Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The purpose of this law is to maintain and promote the safety of medicinal products and their use and the appropriate use of medicinal products. The purpose of the law is also to ensure the proper manufacture and availability of medicinal products in the country.
This law applies to medicinal products, to the manufacture, import, distribution, distribution and sale of medicinal products and other forms of consumption, pharmaceutical companies, pharmaceutical wholesalers, pharmaceutical wholesalers and pharmacies, medicinal products, pharmaceutical wholesalers and pharmacies. Laboratories carrying out pre-clinical safety investigations and the manufacture and distribution of medicinal products in hospitals and health centres. (30.12.2013/1200)
This law also provides for the marketing authorisation and registration of the medicinal product and other controls on the activities referred to in paragraph 1. (41,2005/853)
The provisions of this Act shall not apply to preparations which are used only for the treatment of parasites, fungal or bacterial diseases of the aquarium fish, and not only in the case of wild birds, terraarioanimals or small rodents. Article 55 (1) shall not apply to homeopathic products referred to in Article 22a. (41,2005/853)
The provisions on the authorisation of this law, modification of the medicinal product, fees related to the marketing authorisation, withdrawal of the marketing authorisation and the marketing of a medicinal product are not subject to the provisions of the Marketing Authorisation The European Medicines Agency or the Commission of the European Communities or the Council of the European Union ( European Union institution ) As provided for in the European Community acts. Where, as a matter of urgency, the protection of human or animal health or the environment is urgently required, the Agency may provisionally prohibit the release of the medicinal product until the European Union institution: You've solved it. The fees and charges related to the import and control of medicinal products referred to in this paragraph may be laid down by a decree of the Ministry of Social Affairs and Health. The amount of the fee is determined by the amount of the contribution by the State (150/1992) Provides. The Centre for the Safety and Development of the Medicinal Products may provide more detailed provisions on the trade and control of the medicinal products referred to in this paragraph, in so far as it is not provided for in the acts or powers of the European Community The European institutions. (16/10/2009)
On the medicine Means a preparation or a substance which, if used internally or externally, is intended to improve, alleviate or prevent the disease or its symptoms in humans or animals.
A substance or a combination of substances which may be used for the purpose of restoring, correcting or modifying human or animal life functions, or a combination of substances or substances, may also be considered as medicinal products. Or in order to determine the cause of health or illness.
In the case of doubt, where the product is capable of meeting the definition of a medicinal product and any other product in other legislation or acts of the European Union, the product may, in the light of its characteristics, be applied in the first place of the medicinal product: Provided.
Falsified medicinal products Means a medicinal product for which, as a result of an unintentional error of quality, it is misrepresented:
(1) any identification of a medicinal product:
(a) labelling and packaging characteristics;
(b) name of the medicinal product;
(c) the composition of the medicinal product containing all ingredients and other ingredients of the medicinal product which are not medicinal products or packaging materials;
(d) the strength of any component of the medicinal product;
(2) the origin, the manufacturer, the country of manufacture, the country of origin or the marketing authorisation holder; or
(3) the product history of the medicinal product, including the materials and documents relating to the distribution channels used.
For the purposes of medicinal products:
(1) manufactured or imported in accordance with this law; and
(2) is intended for use as a medicinal product; and
3) which is sold or otherwise released for consumption in the packaging.
(26.11.1993/1046)A blood plasma derived from human origin is also considered to be used in the preparation of an industrial process. (41,2005/853)
The substance, chemically or otherwise, is defined in detail by the scientific method of the active substance used in the manufacture of the medicinal product or as a medicine as such.
With a traditional herbal medicinal product Means a medicinal product intended for human use containing, as active substances, one or more herbal substances, one or more herbal medicinal products or combinations thereof, and which fulfils the conditions laid down in Article 22 (1) Conditions for registration. In addition, a traditional herbal medicinal product may contain vitamins or minerals if they contribute to the effect of herbal active substances.
Homeopathic medicinal product Medicinal product obtained from homeopathic stocks in accordance with the homeopathic manufacturing procedure described in the pharmacopoeias officially used in the Member States, as described in the pharmacopoeia of the European Pharmacopoeia. A homeopathic product may be made from more homeopathic stocks.
The provisions on homeopathic medicinal products shall also apply to other preparations made with homeopathic methods in accordance with paragraph 1.
Reference product Referred to in Article 21 of Directive 2001 /82/EC of the European Parliament and of the Council of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, Below Directive on veterinary medicines , Article 5 of Directive 2001 /83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, hereinafter referred to as: The pharmaceutical directive , a marketing authorisation under Article 8, or for which the European Union has granted a marketing authorisation. (10.12.2010/1112)
Parallel preparation Means a medicinal product which, in terms of the quality and quantity of active substances, has a similar formulation with the same pharmaceutical form and whose bioequivalence with the reference product has been shown to be bioavailability; In the relevant investigations. The different salts of the active substance, esters, ethers, isomers, mixtures of isomers, complexes and derivatives shall be considered as the same active substance, unless there is a significant difference in their safety or efficacy characteristics. The applicant for marketing authorisation shall provide the necessary additional information to demonstrate the safety or efficacy of the various salts, esters or derivatives of the active substance. A variety of oral medicinal products that are immediately released from the medicinal product are considered as the same pharmaceutical form. Studies on bioavailability need not be conducted if the applicant in the marketing authorisation demonstrates that the generic product meets the criteria set out in the detailed guidelines adopted by the European Commission.
With a medicated gas The use of a gas or a gas mixture, the use of which is based on a pharmacological effect intended for administration to the patient for therapeutic, diagnostic or preventive purposes, and which is manufactured and checked for the good In accordance with production methods.
Excipient Means all ingredients of the medicinal product that are not medicinal products or packaging materials.
Where appropriate, the Agency shall decide whether the substance or preparation is to be treated as a medicinal product, as a traditional herbal medicinal product or as a homeopathic medicinal product.
For medicinal products covered by this Law, which (3703/2008) In addition, there are drugs, in addition to which they are laid down in that law.
In addition to what is laid down in this Act, alcohol-containing medicinal products are regulated by alcohol (1143/1994) And under it.
The compulsory storage of medicinal products is laid down in the law on the storage of medicinal products (979/2008) .
Where the medicinal product referred to in this Act is to be regarded as (166/2011) , it shall be subject to or provided for under the law referred to in that law. (17/06/2015)
Medicinal products may be prepared industrially only with the authorisation of the pharmaceutical safety and development centre in a pharmaceutical factory with acceptable production facilities and facilities. I promise to attach conditions. (16/10/2009)
The information required in the licence application and the application for authorisation shall be further specified by the Government Decree. The State Council Regulation also provides for a period within which the application for authorisation has to be resolved. (9.8.2002/700)
The Agency shall be responsible for taking information related to the authorisation of the European Medicines Agency to the database maintained by the Agency. (30.12.2013/1200)
The pharmaceutical plant must have a direct employment relationship with the responsibility of the Director, who is primarily responsible for ensuring that the medicinal products manufactured by the pharmaceutical company comply with the requirements laid down in this law or in accordance with it, and that they are of a quality And the fact that medicinal products are manufactured in accordance with the provisions of this Act concerning the manufacture and quality control of medicinal products and the provisions adopted pursuant thereto.
The responsible manager of a pharmaceutical plant must be a licensed pharmacist or other qualified higher education graduates. The responsible Director shall also be required to have worked in a pharmaceutical factory for a sufficient period of time in the manufacturing or quality assurance tasks of medicinal products. The responsible director shall not be at the same time as a responsible manager in another company which has been authorised industrially to produce medicinal products. In addition, the responsible director shall not be responsible for the wholesale supply of the other company or the pharmacist, the hospital pharmacist or the medical centre, the director of the military pharmacy, or the pharmacist or side-pharmacy operator. Where appropriate, the responsibilities of the responsible Director may be laid down in more detail by a decree of the Government.
