufacture, distribution, pharmaceutical, information relating to the sale or other forms of consumption, disposal and reports which are necessary for the Centre to carry out the functions provided for in this or any other Act.
Drugs in clinical trials, as well as the manufacturing unit of pharmaceutical studies, medical research, section 2 of the law referred to in paragraph 4, the investigator and the sponsor referred to in paragraph 5 shall, on request, give the medicine in the field of security and the development of clinical medicine studies notwithstanding any information and explanations that are necessary for the Center in law and medical research in order to carry out the tasks provided for in the Act.

Article 89 (a) (2009/773) of the Centre for the development of safety in the pharmaceutical sector, and notwithstanding the provisions of the European Community, the Commission must be notified, the European Medicines Agency and of the States members of the European economic area, to the competent control authorities, as well as save the medicinal products of the European Medicines Agency for the supervision of all the databases that are maintained by the drug and the information received in the context of pharmacovigilance, the European Community legislation requires the parties referred to or disclosed by Save nurseries not administered by the European Medicines Agency databases.

89 (b) of section (30.12.2013/1200) in the field of Social Affairs and health for the authorisation and supervision of the Agency, the National Institute for health and welfare, as well as at the request of the institution shall be obliged to provide, free of charge, to the security and development of the pharmaceutical sector in the Act in order to carry out the tasks laid down in the authorisation and supervision of the necessary information and explanations notwithstanding professional secrecy. In the field of Social Affairs and health, the Agency for the authorisation and supervision of medicinal products sector is notwithstanding the provisions on secrecy, security and pyyntöäkin shall inform the Agency of the Centre for the development of a health care professional ammatinharjoittamisoikeuteen the impressive fact that, in accordance with the provisions of this law may have an impact on the validity of the grant or. Notwithstanding the provisions on secrecy, public institution to have the right without the security and development of the pharmaceutical sector pyyntöäkin to inform the Agency on the issues brought to pharmacies and chemists, which may have an impact on the granting of a licence pursuant to this Act or in place.

Professional secrecy article 90 (21 May 1999/679) Pharmacies or his assistant should not be tampered with to express the kind of private or family secret, that he is in Office received the information.
The Act on the openness of government activities (621/1999) without prejudice to the obligation of professional secrecy laid down in the safety and development of the pharmaceutical sector shall be made available, in accordance with the law in carrying out their duties, the information obtained in the business or professional community, private or secret institution of the European Union and the rest of the supervisory authority, as required by the European Community, as well as Elintarviketurvallisuusvirastolle, the Ministry of Social Affairs and health, drug pricing Board, the social insurance institution of Finland, as well as the police, customs authorities and the public prosecutor's Office at the time, when it is necessary for the performance of their statutory duties. (2009/773)

The marketing of medicinal products, section 91 (as of 4 November 2005/853) for purposes of the appropriate use of the medicinal product in the marketing of medicinal products should be encouraged. The information must be in the marketing of the medicinal product, in accordance with the approved summary of product characteristics.
The population of the medicinal product, the marketing of medicinal products may not attract unnecessary, to give an exaggerated impression of the image to be erroneous, or the composition of the preparation, the importance of the origin or lääkkeellisestä or any other similar way inappropriate. A medicinal product may be advertised or marketed only in the law. The marketing of a medicinal product shall be prohibited, which does not have a valid marketing authorisation or registration in Finland.
In addition to what is provided for in paragraph 1 and 2, is valid, what the economy (38/1978) provides for the regulation of the marketing.

91 (a) section (a/700) the population may not be marketed prescription drugs or psychotropic substances to be supplied and not containing medicinal products. In the marketing of the ad must be mentioned against at least the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance, the correct and safe use of the medicinal product in terms of the necessary information, as well as explicit and easily legible invitation to read carefully the use of the medicinal product for instructions. An exception is, however, a reminder of the marketing of proprietary medicinal products. Reminder of the marketing name of the medicinal product, shall be only its international non-proprietary name or trade mark and, in addition, the holder of the marketing authorisation or registration. (as of 4 November 2005/853) is repealed as of 4 November 2005 L:lla/853.
Medicine advertising must not contain unsubstantiated health claims and does not affect the children. Medicine advertising cannot be given exaggerated or misleading picture of the effects of the medicinal product.
The sharing of samples of medicinal products to the population of the promotional is prohibited.

section 91 (b) (a/700) the supply of a medicinal product to persons qualified to prescribe or be marketed also in article 91 (a) medicinal products. This type of marketing is going to happen to the supply of a medicinal product to persons qualified to prescribe or only in the medicine-presentations and printed publications, as well as in electronic media. E-marketing is going to be protected, that it may not be enforceable against third parties.
The supply of a medicinal product to persons qualified to prescribe or advertising must contain the relevant information about the drug and how to use it. An exception is, however, a reminder of the marketing of proprietary medicinal products. Reminder of the marketing name of the medicinal product, shall be only its international non-proprietary name or trade mark and, in addition, the holder of the marketing authorisation or registration. (as of 4 November 2005/853), section 91 (c) (10.12.2010/1112) the holder of the marketing authorisation for the medicinal product or a registration or other drugs for marketing should be considered publicly available an up-to-date list of direct and indirect financial or other support to similar arrangements that it has made in the field of medicine and health care associations and patient organisations.