In addition to the competence requirements referred to in Article 53 of the veterinary medicinal product directive or in Article 49 of the Medicinal Products Directive, unless the responsible Director meets the qualification requirements referred to in paragraph 2, the medicinal products shall be partly or wholly obtained by: The holder of the authorisation shall have at least one person who satisfies the eligibility criteria laid down in those Directives. The person meeting the eligibility criteria shall be responsible for the production of medicinal products in accordance with the marketing authorisation and good manufacturing practice. The Agency for the Safety and Development of the Medicinal Products may provide more detailed provisions on the duties of a person fulfilling the eligibility criteria.
A decree of the Council of State may provide for derogations from the qualification requirements of the unit responsible for the quality of medicinal products provided for in paragraphs 2 and 3 and of the responsible manager of the laboratory and the qualified person.
The manufacturing of the medicinal product may, if required by technical, economic or production factors, be carried out ( Contract preparation ) Or inspection ( Contract analysis ) In another pharmaceutical factory ( Contract manufacturer ) Or by a similar institution ( Contract analyst ).
The contractor and the contractor carrying out the release analyses of the medicinal product or medicinal product shall have the authorisation referred to in Article 8 for the industrial manufacture of medicinal products. The Contractor and the Contractor shall inform the Agency of the initiation of its activities at least 60 days before the commencement of the operation. The notification shall be accompanied by a copy of the contract between the pharmaceutical plant and the contract manufacturer or the contract analyst.
The Centre for the Safety and Development of Medicinal Products may lay down provisions on the procedures to be followed in the manufacture of contract and contract analysis.
The pharmaceutical company must comply with the good manufacturing practices of medicinal products which comply with the principles and guidelines approved in accordance with Article 47 of the Directive. Only active substances which have been manufactured and distributed in accordance with the European Union guidelines on the good production and distribution of medicinal products may be used in the preparation of medicinal products. The pharmaceutical plant shall ensure that manufacturers, importers and distributors in the Union from which they receive medicinal products for the manufacture of medicinal products for human use or registered medicinal products are registered The competent authority of the Member State in which they are established. The pharmaceutical company shall carry out evaluation visits at the manufacturing and distribution points of pharmaceutical products to ensure that manufacturers and distributors of pharmaceutical products comply with good manufacturing practice and good distribution practices. The pharmaceutical plant shall perform the verifications referred to above, or be authorised by an outside party. The authorisation shall be without prejudice to the responsibility of the pharmaceutical company under this Act. The manufacturer of authorised or registered medicinal products for human use shall identify appropriate good manufacturing practices for the excipients used in the preparation of medicinal products and ensure that they are complied with. The Agency for the Safety and Development of Medicinal Products may provide more detailed provisions on the good production and distribution of medicinal products and excipients. (30.12.2013/1200)
The pharmaceutical company shall keep a list of the sale of medicinal products. The list shall be kept for at least five years. The contents and storage of the list may be further specified by the Government Decree.
The medicinal product shall be notified to the Agency and to the holder of the marketing authorisation or registration immediately if it is informed that the market is or is suspected of having falsified medicinal products in the pharmaceutical company's manufacturing authorisation. , irrespective of whether or not they are lawfully or illegally distributed. (30.12.2013/1200)
The pharmacy and the associated branch shall only prepare medicinal products for the sale of the pharmacy, including the pharmacy side, and the cup of service.
However, the pharmacist may prepare individual medicines at another pharmacy and obtain individual raw materials imported under Article 17 (1) (3) for their own production. The pharmacist shall report this to the Pharmaceutical Safety and Development Centre. The Centre may lay down provisions on the procedure for the manufacture of medicinal products and for the preparation of the contract, as well as more detailed provisions on the notification procedure.
The machinery dose distribution and contract manufacture at the pharmacy and the hospital pharmacy requires the authorisation of the Agency for Security and Development in the pharmaceutical sector. The authorisation shall be granted if the action meets the requirements laid down in Article 15. The authorisation may be accompanied by the conditions required for the manufacture, transfer and use of the medicinal product and for other medicinal products.
The apothecary shall commission a machine-free distribution by contract on the basis of a contract in another container with a licensed dispensary.
The pharmacy, the pharmacy pharmacy, the hospital pharmacy and the pharmaceutical centre should submit a prior notification to the pharmaceutical safety and development centre for their own medicinal products.
The pharmacy or the medical centre may produce medicinal products to the extent necessary for the activities referred to in Article 62 (3) of the medical centre, the hospital or the health centre. The manufacture of medicinal products must be carried out in accordance with the principles and guidelines of the medicinal products approved by the European Community and the rules on the production of pharmaceutical products. The Convention on the approval of the Convention.
A medical pharmacy may commission the manufacture or repair of the medicinal product referred to in paragraph 1 at another hospital pharmacy where the manufacture requires special facilities. In addition, a medical pharmacy may commission the release of radioactive medicinal products in a pharmaceutical company in the European Economic Area as a contract. The authorisation of the contractual manufacturer shall cover the activities subject to the contract. In the case of medicinal products, the nurse responsible for completing the contract must submit a notification to the Centre for Security and Development in the pharmaceutical sector. The Centre may lay down rules on the procedures to be followed by the hospital pharmacy and the Centre for the manufacture of medicinal products and the hospital pharmacy must comply with the procedure for the manufacture of medicinal products and for more detailed provisions on the notification procedure. (30.12.2013/1200)
Pharmacists and pharmacies, pharmacy, hospital pharmacies and pharmaceutical centres are required to be adequately trained in the manufacture of medicinal products and the production facilities and equipment necessary for the manufacture of medicinal products. Are appropriate. In addition, the good manufacturing practice of medicinal products in accordance with Article 11 shall apply mutatis mutandis.
More detailed provisions on authorisation conditions may be laid down by a Council regulation. The Centre for the Safety and Development of the Pharmaceutical Centre may issue provisions on the application of Article 12a (1).
Medicinal products for clinical trials may be prepared with the permission of the Agency for Safety and Development in the pharmaceutical sector. The authorisation may be accompanied by the conditions required for the manufacture, transfer and use of the medicinal product and for other medicinal products.
In addition to the provisions laid down in paragraph 1, medicinal products used in clinical trials may be made by the authorisation holders referred to in Article 8 and the manufacturers of the medicinal products referred to in Articles 12 and 14, in accordance with the provisions of this Act and pursuant to that law. Provides and provides. These pharmaceutical manufacturers shall notify the pharmaceutical safety and development centre of the medicinal product used in a clinical trial before commencement of manufacture. (30.12.2013/1200)
In the case of medicinal products used in a clinical trial, the manufacture of medicinal products shall apply mutatis mutandis as regards the manufacture of medicinal products under this law or under this law.
The Agency may provide more detailed provisions on the manufacture of medicinal products used in clinical trials, the application for authorisation referred to in paragraph 1 and the notification referred to in paragraph 2.
In the case of medicinal products for clinical trials, the entity shall employ at least one of the laws, regulations and regulations of the Member States relating to the application of good clinical practice in the conduct of clinical trials on medicinal products for human use And the eligibility criteria specified in Article 13 (2) of Directive 2001 /20/EC of the European Parliament and of the Council on the approximation of the administrative provisions. The Centre for the Safety and Development of the Pharmaceutical Centre shall provide more detailed provisions for the tasks of this person. Where the pharmaceutical activity of the unit is extensive, the entity shall have a responsible manager whose duties and eligibility criteria are determined in accordance with Article 9. (16/10/2009)
The unit producing medicinal products for clinical trials may perform the contract manufacture of medicinal products for use in clinical trials under the conditions laid down in Article 10.