92 section (23.4.2004/296) of animal health staff and doctors myynninedistämistoiminnan, such as the receipt of benefits of a different kind of medicinal products and gifts, will be the economic significance and join them in their professional activities. Promotional events hospitality must be reasonable and the purpose of the subsidiary to, and must not be extended to other than health care. Activities must not be inappropriate, not its quality, that it can be considered a threat to public confidence in the independence of the prescription of medicinal products, use or disposal. At events for purely professional and scientific purposes of providing hospitality shall always be reasonable in level and secondary in relation to the main scientific objective of the meeting, and must not be extended to persons other than health-care professionals.
Persons qualified to prescribe or supply medicinal products shall not solicit or accept any incentives, benefits or gifts, which is prohibited as provided for in subparagraph (1), or are otherwise contrary to it.

Article 92 (a) (23.4.2004/296) 91-92 of the restrictions provided for in article marketing can be used to provide more detail on the Government's regulation.
Centre for the development of the pharmaceutical sector, security and monitors the adequacy of the marketing of medicinal products. The implementation of the control of the drugs market and advertising should be delivered by the Centre for security and development in the pharmaceutical sector, the State Council regulation adjustable reports and announcements of marketing and advertising. (2009/773)
In the field of Social Affairs and health and the Agency for the authorisation and supervision of local government agencies must ensure that health professionals (559/1994) referred to a health care professional persons qualified to prescribe or supply medicinal products, comply with the prohibitions laid down in article 92. Provides otherwise, the health care professionals who act. (22 December 2009/1546) of section 93 (opening/1112)


If the marketing of the medicinal product has been 91, 91 (a), (b) or under section 91 or 92 of 92 (a) contrary to the provisions laid down pursuant to article, the security and development of the pharmaceutical sector can prohibit the continuation or the operation of the marketing. The Centre may also impose a ban on the infected to submit to marketing, where it is considered necessary, jeopardising drug safety. The Agency may impose under section 91 (c) of the list referred to in the publication deadline.
The ban on the publication of the list and an order to correct or improve the marketing of fine. The effectiveness of the ban or order may, if necessary, set a new penalty.
The threat of a fine or an order of prohibition was laid down in the regional administration office condemns the security and development of the pharmaceutical sector.

93 (a) of section (22 December 2009/1546) the Centre for the development of pharmaceutical safety and may take under section 93 of the measures referred to in paragraph 1 and 2 of the law on the procedure for the cross-border ban (1189/2000), on application by a foreign authority or organization referred to in, if Finnish, of the action is contrary to the advertising of medicinal products for human use amending Council Directive 92/28/EEC, or to the laws of the Member States concerning the pursuit of television broadcasting activities, regulations and on the coordination of certain provisions laid down by the Council Directive 89/552/EEC, the provisions of article 14, as they have been nationally implemented the law to be applied in the future.
The prohibition provided for under paragraph 1, it was the purpose of the periodic penalty payment imposed by the regional administration office condemns the security and development of the pharmaceutical sector, or on application by a foreign authority or organisation.

93 (b) of section (2009/773) in the pharmaceutical sector for the development of the right to security and to initiate action in another State of the European economic area, provides for the prohibition of the Act on the procedure for cross-border exchanges.

section 94 (as of 4 November 2005/853) and of the marketing authorisation for the medicinal product, the holder of the registration must be provided to the scientific service unit, which is responsible for the marketing of medicinal product information.

Section 95 of its curative gas sales (2009/773) by way of derogation from the provisions of this law provides for the sale of pharmaceutical drugs or pharmaceutical wholesale, can the manufacturer or importer of the medical gas upon receipt of the referred to in article 8 or 32 to sell pharmaceutical gas to the patients concerned, as well as the needs of the emergency medical services. In the pharmaceutical sector for the development of security and can give more specific regulations for medical gas delivery practices.

The right to dispose of the veterinary medicines (a/700) 95 95 95 (a) (a) to (c) of section 95 (c) L:lla 16.5.2014/388 article has been repealed.
Chapter 11 penalties and appeals, as well as the delegation of the Penalties under section 96 (conduct/411) penalty for violation of this law or the law of the European Community regulations on the control of medicinal products referred to in this or the legal or regulatory provisions adopted pursuant to the Criminal Code provides for the crime of medicinal (39/1889), Chapter 44, section 5.
The penalty for pharmaceutical wholesale and pharmacy without a permit issued in accordance with this law, the pursuit of the motion provided for in the Penal Code, Chapter 44, section 3.

Article 97 (21.4.1995/643) the penalty for the violation of professional secrecy, provided for in article 90 of the condemnation of the criminal code, chapter 38, section 1 and 2, unless the Act is not punishable under the Penal Code, chapter 40, section 5 of the Act on provision of a heavier penalty, or elsewhere.