A unit manufacturing medicinal products for clinical trials shall comply with the good manufacturing practice of the medicinal products referred to in Article 11.
Advanced therapy medicinal products for advanced therapy and amending Directive 2001 /83/EC and Regulation (EC) No 726/2004 as referred to in Regulation (EC) No 1394/2007 Non-industrial manufacture of medicinal products requires the authorisation of the Agency for Security and Development in the pharmaceutical sector. The authorisation may be granted in order to prepare a medicinal product for individual treatment of individual patients at the hospital. The conditions for the manufacture, donation, traceability and use of the medicinal product and the conditions necessary for the safety of medicinal products may be included. The authorisation may be granted for a limited period or for an indefinite period.
The manufacture of advanced therapy medicinal products shall, where appropriate, comply with the provisions of this Act or the manufacture of medicinal products.
The Centre for the Safety and Development of Medicinal Products may provide more detailed provisions for the application of the authorisation referred to in paragraph 1 and of the content of the application, for the non-industrial manufacture of advanced therapy medicinal products. And the traceability and pharmacovigilance of preparations.
The Centre for the Safety and Development of the Pharmaceutical Centre shall adopt specific provisions for the prior notification referred to in Article 13 and for the provisions of Articles 12 and 14, the provisions of the European Communities and the checks on the production of pharmaceutical products On good manufacturing practice for medicinal products based on the approval of the Convention. The Agency for the Safety and Development of Medicinal Products may also provide more detailed provisions on the labelling of manufactured medicinal products.
Medicines should be imported:
(1) the person who is authorised to manufacture medicinal products in the pharmaceutical company;
(2) the authorisation of the wholesale trade in medicinal products pursuant to Article 32;
3) the pharmacist, pharmacy at the University of Helsinki, the pharmacy of Kuopio University and the Military pharmacy for the activities referred to in Article 12 (2);
(4) the hospital pharmacy in individual cases for the activities referred to in Article 62 (3) of the medical centre, hospital or health centre concerned;
(5) university, university and scientific research institute for its research activities; and
6. In addition to clinical trials, the person entitled to prepare medicinal products for clinical trials.
The hospital pharmacy, the university, the university and the scientific research institute must make a declaration to the Centre for the Safety and Development of the pharmaceutical industry. (16/10/2009)
Where a marketing authorisation or a registered medicinal product or a medicinal product intended for clinical trials is imported from a non-eea State, the importer shall be authorised to manufacture medicinal products in accordance with Article 8. The importer of the abovementioned medicinal products must ensure that medicinal products imported from countries outside the European Economic Area have been completed in Finland or in any other country in the European Economic Area Verification of quality assurance in accordance with the marketing authorisation requirements. The quality control of medicinal products imported from countries outside the European Economic Area is regulated by a Council Regulation. (30.12.2013/1200)
A trader other than the trader referred to in Article 1 (1) (1) to (3) may import medicinal products for its production activities. From this point of view, the trader shall make a declaration to the Centre for Security and Development in the pharmaceutical sector. (16/10/2009)
The pharmaceutical safety and development centre and the Customs may import the medicinal products necessary for them to carry out the supervisory tasks provided for in this Act. No authorisation shall be required from the Agency for the Safety and Development of Medicine or Customs. (30.12.2013/1200)
Medicinal products for use in the manufacture of authorised or registered medicinal products for human use shall be imported from outside the European Union or the European Economic Area only if the following conditions are met:
(1) the manufacture of medicinal products has undergone compliance with requirements which are at least equivalent to those laid down in the European Union's good manufacturing practice;
(2) the medicinal product is accompanied by written confirmation from the competent authority of the exporting third country that:
(a) the medicinal products exported from the country shall be subject to requirements equivalent to those laid down in at least the good manufacturing practice of the European Union established in accordance with the third paragraph of Article 47 of the Medicinal Products Directive;
(b) that the manufacturing plant is subject to regular strict and transparent controls, repeated and without prior notification, or other equivalent effective production methods of control, in order to ensure at least: A similar level of public health protection as in the European Union;
(c) the exporting third country shall provide information on the non-compliance with the observed requirements without delay to the Union.
The requirements referred to in this Article shall not apply where the exporting country is on the list maintained by the Commission referred to in Article 111b of the Medicinal Products Directive.
If a Member State of the European Union or a State belonging to the European Economic Area has inspected the active substance for export and has found that it complies with the good manufacturing practice established in accordance with Article 47 of the Directive , the Centre for the Development of Medicinal Products for Safety and Development (hereinafter referred to as the Agency for the Safety and Development of Medicinal Products) may, by way of derogation from the provisions of this Article, be exempted from the provisions of this Article. Requirements of a certificate not exceeding good manufacturing practice For the period of validity. The Agency shall inform the European Commission of the granting of the exemption.
The Agency may, where appropriate, provide more detailed provisions for the importation of medicinal products under paragraph 1.
The list of imported medicinal products and the notification referred to in Article 17 (2) of that Regulation are laid down by a decree of the Government.
For the purpose of personal medication, a private person may bring medicinal products obtained from a supplier eligible for retail distribution. Imports of medicinal products are not permitted. The acquisition of a prescription should be based on a prescription issued by a person entitled to prescribe a medicinal product. In addition, a person entering the country from abroad may, at the same time, bring in the same quantity of medicines needed for the treatment of a person who is imported into the country at the same time.
A person entitled to the profession of a doctor or a veterinarian who is not normally resident in Finland may, when he comes to the country, bring with him and use a medicinal product which has a marketing authorisation in the country in which he is mainly engaged in his profession, If the entry and the need for medicinal products are based on a person or group of persons or groups of persons or groups of persons or groups of animals or groups of persons involved in an international sporting event on a temporary basis, or A medical need. However, the right to import is not subject to criminal law (39/1889) in Chapter 44, Section 16 Of doping substances. Medicinal products imported into the country may only be used for the treatment of those who are responsible for the medical treatment of the doctor who has responded to the country or the animals under the responsibility of the veterinarian.
If a qualified doctor, a dentist or a veterinarian who is resident in Finland has taken medicines to prepare for the temporary stay abroad of persons or animals who are normally resident in Finland or have been temporarily resident abroad, he shall: Medicinal products not used in Finland.
The Regulation of the Council of State may provide for more detailed conditions for imports referred to in paragraphs 1 to 3, as well as the restrictions on the supply of the medicinal product, the way in which the medicinal product is procured, the competition or any other event referred to in paragraph 2. The quality and the maximum quantity of the product imported. A decree of the Council of State may also prohibit or restrict the right to import medicinal products containing substances classified as narcotic substances under paragraph 2. Imports under paragraph 2 may also be subject to prior notification to the authority or to the organiser of the event on grounds of temporary residence, on the basis of the criteria laid down by the Council Regulation. The Regulation of the Council of State may also restrict the import of substances used in veterinary medicinal products, where they may endanger the safety or quality of food products, or where they may lead to significant other Animals, human beings or the environment, or may jeopardise the resistance of Finnish animal diseases.
The provisions of this Chapter shall apply to medicinal products and medicinal gases which have been industrially manufactured or imported.
The sale of a medicinal product to the general public or any other release for consumption requires that the Centre for Safety and Development of Medicine has authorised or registered the product in accordance with this law, or that it has a European The marketing authorisation granted.