Article 98 (23.4.2004/296) which intentionally or recklessly or control of this law, or 308 of the Treaty establishing the European Community on the basis of article 95 of the regulation on the general provision on virtue or on the basis of the case against an order or 1) manufacture, import, store, keep available for sale or transfer in the law on medicinal products, 2) in this Act, the Declaration of medicinal products fail, tietojenantovelvollisuuden or the marketing list , 3) violating the Finnish supervisory authority or of the Commission of the European communities or by the Council of the European Union ban on medicinal products referred to in this Act, the marketing of the medicinal product, in violation of the law of 4), or 5) requests, accepts or receives, section 92 prohibited incentives, benefits or gifts, is to be condemned, as provided by law, unless a more severe penalty in the rest of the work, shall be sentenced to a drug offence.
The drug also condemns the violation intentionally or through negligence, which fails under article 58 medical rate.

99 section 99 (26 October 2001/893) section has been repealed L:lla of 26 October 2001/893.

100 section (conduct/411), the section has been repealed L:lla of conduct for 100/411.

Some of the bans and cancellations (26.11.1993/1046) section 101 (2009/773) Centre for security and development in the pharmaceutical sector have the right to prohibit the importation, manufacture, distribution of the medicinal product and sales, as well as the rest of the supply, if the consumption occurs or there is reason to believe that the conditions for the granting of the marketing authorisation or registration no longer exists, or for the manufacture of the medicinal product or, if the importation requirements and obligations have not been fulfilled.
Security and development in the pharmaceutical sector has the right to control the supply of the medicinal product, the supply of credit ratings and sales and other consumption of medicine to be removed from the market as well, if there is reason to believe that the medicine is fake or a medicinal product is the product of an error. (30.12.2013/1200) section 101 (a) (2009/773) in the pharmaceutical sector for the development of security and can cancel the manufacture of medicinal products or wholesale trade or pursuit of the activity of the authorisation granted, if any claim related to the granting of an authorisation are no longer fulfilled, or if any of the security or the quality of the relevant obligation is not met.

Appeal and error correction in some cases (24.2.1995/416), section 102 (7.8.2015/521), the Centre for the development of safety in the pharmaceutical sector and in Chapter 4 of the decision, 40, 49, 50, 52, 59, 66, 80, 80, 87, 88 (a) (c) (a), 93, 101 and 101 (a) in the case referred to in article on the matter, as well as a pharmacy permit may be appealed by appealing to the Administrative Court as administrative act (586/1996).
Centre for the development of safety in the pharmaceutical sector and the rest of the decision referred to in paragraph 1, as well as a provision referred to in section 78 of the Inspector may require an adjustment to the security and development of the pharmaceutical sector in the Centre as the administrative act (434/2003). The adjustment to the requirement of the decision may be appealed by appealing to the Administrative Court, as administrative law.
The decision of the administrative law section (2), 29, 49, 50, 66, 80, 80, 87, 88 (a) (c) (a), 93, 101 and 101 (a) in the case referred to in article must appeal to as administrative law. The rest of the decision may be appealed only if the Supreme Administrative Court grants leave to appeal.
Centre for security and development in the pharmaceutical sector have the right to appeal against the decision of the administrative law.
Centre for the development of the pharmaceutical sector, security and article 2 (4), 6, 7 (c), 30 l, 30, 59, 66, 80, 80, 87 (c) (a), 87, 88 (a), 93 and 101 in the decisions referred to in the article as well as the auditor's requirements must be observed, in spite of the appeal, unless otherwise required by the appellate authority. The Center's 40, 41, 52 and 54 in accordance with the decisions of the article must not be implemented before they have acquired the force of law.
L:lla 10/15, section 102 amended shall enter into force on the 1.1.2016. The previous wording: article 102 (16 October 2009/773) pharmaceutical security and, on the basis of this law, to the Centre for the development of an appeal is brought against a decision by the administrative act (586/1996). The administrative court decision, which is resolved in the 40, 41, 52 or 54, paragraph thing, may be appealed in the Supreme Administrative Court only if the Supreme Administrative Court grants leave to appeal. The decision of the administrative law, which concerns the obligation to disclose information referred to in article 89, may not be appealed.
Leave to appeal may be granted if: 1 the application of the laws of the other similar) cases, or the consistency of the case-law is important, therefore, to refer the case to the Supreme Administrative Court;
2) referred to the case of the Supreme Administrative Court has a special topic issue of manifest error; or 3 the granting of leave to appeal is not heavy) reason.
Security and development in the pharmaceutical sector also has the right to appeal against any administrative decision, the right to appeal if the Administrative Court in answer to the appeal of the case.
Centre for the development of safety in the pharmaceutical sector and 2 of section 30 (c), 23, n, 66, 59, 80, 80, 87 (c) (a), 87, 88 (a), 93 and 101 in the decisions referred to in the article is to be followed, in spite of the appeal, unless otherwise required by the appellate authority. The Center's 40, 41, 52 and 54 in accordance with the decisions of the article must not be implemented before they have acquired the force of law. (3.5.2013/330)