The Agency shall grant a marketing authorisation for medicinal products other than those of the European Parliament and of the European Parliament concerning the authorisation and supervision of medicinal products for non-human and veterinary use For medicinal products in accordance with the Annex to Council Regulation (EC) No 726/2004, if:
(1) the product is deemed appropriate as a medicinal product;
(2) the product cannot be considered hazardous to the patient's health, user or public health and, in view of its intended use, the product cannot be considered as hazardous either to the consumer, to the environment or to the target animal: The beneficial effects of the preparation in relation to the risks related to its quality, safety and efficacy ( Risk-benefit balance );
(3) the product complies with the requirements for the production and quality of the pharmacopoeia or other equivalent;
(4) the effects of the medicinal product and the medicinal product have been established through appropriate preclinical and clinical studies; and
(5) the composition and other information of the preparation has been duly reported.
(16/10/2009)The Agency may attach conditions to the marketing authorisation of the medicinal product if necessary to ensure the correct and safe use of the medicinal product. In addition, the Centre for the marketing authorisation subject to the Medicinal Products Directive may attach conditions to the conclusion of safety and efficacy studies after the authorisation has been granted, as well as the recording or reporting of suspected adverse reactions. Where appropriate, the marketing authorisation shall set deadlines for the fulfilment of the conditions. (3.5.2013/330)
The marketing authorisation may, for reasons related to the safety or efficacy of the medicinal product, be conditional on the marketing authorisation holder's obligation to take the measures provided for in the marketing authorisation. The Agency shall publish the criteria for which the marketing authorisation has been granted as conditional and on the measures to be taken. The mah must report annually to the Pharmacovigilance Centre on the implementation of the terms of the marketing authorisation. (16/10/2009)
The marketing authorisation is not required for a radioactive medicinal product prepared at the time of use using radionuclide generators, combinations of preparations or radioactive stock solutions which have a marketing authorisation.
By way of derogation from Article 21 (1) (4) and without prejudice to the legislation on the protection of industrial and commercial rights, the applicant need not provide the results of the pre-clinical and clinical trials; and In the case of a veterinary medicinal product, the results of safety and residue studies, if the applicant can demonstrate that an authorisation is sought for a generic product which is or has been authorised in accordance with Article 21 or the European Economic Area; A marketing authorisation issued by the State or the European Community, at least For eight years. If, in the case of the biological medicinal product, in particular raw materials or manufacturing processes are different from the reference product, the applicant shall attach to the application the results of the preclinical preclinical prescriptions of the Pharmacovigilance Centre. And clinical trials. If necessary, the Centre shall lay down more precise rules on the way in which the consistency of raw materials and production methods is to be demonstrated. (16/10/2009)
However, the results of the appropriate pre-clinical and clinical trials, as well as the results of appropriate safety and residue studies, should be provided if the product does not comply fully with the definition of a generic medicinal product in accordance with Article 5c. Or where bioequivalence has not been demonstrated in bioavailability studies or the therapeutic indication or route of administration of the product is different from the reference product.
The marketing authorisation of a parallel preparation shall take effect no earlier than 10 years after the initial authorisation of the reference product is granted. If, over the next eight years, the marketing authorisation holder of the reference product may authorise one or more new therapeutic indications which have been assessed in the scientific assessment to obtain authorisation To produce significant clinical benefits compared to existing therapies, shall not enter into force at the earliest 11 years after the initial authorisation of the reference product.
Where a veterinary medicinal product containing a new active substance is intended for one or more production animals, the 10-year period referred to in paragraph 3 shall be extended for one year each time the authorisation is extended to the new species of production. However, the extension may not exceed three years. The extension shall be subject to the granting of the extension of the marketing authorisation within five years of the marketing authorisation of the reference product. In addition, the holder of the marketing authorisation has made a Community procedure for laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (hereinafter referred to as Residue regulation , an application for the establishment of maximum residue limits for the species subject to authorisation. An extension of the 10-year period referred to in this paragraph may not be made to a veterinary medicinal product whose marketing authorisation was granted on 30 April 2004 or before.
However, the marketing authorisation for a generic medicinal product for fish, bees or other species designated in accordance with the procedure referred to in Article 89 (2) of the veterinary medicinal products Directive shall enter into force at least 13 years after the reference product Granting a marketing authorisation.
When applying for a marketing authorisation for a medicinal product for which the quality and quantity of the active substances and the pharmaceutical form are the same as the product previously authorised, the marketing authorisation holder has given its consent to the marketing authorisation application for this product. In the case of pharmaceutical, pre-clinical and clinical results, and for the veterinary medicinal product, including the use of the results of safety and residue studies, the application for marketing authorisation does not need to be accompanied by the results of such studies.
By way of derogation from Article 21 (1) (4) and without prejudice to the legislation on the protection of industrial and commercial rights, the applicant is not required to supply pre-clinical and clinical The results of the studies and the results of the safety and residue studies, if he demonstrates that the active substances contained in the product have been consistently used in a medicinal product within the European Economic Area. In the State for a period of at least 10 years and their effectiveness is recognised and Their safety level has been approved. The effectiveness and safety level shall then be demonstrated by appropriate scientific literature, as specified by the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
If the medicinal product contains several active substances in the composition of authorised medicinal products that have not previously been used in combination for therapeutic purposes, the combination shall be provided with pre-clinical and clinical The results of the studies and, where appropriate, safety and residue studies, where appropriate. On the other hand, the individual active substances of the combination need not be provided with the results of the studies mentioned or the publication references referred to in paragraph 1. The time-limits provided for in Article 21a (1) and (3) to (5) shall apply to generic generic combinations of new combinations of medicinal products.
Where a new therapeutic indication is accepted for a commonly accepted medicinal product on the basis of significant pre-clinical or clinical studies, a new use may be sought for a generic medicinal product based on these studies, not earlier than one year. To modify the marketing authorisation of the reference product. The restriction applies only to the first new use.
If new MRLs have been carried out for the veterinary medicinal product for the production animal in accordance with the residue regulation and new clinical trials to obtain a marketing authorisation for another animal species, and these studies shall be: Taken into account in the granting of a marketing authorisation pursuant to paragraph 1, the second applicant for a marketing authorisation may refer to these studies no earlier than three years after the first authorisation was granted.
If a medicinal product authorised in Finland is authorised in Finland, non-marketing authorisation holder or a representative authorised to import this medicinal product should have a parallel import licence for the medicinal product. The Agency for Safety and Development in the pharmaceutical sector shall grant a parallel import licence where there is no therapeutic difference between the parallel importer and the product authorised in the past. A parallel import licence may only be granted for a medicinal product belonging to the European Economic Area.
By way of derogation from Article 21 (1) and (2), the Agency may, by way of derogation from the provisions of Article 21 (1) and (2), authorise the use of the medicinal product if there are specific criteria for the use of harmful pathogens, toxins or chemical substances. Or any suspected outbreak of harmful nuclear radiation and no other appropriate treatment or medicinal product is available.
For specific therapeutic or public health reasons, the Agency may, without prejudice to Article 21, grant temporary authorisation ( Special authorisation ) To release the medicine for consumption. The special authorisation procedure and the conditions for granting a special authorisation may be laid down in more detail by a decree of the Government.
Notwithstanding the provisions of this Act, the Food Safety Agency may, in the event of a serious outbreak of animal disease, grant an import and use authorisation for an immunological veterinary medicinal product which does not have a marketing authorisation if the appropriate preparation is not: Otherwise available, or if the disease situation is otherwise required. The authorisation shall be notified without delay to the Agency for Safety and Development in the pharmaceutical sector.
Article 21h has been repealed by L 16.5.2014/388 .
The traditional herbal medicinal product intended for human consumption must be registered. The pharmaceutical safety and development centre shall register a traditional herbal medicinal product if:
(1) the product is suitable for use on the basis of its composition and indication, without diagnosis, prescription or treatment control by a doctor;
2) the product is intended for oral, external or inhalation;
(3) adequate knowledge of the traditional use and safety of the product, as well as the pharmacological effects and efficacy;
(4) the preparation or preparation containing the same active substances, the same or similar indication, the same strength and dosage, and the same or similar route of administration other than the product to which the application is submitted, has been preceded by the application A working day as a medicinal product for a continuous period of at least 30 years, of which 15 years in the country of the European Economic Area; and
(5) the product does not fulfil the conditions for a marketing authorisation in accordance with Articles 21 or 21c and not in accordance with Article 22a.
Where registration is sought for a product which has been used for less than 15 years in the countries of the European Economic Area and which otherwise complies with the conditions of registration provided for in paragraph 1, the Agency shall: Refer the matter to the Herbal Medicinal Products Committee of the European Medicines Agency. Derogations from the 15-year period of use may be waived if the Committee draws up a Community herbal monograph. The face monograph shall be taken into account when the final decision is taken, unless specifically related to the safety of the medicinal product.
The Agency may attach conditions to the registration in order to ensure the correct and safe use of the traditional herbal medicinal product and the conditions of the place of sale.
A homeopathic medicinal product which is to be released for consumption, not subject to the marketing authorisation procedure laid down in Article 21, shall be registered. Such a preparation shall be registered by the pharmaceutical safety and development centre if:
(1) the preparation is for oral or external use; the product used for the animal may also have another route of administration described in the pharmacopoeia;
(2) there is no specific medicinal product indication for the labelling of the product or any information related thereto;
(3) the product does not contain more than one-tenth of a fraction of the stock solution or more than one per hundredth of the dose of the pharmaceutical substance used in the lowest conventional medicine used; and
(4) the product does not fulfil the conditions of the marketing authorisation under Article 21.
The Agency may attach conditions to the registration in order to ensure the safe and correct use of the product and the conditions of the place of sale.
The homeopathic medicinal product manufactured in the pharmacy shall not be registered, but it shall be subject to prior notification to the Agency for Safety and Development.
The Agency shall take into account the competent authority of the other Member State of the European Economic Area on the issue of marketing authorisation, registration and modification of the medicinal product. Applications pending before the Pharmacovigilance Authority and decisions taken by the competent authority and following the granting of a marketing authorisation by the institution of the European Union, the modification of the medicinal product and the withdrawal of the authorisation granted, or Decisions on the prohibition of release for consumption Is laid down in European Community acts.
Unless authorised or proposed by another Member State of the European Economic Area, an assessment report, summary of product characteristics, package leaflet or On the basis of a serious risk to public health or, in the case of a veterinary medicinal product, a risk to humans, animals or the environment, it shall provide a detailed and reasoned explanation of its position for that The Member State and the applicant for the marketing authorisation or registration. The Agency should take into account the guidance of the European Commission in assessing the risk of serious public health or risk to humans, animals or the environment.
If, in addition to Finland, an application pending before the competent pharmaceutical supervisory authority of one or more of the Member States of the European Economic Area has been submitted to an institution of the European Union, the , the Centre may, at the request of the applicant, grant a marketing authorisation. The European Centre for Security and Development in the pharmaceutical sector, acting on its own initiative, shall take measures to amend the marketing authorisation it has granted to the European Union institution.
The marketing authorisation or other authorisation for the consumption of the medicinal product shall not be granted to a veterinary medicinal product intended for use in farmed animals and containing certain substances having a hormonal or thyrostatic action, and Establishing a prohibition of the use of beta-agonists in stockfarming and repealing Directives 81 /602/EEC, 88 /146/EEC and 88 /299/EEC as hormonally, thyreostatically or beta-agonist Unless the medicinal product is intended to: Directive adopted.
If a marketing authorisation or a registered medicinal product is to be changed or where technical and scientific progress is required to change the product, the marketing authorisation or registration holder shall make an application for safety and safety in the pharmaceutical sector. To the Centre. The Centre shall approve the amendment if it complies with the requirements laid down in the amended authorisation or registration. The Agency shall submit an application to all Member States which have granted a marketing authorisation under the Medicinal Products Directive. All subsequent strengths, pharmaceutical forms, routes of administration and type of packaging, as well as any changes and extensions, become part of the original marketing authorisation or registration, unless they have been submitted separately for marketing authorisation or registration. However, amendments which do not materially affect the assessment of the conditions of the marketing authorisation or registration of a product shall only be notified to the Agency for Safety and Development in the pharmaceutical sector. (13/03/98)
If the marketing authorisation or registration of the medicinal product is a fixed term, the amended authorisation or registration shall be valid in accordance with the original deadline.
The Centre for the Safety and Development of Medicinal Products shall provide more detailed provisions on the changes referred to in paragraphs 1 and 2, the request for amendment, the notification of the amendment and the procedure applicable to them.
If a condition attached to the marketing authorisation that the medicinal product intended for human use is to be supplied only on the basis of a prescription ( Prescription condition ), removed on the basis of extensive pre-clinical or clinical trials carried out by the marketing authorisation holder, the marketing authorisation holder of another medicinal product containing the same active substance may apply for the removal of a prescription based on these studies. No earlier than one year after amending the condition of the marketing authorisation of the reference product.
After the granting of a marketing authorisation covered by the Directive, the Agency may decide that a safety study or an efficacy study shall be carried out by the marketing authorisation holder.
Post-authorisation safety study may be prescribed if it is justified on the basis of information obtained after the authorisation of the marketing authorisation. Where the same safety information relates to more than one medicinal product, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency shall consult the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency for conducting a joint safety investigation.
Post-authorisation efficacy studies may be established if data from clinical trials or otherwise received suggest that there may be a significant need to check previous efficacy assessments.
The Agency shall notify the marketing authorisation holder in writing of its intention to impose an obligation on post-authorisation efficacy or safety studies. The investigation order shall be justified, specifying the objectives and the timetable for carrying out the investigation. The marketing authorisation holder shall be entitled to submit written comments on the obligation to carry out a study within a reasonable period set by the Agency for the safety and development of the medicinal product if the marketing authorisation holder requests this within 30 days. The receipt of a written notification.
If the pharmaceutical safety and development centre decides to impose the obligation, the obligation becomes part of the marketing authorisation as a condition. Accordingly, the marketing authorisation holder shall update its risk management system in this respect.
The marketing authorisation referred to in Articles 21 and 21a to 21d and the registration referred to in Articles 22 and 22a shall be valid for a period of five years after the first authorisation or registration was granted. Authorisation and registration may be renewed. The revised marketing authorisation and registration shall be valid until further notice, unless the pharmaceutical safety and development centre decides, on grounds of pharmacovigilance, that the renewal or registration is valid for a period of five years. After the second five-year period, the authorisation and registration will remain in place for the time being.
An application for the renewal of a marketing authorisation or registration shall be submitted to the Agency in writing at the latest nine months before the expiry of the authorisation or registration. However, in the case of a medicinal product subject to the veterinary medicinal product directive, the application must be made at least six months before the expiry of the authorisation or registration. (3.5.2013/330)
The marketing authorisation referred to in Articles 21 and 21a to 21d and the provisional authorisation referred to in Article 21e and the registration may be granted to a natural or legal person established in a State belonging to the European Economic Area.