Notwithstanding the provisions of the administrative act (434/2003) provides for the correction of a material error, the safety of the pharmaceutical sector and for the development of the proprietary medicinal product may be removing the granting of a marketing authorisation, amendment and withdrawal of the authorisation of the medicinal or drug consumption, a ban on the transfer of its decision and the matter again, if in the case referred to above, the European Union's institutions by the decision.

section 102 (a) (7.8.2015/10) Notwithstanding the provisions of the Act provides for the correction of a material error, the Management Board, the Centre for the development of the pharmaceutical sector in the security and the granting of a marketing authorisation for the medicinal may delete, change and cancellation of the permit of the proprietary medicinal product or a ban on the consumption of the medicinal product, its decision on the extradition of, and the right to resolve the issue, if the European Union's institutions by the decision referred to above.
L:lla 10/15, section 102 (a) shall enter into force on the 1.1.2016 added.

Regulation Authority under section 103 (a/700) the detailed provisions on the implementation of this law, shall be provided to the State by means of a Council regulation.
Chapter 12 of the entry into force and transitional provisions article 104 of the entry into force of this law shall enter into force on 1 January 1988.
This Act repeals the pharmacy of the establishment of the law of 4 January 1928 (4/28) and 5 December 1935 of the Pharmacy Department of law (374/35), as amended.
Before the entry into force of the law for the implementation of the necessary measures can be taken.

The law existing at the time of entry into force of the rights and permissions section For which this Law 105 at the time of entry into force is authorised to prepare the goods for sale to the pharmacy or the means to carry on the pharmacy, they have conducted trading of goods has the right to continue without the permission of the industrial manufactured medicinal products laid down in this law, the medicine factory or engage in wholesale trade. This law referred to in article 8 and 32 new permission is, however, to apply for the entry into force of this law, within three years, otherwise the former permit shall be deemed withdrawn.

Section 106 As at the date of entry into force of this law, which is the right to carry out the movement as a pharmacist or a pharmacy, the pharmacy is still the same.

section 107 or kuntainliitolla, which is the date of entry into force of this Act, the licence issued by the Council of State ylläpitämässään in the hospital to keep a particular pharmacy, shall be referred to in this law, the right to a permit is still in the hospital pharmacy. Or kuntainliitto at the time of entry into force of this law, which is ylläpitämässään in a hospital or health centre pharmacy in accordance with the law on the establishment permit otherwise, prepare and distribute medications, can continue, and notwithstanding the provisions of this Act is the medicine's caregiver eligibility conditions laid down in this law, to share the drugs referred to in the Medical Center. Private sairaanhoitolaitos and kehitysvammaislaitos, which is the date of entry into force of this law, the foregoing license to manufacture and distribute drugs, distribute drugs can still be referred to in this law, the medicine.

section 108, the sale or otherwise of the pharmaceutical erikoisvalmistetta release for consumption under the law on pharmacy/authorisation is in force on the entry into force of this Act, may continue to sell or otherwise dispose of the consumption of this law, within the meaning of article 20 of the medicinal product. Otherwise, such a preparation shall also apply to the provisions of this Act.

section 109 Of the sale or consumption of products with the release of the Pharmacy Department of the law in accordance with article 10 (f) the authorisation is valid until the entry into force of this law, and for the products for which the specified purpose of use of the medicinal product concerned is authorised, of the population for the purposes of this Act may continue to be sold as a medicinal product.

At the time of entry into force of the laws of the existing Pharmacopoeia and pharmaceutical inventory, pay rate, section 110 of this Act, upon the entry into force of the bilateral agreements and shall be applicable to the pay rate of the last fixed in pharmacies continue to be complied with, until this law is established by the new medicine and Pharmacopoeia, the pay rate. The Medical Board at the entry into force of this Act not later than within one year to strengthen the drug list, which is in force, the law intended to list/pharmacy pharmacy.