A special permit may be issued for pharmacies, branches, military pharmacies, pharmacy, pharmaceutical wholesalers, pharmaceutical companies, health and welfare institutions, the Food Safety Agency and the Finnish Red Cross. (16/10/2009)
Applications for authorisation and registration as well as their modification or renewal shall be submitted by a written and signed application to the Medical and Development Centre. The notification referred to in Article 23a (1) shall also be submitted in writing to the Medical and Development Centre in the pharmaceutical sector and must be signed. The Agency shall provide more detailed provisions for the submission of the applications and notifications referred to in this Chapter, as well as the reports accompanying them and the labelling and package leaflet of the package leaflet. The medicine pack. (16/10/2009)
The period of application of the application for authorisation, registration, amendment or renewal shall be laid down by a decree of the Government.
The Agency shall draw up an assessment report on the medicinal product for which a marketing authorisation has been applied. The assessment report shall be updated whenever significant new information is available on the quality, safety or efficacy of the medicinal product. The assessment report and its explanatory statement, which have been deleted from business and professional secrecy, shall be publicly available. The assessment report shall include a summary of the conditions for the use of the medicinal product. The Pharmaceutical Safety and Development Centre shall publish a marketing authorisation decision for the medicinal product, the conditions attached to the marketing authorisation and, where appropriate, the time limits for the fulfilment of the conditions, the summary of product characteristics and the package leaflet.
In the case of a medicinal product covered by the veterinary medicinal product directive, the Agency shall draw up, keep publicly available and update the assessment report, as provided for in paragraph 1, without I have a summary. A marketing authorisation decision, a summary of product characteristics and a package leaflet shall be published in the veterinary medicinal product directive.
The Agency for Safety and Development in the pharmaceutical sector may, for a justified reason, grant exemptions from the provisions on information to be provided on the labelling and package leaflets of medicinal products and on the obligation to draw up labelling and package leaflet for medicinal products. In Finnish and Swedish if the medicinal product is not intended for direct delivery to the patient or where there are serious problems with availability and the granting of derogations does not compromise human or animal health.
The marketing authorisation holder and the holder of the registration referred to in Article 22 shall ensure that the authorised medicinal product and the registered traditional herbal medicinal product are continuously available to pharmaceutical wholesalers and pharmacies. The need for patients and other users.
The marketing authorisation, co-import authorisation and registration holder shall inform the medical and development centre of the medicinal product:
(1) to trade, eight working days before the start of the sale;
(2) temporary or permanent suspension of trade, as well as for medicinal products for human use, at least two months before the suspension of the sale, subject to special circumstances.
In addition, the marketing authorisation, the marketing authorisation holder and the marketing authorisation holder shall immediately inform the Medical and Development Centre of the marketing authorisation or suspension of the marketing authorisation for the medicinal product, Measures relating to the withdrawal or non-renewal of a marketing authorisation, as well as the reasons for such measures. If such measures are based on the harmfulness of the medicinal product, the efficacy, the negative risk-benefit balance or the safety of the medicinal products, the notification shall also be made to the European Medicines Agency. Where measures have been taken outside the EU and EEA outside the EEA, for reasons related to the efficacy, the risk-benefit balance or the safety of medicinal products, the safety and safety of the medicinal product shall be notified without delay; - The Centre and the European Medicines Agency.
If a medicinal product other than that authorised by the marketing authorisation holder or its representative is to be imported into Finland by the European Union institution, the importer shall notify the import to the medical and development centre and the marketing authorisation To the holder. The notification shall be made at least one month before the intended start of the import.
Article 2 (2) does not apply to veterinary medicinal products.
The authorisations referred to in Articles 21 and 21a to 21g, the registrations referred to in Articles 22 and 22a and the marketing authorisation and registration referred to in Article 23a shall be paid. Payments may be made in advance. In addition, the measures relating to authorisation and registration may be levied in whole or in part as an annual fee. The fees are laid down in more detail by a decree of the Ministry of Social Affairs and Health, taking into account what is or is provided for by the State payment law or by virtue of its charges. The Agency for Safety and Development in the pharmaceutical sector may give more detailed provisions on the payment of fees.
The marketing authorisation and registration shall lapse if the holder:
(1) has not made a conditional sale permit within the time limit referred to in Article 21 (3);
(2) have not completed the annual fee referred to in Article 28 within the time limit; or
3) has not imported the product within three years of the granting of a marketing authorisation or registration or marketing has been continuously interrupted for three years.
In addition, the Agency may revoke the marketing authorisation and registration if it has been possible to demonstrate that the conditions for the authorisation or registration are no longer available. The marketing authorisation and registration may be withdrawn for the duration of the necessary investigations if there is reason to suspect that the conditions for the granting of a marketing authorisation or registration are no longer valid. (16/10/2009)
On application by the holder of a marketing authorisation or registration of a marketing authorisation or registration, the Agency may decide, on application by the holder of a marketing authorisation or a registration, that the marketing authorisation or registration shall not lapse in accordance with paragraph 1 (3) On that basis. The marketing authorisation and registration holder shall submit an application to the pharmaceutical safety and development centre for the renewal of a marketing authorisation or registration at least three months before the three-year deadline. The Agency shall issue a decision within one month of receipt of the application. (16/10/2009)
Paragraph 4 has been repealed by L 3.5.2013/330 .
The necessary costs arising from the examinations referred to in paragraph 2 may be imposed, in whole or in part, for the holder of the marketing authorisation or registration.
The provisions of this Chapter shall apply to the marketing authorisations covered by the Directive and to registrations of Article 22.
This Chapter shall not apply to medicinal products covered by the veterinary medicinal product directive, with the exception of the person responsible for pharmacovigilance, the register of adverse reactions and the declaration of product errors provided for in Articles 30c, 30e and 30 o.
For the purposes of this chapter:
(1) With adverse effects Harmful and non-intended effect of the medicinal product;
(2) Pharmacovigilance system The system used by the marketing authorisation holder, the holder of the registration or the Centre for Security and Development in the field of pharmacovigilance for the fulfilment of the tasks and responsibilities of pharmacovigilance, to monitor the presence of authorised or The safety of registered medicinal products and the detection of any changes in their risk-benefit balance;
(3) Pharmacovigilance system master file A detailed description of the pharmacovigilance system used by the marketing authorisation holder to use one or more of the medicinal products or preparation that has been authorised or registered, and
(4) Risk management system A set of pharmacovigilance activities designed for the identification, characterisation, prevention or minimisation of risks associated with medicinal products, including those activities and the effectiveness of those measures; Evaluation.
The Agency shall have a pharmacovigilance system for pharmacovigilance tasks and for the participation of the European Union in pharmacovigilance activities. The Pharmacovigilance System shall be used to collect information on the adverse effects on humans arising from the use of the medicinal product, adverse reactions in humans related to occupational exposure and other risks of a medicinal product: Related to patients' health or public health.
The Agency shall review and evaluate its pharmacovigilance system regularly and report the results to the European Commission every two years.
The marketing authorisation, the parallel import licence and the registration holder shall have a system of pharmacovigilance, which shall provide for a scientific evaluation of all information of the medicinal product, considering options for minimising and preventing risks Where appropriate, appropriate measures.
The marketing authorisation, parallel import licence and registration shall be permanently and continuously available to the person responsible for pharmacovigilance, who shall be entrusted with the tasks related to the safety and promotion of medicinal products. The person responsible for the pharmacovigilance activities shall have the training and experience required for their duties. The place of residence of the person responsible for pharmacovigilance shall be within the territory of the European Union. The marketing authorisation, co-import authorisation and registration holder shall indicate the name and contact details of the person responsible for pharmacovigilance to the Agency for Safety and Development and the European Medicines Agency. The marketing authorisation holder of the medicinal product covered by the veterinary medicinal product directive and the holder of a parallel import marketing authorisation shall also have at its disposal a person responsible for pharmacovigilance, whose place of residence shall be in the European Union In a member state.
The Agency for the Safety and Development of Medicinal Products may provide more detailed provisions on the tasks of the pharmacovigilance person.
The Agency for the Safety and Development of Medicinal Products may, where appropriate, request a marketing authorisation, a parallel import licence and a registration holder to designate a pharmacovigilance liaison officer at national level, reporting on pharmacovigilance The person responsible.
In addition to the provisions of Article 30c concerning the pharmacovigilance system, the pharmacovigilance system maintained by the marketing authorisation holder and the holder of the registration shall include:
(1) maintain the pharmacovigilance system master file;
(2) maintain a risk management system for each medicinal product including the conditions attached to the marketing authorisation;
(3) monitor the results of measures designed to reduce risks and which are included in the risk management plan or are set out in the terms of the marketing authorisation;
(4) update the risk management system and monitor pharmacovigilance data to assess whether new risks have arisen, whether the risks have changed or whether the risk-benefit balance of the medicinal products has changed.
The marketing authorisation, co-import authorisation and registration holder shall verify and evaluate the pharmacovigilance system regularly. The pharmacovigilance system master file shall include information on the main findings during the examination and shall ensure that an appropriate corrective action plan is taken and implemented on the basis of the findings. The data may be deleted after corrections have been made. A copy of the stock file shall be submitted to the Pharmaceuresponsible Safety and Development Centre on request within seven days of receipt of the request.
The Agency may provide more detailed provisions on the content of the risk management system.
The marketing authorisation holder of the medicinal product, the parallel import authorisation and the registration holder of a traditional herbal medicinal product must maintain a register of adverse effects to ensure medical and patient safety. The register shall contain all information necessary to ensure the safety of the medicinal product and the suspected adverse reaction of the medicinal product, the diseases or bends of the medicinal product used by the controller to ensure the safety of the medicinal product, All medicinal products, therapeutic indications and adverse drug reactions, as well as information necessary for the identification of the user, such as name and personal identification number. However, if the adverse reaction occurs in the animal, instead of information from the patient, the data should be stored in order to identify the animal's owner and the animal species. The registry administrator shall inform the Agency of the information entered in the register. In addition, the marketing authorisation holder shall inform the Agency of any prohibition or restriction imposed by the competent authorities of the competent authorities of the countries in which the product has been placed on the market and of any other new Information which may affect the assessment of the benefits and risks of that preparation.
The Centre for the Safety and Development of Medicine shall record the information referred to in the first subparagraph in a national register of adverse effects in order to ensure the safety of medicinal products and patients. In addition, the Agency may at any time request information on the risk-benefit balance of the medicinal product.
The marketing authorisation of the medicinal product, the parallel import authorisation and the registration holder of a traditional herbal medicinal product, as well as the information contained in the Pharmacovigilance and Safety and Development Centre, may only be used in the The monitoring and reporting of adverse reactions, scientific research and the assessment of the safety and risk-benefit balance of medicinal products. However, information shall not be disclosed or used in decision-making concerning registration. The Agency for Safety and Development in the pharmaceutical sector should disclose information on the vaccine received to the health and welfare institution. Information may be transferred from the adverse impact register maintained by the Agency for Safety and Development in the pharmaceutical sector through a technical service. Before opening a technical service, the requesting information shall provide a statement that the data protection is adequately protected.
The Centre for the Safety and Development of Medicinal Products may, without prejudice to confidentiality rules, disclose personal data contained in its register of adverse reactions in the field of healthcare, disease prevention or treatment or related to For scientific research, where the protection of the privacy of the data subject is safeguarded in the (523/1999) In the manner prescribed. Before handing over information to the Data Protection Supervisor, an opportunity shall be given to be heard. The decision to disclose information must be accompanied by the provisions necessary to safeguard the privacy of the data subject.
The marketing authorisation holder of the medicinal product, parallel import authorisation and registration of a traditional herbal medicinal product shall keep the data for 50 years after the end of the marketing authorisation or registration. The data shall then be destroyed within one year, unless the Centre for Safety and Development in the pharmaceutical sector decides, for a specific reason, that data retention should be maintained for a maximum period of five years. The Centre for the Safety and Development of the Medicinal Products Agency shall keep records of the adverse effects on the register for 50 years.
The national register of side effects is also regulated by the law on national health registers (18/06/1989) . The Centre for the Safety and Development of Medicinal Products provides more detailed provisions for the maintenance of the affected register and the notification of information to the Agency for Safety and Development in the pharmaceutical sector. The Agency may, where appropriate, adopt provisions on the notification of adverse reactions to medicinal products authorised to prescribe and supply medicinal products.
In addition to the provisions of Article 30e (1), the marketing authorisation, parallel import licence and registration holder shall record all of its information, irrespective of any suspected adverse reaction in the territory of the European Union or in third countries. Whether they are based on declarations by patients or healthcare professionals or whether they have occurred in post-authorisation or post-authorisation studies. The marketing authorisation, parallel import licence and registration holder shall ensure that notifications are made available in a single contact point within the European Union.
The marketing authorisation, the parallel import licence and registration holder shall electronically notify all serious adverse reactions in the territory of the European Union to the competent authority of the Member State in whose territory the harmful The event happened. Where a suspected serious adverse reaction occurs outside the European Union, the marketing authorisation, parallel import licence and registration holder shall inform the European Medicines Agency and, upon request, the competent authorities of Member States Authorities in which the medicinal product has been authorised. The notification shall be made within 15 days of the date on which the marketing authorisation, parallel import authorisation and registration holder was informed.
The Agency shall inform the emea of serious adverse reactions to the EudraVigilance database of the European Medicines Agency without delay and at the latest 15 days after notification of adverse reactions. Of receipt.
Pursuant to Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency The marketing authorisation holders of medicinal products containing the active substances referred to in the monitoring list need not notify the EudraVigilance database of suspected adverse reactions listed in the list In medical literature. However, marketing authorisation holders shall monitor all other medical literature and report any suspected adverse reactions.
The marketing authorisation, parallel import licence and registration holder shall establish a procedure for obtaining accurate and verifiable information for the scientific assessment of suspected adverse reactions. The marketing authorisation, parallel import licence and registration holder shall also collect monitoring data on notifications and submit updates to the Medical and Development Centre. The marketing authorisation, the parallel import licence and the registration holder shall cooperate with the European Medicines Agency and the Member States in order to identify overlaps of suspected adverse reactions.
The Agency shall inform the European Medicines Agency of any suspected serious adverse reactions from which it receives information from a healthcare professional or a patient. The Centre shall transmit the notifications electronically to the EudraVigilance database within 15 days of receipt of the notifications. In addition, the Centre for Security and Development in the pharmaceutical sector shall inform the holder of any information it has entered in the register, including personal data, the marketing authorisation or registration holder.
The Centre for the Safety and Development of Medicine shall inform the Agency for Social and Health Authorisation and Health and Welfare at the Centre's information on the errors resulting from the use of the medicinal product Suspected adverse reactions. The Agency for Social and Health Authorisation and Health and the Health and Welfare Institution shall immediately inform the Agency of suspected adverse reactions which have been brought to their attention.
The Agency shall cooperate with the European Medicines Agency and the marketing authorisation holders in order to identify overlaps of suspected adverse reactions.
The Agency shall maintain a national medicines website on medicinal products for medicinal products for human and veterinary use and the European Medicines Agency (emea) For the European Medicines Agency established in accordance with Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council.