at the time of entry into force of this law, article 111 of the County Government, the lääkintöhallituksessa or the Ministry of Social Affairs and health pending the institution of law or pharmacy/pharmaceutical law, the case will be referred to and resolved in accordance with the provisions in force at the time of entry into force of the law. THEY 87/86, tvk. Mrs. 13/86, svk. Mrs. 272/86 acts entry into force and application in time: 17.1.1991/81: this law shall enter into force on 1 March 1991.
THEY are 233/90, sosvk. bet. 44/90, svk. Mrs. 3508/92/227/90 1167: this law shall enter into force on the date decreed.
At the time of entry into force of the laws of the Social Affairs and health on the Board of the pending cases are heard and resolved in accordance with the provisions in force at the time of entry into force of the laws, with the exception of article 21, paragraph 4 of rule as well as the provision of article 26, which States that the sales price of the authorised product on the market shall submit an application to the Government for health and Social Affairs.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY 118/92, Shub 30/92, 5/92 SuVM 8.3.1993/248: this law shall enter into force on 15 March 1993.
THEY 374/92, 12 November 1993, 1/93/Shub 939: this law shall enter into force on 1 January 1994.
Before the entry into force of this law may be to take the measures needed to implement it.
THEY 171/93, Shub 26.11.1993/1046 19/93:1. This law shall enter into force on the date decreed.
2. the purpose of this law amending the law on medicinal products law of 27 November 1992 (1162/92).
3. at the date of entry into force of the laws of the pharmaceutical plant in the pending cases are heard and resolved in accordance with the provisions in force at the time of entry into force of the laws, with the exception of section 21 of the regulations and of paragraph 4 of article 26 of the provision, according to which the price of the product which has been authorised on the market shall submit an application to the institution, as well as the provisions laid down in Chapter 8 of the medicinal products.
4. this law, article 21 (a) and (2) of which satisfy the requirements of homeopathic and anthroposophic preparations, the sale or any other consumption of which extradition under section 69 or the Pharmacy Department under article 10 of the law, the authorisation granted shall be valid upon the entry into force of this law, shall be entered at the time of entry into force of the laws of the law as referred to in article 21 (a) registered.
5. Other than as set out above, the sale or any other such products for consumption for under section 69 or the Pharmacy Department under article 10 of the law, the authorisation granted shall be valid upon the entry into force of this law, as well as those preparations, which, as it is specifically provided, is approved for the intended use of the medicinal product concerned, be recorded in the marketing authorisation at the time of entry into force of the law this law being section 21 (2) of the approved uses for the products as referred to in rohdosvalmisteiksi.
6. in accordance with the above, the presence of the marketing authorisation for products registered or labelling of products is to bring into force within two years of the date of the entry into force of the law to respond to the medical section (a) and 21 of the 30 's, as well as drug regulation under section 30 of the regulations.
7. Notwithstanding the provisions of section 24 (1) of the Act provides to the validity of the marketing authorisation for the renewal of the marketing authorisation for a medicinal product and the amount of time, the institution, within which, in accordance with the above, the herbal preparations which have been authorised by the marketing authorisation holders must apply for a renewal of the authorization.
8. The aforementioned herbal supplements and homeopathic and antroposofisia products for the industrial manufacturing in Finland is within one year of the entry into force of this law to do medicine institution referred to in article 8 of the law of medicine permit application.
9. The aforementioned herbal preparations within one year of the entry into force of the law in the wholesale traders is the result of apply for the medicine from the authorisation referred to in article 32 or recognition.
10. Before the entry into force of this law may be to take the measures needed to implement it.
Annex II to the EEA Agreement, Council directives (65/65/EEC, 75/318/EEC and 75/319/EEC, 87/21/EEC, 81/851/EEC, 81/852/EEC, 85/432/EEC and Directive 91/356/EEC), THEY'RE 101/93, 29/93 of 24 March 1995/416 Shub: this law shall enter into force on 1 April 1995.
Before the entry into force of this law may be to take the measures needed to implement it.
THEY 337/94, 52/94, Shub Council Regulation (EEC) No 2377/90 2309/93; OJ No l L 214, 24.8.1993, p. 1, Council Directive 93/39/EEC; OJ; No 1782/2003 L 214, 24.8.1993, p. 22, 93/40/EEC OJ No L 214, 24.8.1993, p. 31, 81/851/EEC; OJ No l L 317, 6.11.1981, p. 1 21.4.1995/643: this law shall enter into force on 1 September 1995.
THEY'RE 94/93, SuVM LaVM 22/94, 10/94.1989/282: this law shall enter into force on 1 May 1996 and shall remain in force until 31 December 1996.
By way of derogation from the law of the State share of what (688/92) article 4 and article 6 (1) of the Act provides, the municipal social welfare and health care units of the 1996 State of the entry into force of this Act shall be increased by the municipalities by the total amount of the additional costs incurred.
THEY'RE 13/96, Shub 5/96, 35/96 of 22.11.1996 EV/895: this law shall enter into force on 1 January 1997.

The pharmacy's customer service area and pharmacy permits drug pursuant to section 43 (3) of the conditions attached to the authorisation of the pharmacy belongs to the obligation to keep the page from the pharmacy, shall cease to apply at the latest three years after the entry into force of this law this law determines the pharmaceutical plant in the area referred to in article 40, that the pharmacy will be located. If the medicinal product of law 43 the condition referred to in section is connected to the pharmacy the pharmacy licence, in the solo condition shall cease to be valid at the date of entry into force of this law.
Before the entry into force of this law may be to take the measures needed to implement it.
THEY 118/1996, Shub 19/1996, EV/96, 129 of the Council Directive 83/189/EEC; OJ No l L 109, 26.4.1983, p. 8. 88/182/EEC; OJ No l L 81, 26.3.1988, p. 75, other. 94/10/EC; OJ No l L 100, 19.4.1994, p. 30 22.11.1996/898: this law shall enter into force on 1 January 1997 and shall remain in force until 31 December 1998. (11.12.1997/1135)
By way of derogation from the law of the State share (11/96) in Chapter 2, the municipal social welfare and health-care shares increased between 1997 and 1998, the entry into force of this law the State to the municipalities by the total amount of the additional costs incurred. (11.12.1997/1135)
THEY 167/1996, Shub 25/1996, EV 143/1996 21.11.1997/999: this law shall enter into force on 1 March 1998.
THEY 124/1997, Shub 15/1997, EV 129/1997 11.12.1997/1136: this law shall enter into force on 1 January 1998.
THEY are 175/1997, Shub 25/1997, EV 198/1997 11.12.1997/11: this law shall enter into force on 1 January 1998.
THEY are 175/1997, Shub 25/1997, EV 198/1997 at/420: this law shall enter into force on 1 April 1999.
Before the entry into force of the law can be used to take the measures needed to implement it.
The University of Helsinki will be the University of Kuopio, Kuopio page apteekkinsa to hand over, no later than the entry into force of this law, in six months ' time. The terms of the transfer, on the basis of an agreement between the universities depend on. If the contract has not been concluded by the date of the supply, the amount of the donation of the State Council.
The University of Helsinki will grant the authorisation of medicinal plant to set up a University page for the pharmacy's replacement new 16th page pharmacy no later than six months after the date on which the University of Kuopio, Kuopio page pharmacy has been released. The establishment of the page as the seat of the pharmacy shall prescribe a drug for a legitimate area of Espoo, Helsinki or Vantaa.
THEY 276/1998, Shub 42/1998, 21 May 1999, 308/1998/679 EV: this law shall enter into force on 1 December 1999.
THEY'RE 30/1998 31/1998, EV, HaVM 303/1998 21.12.2000/1191: this law shall enter into force on 1 January 2001.
THEY 178/2000, TaVM 36/2000 EV 183/2000 of the European Parliament and of the Council Directive 98/27/EC (31998L0027); OJ No l L 166, 11.6.1998, p. 51 26 October 2001/893: this law shall enter into force on 1 January 2002.
THEY'RE 80/2000, LaVM 14/2001, EV 94/2001/411 of conduct: this law shall enter into force on 1 September 2002.
THEY LaVM 5/17/2001, 2002/35/2002 a, EV 700: this law shall enter into force on 1 January 2003.
This Act repealed the right to dispose of the veterinary medicines for veterinary regulation of 23 December 1987 (11/87), as amended.
Before the entry into force of the law can be used to take the measures needed to implement it.
THEY'RE 46/2002, Shub 14/2002, 11 December 2002, 91/2002/1190 EV: this law shall enter into force on 1 March 2003.
THEY 146/2002, Shub, 32/2002 of 31 January 2003/166/2002, EV 80: this law shall enter into force on 1 April 2003.
Before the entry into force of the law can be used to take the measures needed to implement it. Upon delivery of a drug to the entry into force of the laws on the prescription before the medicine will be exchanged in accordance with article 57 (b), if the buyer wants to switch to a cheaper, that the pharmaceutical product. The medicinal product, the buyer must notify the Exchange in accordance with article 57 of the possibility of such damages.
THEY'RE 165/2002, Shub 39/2002, EV 209/2002 23.4.2004/296: this law shall enter into force on 1 May 2004.
The provisions of this Act, if applicable, at the date of entry into force of the law to be followed pending clinical medicine research.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 20/2004, Shub 5/2004, EV 33/2004 of the European Parliament and of the Council Directive 2001/20/EC (32001L0020); OJ No l L 121, 1.5.2001, p. 34-44 of the European Parliament and of the Council Directive 2001/83/EC (32001L0083); OJ No l L 311, 28.11.2001 p. 67-128 as of 4 November 2005/853: this law shall enter into force on 7 November 2005. Article 17 of the law, however, will enter into force on 1 June 2006. The provisions of this Act apply to all licensing, registration, applications for change and reform, which is of 30 October 2005 or after.
Before the entry into force of the law can be used to take the measures needed to implement it.
Before the entry into force of this law the proprietary medicinal product which has been authorised, the marketing authorisation shall renew this in accordance with the law. If a marketing authorisation will expire within six months of the entry into force of this Act, an application for renewal may be made under section 24 of the Act, however, the deadline, at least three months before the marketing authorisation ceases to be valid. If at the date of entry into force of this law, a valid marketing authorisation shall be renewed on one or more occasions prior to the entry into force of the law, the provisions of such a reform of the pharmaceutical plant to provide separate reports, which shall be annexed to the application and the documents.
If the proprietary medicinal product, which is referred to in article 5 (a) of the definition of a traditional herbal medicinal product at the time of entry into force of this law, is a valid marketing authorisation, the marketing authorisation of medicinal plant will change it in line with the reform of the registration. If you fall within the definition of article 5 (a) the medicinal product has been classified as fit for human consumption before the entry into force of this law, the application for registration is the product no later than 31 December 2007. If registration has been applied for by the date mentioned in the subsection referred to in article 16A(1) of this traditional, sold without registration until the Agency has made its decision on the application. Medicinal has been granted a marketing authorisation under rohdosvalmisteena, but which is not referred to in article 5 (a) of a traditional herbal medicinal product, in accordance with this law will need to apply for a renewal of the marketing authorisation in force at the time of entry into force of the law.
A well-established medicinal use gas, which is on sale at the time of entry into force of this law and which does not have a marketing authorisation, the marketing authorisation shall apply by 31 December 2007 at the latest. If a marketing authorisation has been applied for by the date mentioned, not pharmaceutical gas to sell without a marketing authorisation, until the Agency has made its decision on the application. Pharmaceutical service may, however, prohibit the medical gas sales the medicine on the grounds referred to in article 101 of the law before a decision on the application for a marketing authorisation has been issued.
If the European Community has granted the marketing authorisation for the medicinal product for which marketing authorisation application is made before or on 19 November 2005, at 21 (a) the amount referred to in subparagraph (1) of section in addition to the 10 years. The entry into force of this law on the other before the application for marketing authorisation in respect of a time limit is based on the comparison of products for six years. If the reference of the product is the subject of an application for a marketing authorization before the entry into force of this law, a marketing authorisation of the generic product does not apply (a) in section 2-4.
If the medicinal product is authorised before the entry into force of this law, shall be calculated under section 29, in accordance with paragraph 3, the time limit of three years from the entry into force of this law.
Veterinary and Food Research Institute, the National Institute for health and the Finnish Red Cross allowed to import, manufacture and distribute drugs at the time of entry into force of this law, in accordance with the provisions in force until the end of 2007. After the importation, manufacture and distribution of medicinal products require a permit issued in accordance with this Act of them. Veterinary and Food Research Institute, public health Institute and the importation of medicinal products by the Finnish Red Cross, after the entry into force of the law on the manufacture and distribution are controlled in accordance with section 77.
THEY are 108/2005 on the PeVL 33/2005, Shub 17/2005, EV 124/2005 of the European Parliament and of the Council Directive 2001/82/EC (32001L0082); OJ No l L 311, 6.11.2001, p. 1, the European Parliament and Council Directive 2001/83/EC (32001L0083); OJ No l L 311, 6.11.2001, p. 67, the European Parliament and of the Council Directive 2004/24/EC (32004L0024); OJ No l L 136, 31 March 2004, p. 85, of the European Parliament and of the Council Directive 2004/27/EC (32004L0027); OJ No l L 136, 31 March 2004, p. 34, the European Parliament and of the Council Directive 2004/28/EC (32004L0028); OJ No l L 136, 31 March 2004, p. 58 on 13 January 2006/22: this law shall enter into force on 1 February 2006.
Before the entry into force of the law can be used to take the necessary steps for its implementation.
37 (a) of this article shall apply to the legal dispensaries of medicinal products to be delivered after the entry into force of the law. Before the entry into force of the agreement is based on the law and to the provision of article 37 (a) medicinal products shall, however, continue to apply after the entry into force of the law in six months ' time.

If the drug product is a marketing authorisation which has been granted prior to the entry into force of this law and the marketing authorisation holder to submit the drug to the institution within four months of the date of entry into force of this Act under section 57 (c) the Declaration referred to in paragraph 3, the first subparagraph of article 57 (c) referred to in paragraph 1 to the validity of the patent or supplementary protection certificate, not an vaihtokelpoiseksi inventory or product and the generic may be defined as the interchange of the patent and the supplementary protection certificate is in effect. Of the same preparations can be brought about by the various proprietary medicinal product importers, however, define the interchange between the validity of the patent or supplementary protection certificate.
If the proprietary medicinal products and generic drugs at the time of the entry into force of this law, is defined in the interchange will be the excess of the pharmaceutical plant to remove the products from the list of the products, if the marketing authorisation holder to submit, within four months from the date of entry into force of this Act under section 57 (c) pursuant to paragraph 3 of the report. The removal must be done in drawing up a report on the patent or supplementary protection certificate to do the following with each other in the excess of a list of medicinal products. Of the same preparations can be brought about by the various proprietary medicinal product importers, however, define the interchange between the validity of the patent or supplementary protection certificate.
THEY'RE 107/2005, Shub, 32/2005, EV 196/2005 28 April 2006/298: this law shall enter into force on 1 May 2006.
THEY 203/2005, MmVM 2/2006, EV 31/2006 February 2nd 2007/62: this law shall enter into force on 1 April 2007.
Before the entry into force of the law can be used to take the measures needed to implement it.
THEY'RE 250/2006, Shub 43/2006, EV 5 December 2008/803 216/2006: this law shall enter into force on 1 April 2009.
Agency publishes the list come into force on 1 April 2009, the vaihtokelpoisista pharmaceutical products by 30 January 2009.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 100/2008, Shub 24/2008, 8 May 2009/138/2008 EV 3: this law shall enter into force on 18 May 2009. Article 15 (c) of the law, however, will enter into force on 1 January 2010.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 21/8/2009, 2009, Shub EV 32/2009 of the European Parliament and of the Council Regulation (EC) No 1782/2003 1394/2007 (32007R1394); OJ No l L 324, on 10 December 2007, p. 121, of the European Parliament and of the Council Directive 2008/97/EC; (32008L0097); OJ No l L 318, 24 July 2009/595, born 28 November 2008 9: this law shall enter into force on 1 November 2009.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY are 74/21/2009, 2009, Shub EV 96/2009, 2009/773: this law shall enter into force on 1 November 2009. Article 15 (c) of the law, however, will enter into force on 1 January 2010.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 166/2009 28/2009, Shub, 22 December 2009/122/2009 EV 1546: this law shall enter into force on 1 January 2010.
Before the entry into force of this law may be to take the measures needed to implement the law.
THEY 161/2009, HaVM 18/2009, by EV 205/2009/1727: this law shall enter into force on 1 January 2010.
THEY'RE 174/2009, HaVM 19/2009, EV 223/2009 may 21, 2010/4: this law shall enter into force on 1 July 2010.
Before the entry into force of this law may be to take the measures needed to implement the law.
THEY 283/2009, Shub 2/2010, the EV 2010-20 August 2010/32 699: this law shall enter into force on 1 October 2010.
Before the entry into force of this law may be to take the measures needed to implement the law.
THEY are 180/2009, Shub 14/2010, EV 102/2010 opening/1112: this law shall enter into force on 1 February 2011.
Before the date of the entry into force of the law to come to the permit applications are processed in accordance with the provisions in force at the time of entry into force of the law.
Before the entry into force of this law shall continue to apply to licences issued in the medicine cabinet. This law enters into force, the medicine cabinet, no authorization can no longer regenerate. Pharmacies, which is authorized to the medicine cabinet, may, however, apply for the safety of the pharmaceutical sector-and Development Center in the medicine cabinet with the permission of the licence authorisations granted to the replacement of the pharmacy service point, if a pharmacy service point, the requirements laid down in article 52 (a) are met. If pharmacies will change, if they so wish, to set up a new apothecary is a pharmacy service point apply article 52 (a) mentioned in the permit.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 94/2010, Shub 22/2010, EV 144/2010 30.12.2010/1340: this law shall enter into force on 1 May 2011.
Before the entry into force of this law may be to take the measures needed to implement it.
THEY'RE 90/2010, Shub 40/2010 therefore, EV 244/2010/662: this law shall enter into force on 1 may 2012.
THEY 199/2010, YmVM 23/2010 on the PeVL 58/2010, 30/35, 2010, HaVL TaVL/2010, EV 360/2010 3.5.2013/330: this law shall enter into force on 1 June 2013.
Before the entry into force of this law the registered or authorised the renewal of marketing authorisation for a medicinal product falling within the scope of this law.
Sales permits and registrations, which are issued before 21 July 2012, must contain the information set out in paragraph (d) requires that the database file from the date of renewal of the marketing authorisation or registration or the date of July 21, 2015, whichever is the earlier.
Centre for the development of the pharmaceutical sector, security and may, by decision, impose on the holder of the marketing authorisation or registration, that is to be introduced, paragraph 30 (d) risk management system also a medicinal has been granted a marketing authorisation or registration before 21 July 2012. Is subject to the condition that the Centre suspects to be risks that affect the sales of proprietary medicinal products authorised or registered in the risk-benefit ratio. The holder of the marketing authorisation or registration in that case, submit to the Agency a detailed description of the risk management system, which it plans to introduce. At the time of the decision followed in the procedure shall be governed by article 23 (c) and 5. The decision must comply with the appeals, unless otherwise required by the appellate authority.
Centre for the development of safety in the pharmaceutical sector and can provide more detailed provisions on fixed-term contracts, as referred to in article 30 (k) submission of periodic safety update reports, if the marketing authorisation or registration has been issued before 21 July 2012 and is kind of a marketing authorisation or registration that has been granted only in Finland, and it has been confirmed by the Union's reference date.
Centre for the development of security and in the pharmaceutical sector, must be examined and assessed in accordance with article 30 (b) of the pharmacovigilance system and report the results to the European Commission, for the first time not later than 21 September 2013.
Before the entry into force of the law can be taken in the implementation of the law.
THEY'RE 200/3/2013, 2012, Shub EV 23/2013, the European Parliament and of the Council directive 2010/84/EU (32010L0084); OJ L 348, 31 December 2010, p. 74-99 13.12.2013/978: this law shall enter into force on 1 January 2014.
THEY 155/17/2013, 2013, Shub EV 134/13 30.12.2013/1200: this law shall enter into force on 1 January 2014.
THEY 183/30/2013, 2013, Shub EV 206 16.5.2014/388/2013: this law shall enter into force on 1 December 2014.
THEY'RE 98/2013/2014, EV, MmVM 3 16/2014 20.3.2015/253: this law shall enter into force on the 1 January 2016.
THEY are Shub 43/330/2014, 2014, EV 292/2014 7.8.2015/10: this law shall enter into force on the 1 January 2016.
On appeal before the entry into force of this law shall apply to the Management Board on the date of entry into force of this law, the provisions in force.
THEY'RE 230/26/2014 2014, LaVM, EV 319/2014