In addition to the information provided for in Article 25a, the Agency shall, in addition to the information provided for in Article 25a, have access to the following information:
(1) a summary of the risk management plans for medicinal products which have been authorised or registered in accordance with this law;
(2) the list of medicinal products referred to in Article 23 of that Regulation;
(3) information on the different ways in which a healthcare professional or a patient can report suspected adverse reactions to medicinal products to the Agency for Safety and Development.
If the marketing authorisation holder intends to issue a general communication on pharmacovigilance concerns related to the use of the medicinal product, the holder shall, without delay, and at the latest at the time of the communication, inform the To the Agency, the European Medicines Agency and the European Commission.
The marketing authorisation, parallel import licence and registration holder shall ensure that information to the public is presented impartially and that they are not misleading.
The Agency shall inform the European Commission, the European Medicines Agency and the competent authorities of the Member States of the European Economic Area in relation to the general Of a communication at least 24 hours before its adoption, unless it is a matter of urgency necessary for the protection of public health.
Where a general communication contains personal data or information of a commercially confidential nature, the Centre for Security and Development in the pharmaceutical sector may (18/09/1999) , and without prejudice to the provisions on the processing of personal data of the Personal Data Act, to the extent that such information is necessary in view of the protection of public health.
The marketing authorisation, the parallel import licence and registration holder shall submit electronically to the Pharmacovigilance Safety and Development Agency the periodic safety update reports containing:
(1) the summaries of information relevant to the benefits and risks of the medicinal product and the results of any studies that have estimated the potential impact of the data on the marketing authorisation;
(2) scientific assessment of the risk-benefit balance of the medicinal product;
(3) all information on the volume of sales of the medicinal product and information on the number of prescriptions held by the marketing authorisation holder and an estimate of the population exposed to the medicinal product.
By way of derogation from paragraph 1, the marketing authorisation holder referred to in Article 21a, Part-21c, 22 and 22a shall only submit periodic safety update reports if:
(1) The Agency for Safety and Development in the pharmaceutical sector has made a marketing authorisation conditional on Article 21 (2) or Article 23c; or
(2) The Agency for Safety and Development in the Pharmaceutical Sector shall require this pharmacovigilance-related information, on the basis of or on the basis of a post-authorisation period for the active substance No safety update reports have been submitted.
The frequency of periodic safety update reports shall be indicated in the decision on the marketing authorisation and registration. The dates of the PSURs shall be calculated from the date of decision.
The Agency shall initiate the urgent procedure of the Union within the meaning of Article 107i of the Medicinal Products Directive, if it is deemed necessary as a result of the evaluation of the pharmacovigilance data, Other Member States of the European Union, the European Medicines Agency and the European Commission. An urgent Union procedure shall be initiated if the Centre for Security and Development in the pharmaceutical sector:
(1) consider suspending or revoking a marketing authorisation or registration;
(2) consider prohibiting the supply of a medicinal product;
(3) consider refusing to renew a marketing authorisation or registration;
(4) has been informed by the marketing authorisation or registration holder that this is for safety reasons:
(a) suspension of the medicinal product on the market;
(b) or intends to take action to withdraw the marketing authorisation or registration;
(c) has not applied for renewal of the marketing authorisation; or
(5) Whereas it is necessary to take urgent action to increase the new contraindication, reduce the recommended dose or restrict the use of the medicinal product.
(13/03/98)However, where the measures referred to in paragraph 1 (5) are not necessary as a matter of urgency, the Centre for the Safety and Development of the Medicinal Products shall, however, make the notification referred to in paragraph 1 if it considers that the measures are Necessary. (13/03/98)
If the medicinal product has a marketing authorisation or registration in more than one Member State, the matter shall be dealt with in accordance with the provisions of the Directive on the urgent procedure.
In cases where emergency measures are necessary for the protection of public health, the Agency may suspend and prohibit the placing on the market of the medicinal product concerned until the final decision is taken Made. Not later than the next working day, the Agency shall inform the European Commission, the European Medicines Agency and the other Member States of the reasons for such a measure.
The marketing authorisation, post-marketing authorisation and post-registration safety research carried out as a non-intervention study shall not be conducted if the conclusion of the study contributes to the use of the medicinal product. The health care professional shall be paid only for the time spent and the expenses incurred.
The Agency may require the marketing authorisation, co-import authorisation and registration holder to submit research plans and progress reports to the competent authorities of the Member State concerned, In whose territory the investigation is carried out.
The final report shall be made available to the competent authorities of the Member State in the territory of the Member State in whose territory the investigation is carried out, within 12 months of the end of the collection of the data. The marketing authorisation, parallel import licence and registration holder shall communicate new information that may affect the assessment of the risk-benefit balance of the medicinal product to the competent authorities of the Member State in which the medicinal product has been granted Marketing authorisation.
In addition to the provisions of Article 30m, the authorisation of a safety investigation pursuant to Articles 21 and 23c shall be subject to compliance with the provisions of this Article.
Prior to the conclusion of a safety study, the marketing authorisation holder and the parallel import authorisation holder shall submit a research plan to the Pharmacovigilance Centre, if the study is to be conducted only in Finland. Within 60 days of receipt of the research plan, the Centre shall decide on the establishment of a research plan or a ban on research. The investigation may be initiated only after the written confirmation by the Agency for the Safety and Development of Medicinal Products. The confirmation of the research plan depends on the fact that the study does not contribute to the use of the medicinal product, the design of the study meets the research objectives and the study is not a clinical trial.
Following the initiation of the investigation, any significant changes to the research plan shall be notified before their implementation to the Agency for Safety and Development. The Agency shall assess the changes and inform the marketing authorisation holder of their confirmation or objection.
After completion of the investigation, the final study report shall be submitted to the Pharmaceuresponsible Safety and Development Centre within 12 months of the end of the data collection, unless the Agency for the Safety and Development of the Medicinal Products Safety In writing of this exemption.
The marketing authorisation and the marketing authorisation holder shall assess whether the results of the study have an impact on the marketing authorisation and, where appropriate, submit an application for a marketing authorisation to the Medical and Development Centre.
Where research is carried out in more than one Member State, the research plan, significant changes to the research plan and the final study report shall be submitted to the Pharmacovigilance Risk Assessment Committee, which shall decide on the Of the European Parliament and of the Council on the prohibition of the investigation, the approval of amendments and the release of the final report.
The marketing authorisation, the parallel import licence and the marketing authorisation holder shall immediately inform the Agency on its own initiative, on its own initiative, on the efficacy or safety of the medicinal product Withdrawal from sale or suspension of sales and suspected product defects in the manufacture of the medicinal product released from the pharmaceutical company. In addition, the marketing authorisation, parallel import licence and registration holder must notify the Centre of suspected or suspected falsified medicinal products.
The Agency for Safety and Development in the pharmaceutical sector can provide more detailed provisions on the notification of product errors and counterfeit medicines.
The Agency shall, without delay, provide a prior warning to all Member States and to all operators in the supply chain of national medicinal products in situations where a medicinal product is suspected to pose a serious public health The hazard and the product concerned has been first identified in Finland. If such medicinal products are found to have ended up in patients, the Agency for Safety and Development in the pharmaceutical sector shall, without undue delay, be informed.
The pharmaceutical company may sell or otherwise dispose of pharmaceutical products and its own medicinal products only to another pharmaceutical company, pharmaceutical wholesale, pharmacies, secondary pharmacies, military pharmacies, hospital pharmacies and the medical centre. In addition, medicinal products not provided for or prescribed for sale only from pharmacies may be sold and otherwise disposed of to retailers of these products.
The pharmaceutical company may sell or otherwise donate medicinal products and medicinal products to the university, higher education and scientific research institute for research activities. The pharmaceutical company must notify the Agency for Safety and Development in the pharmaceutical sector.
From Finland, medicinal products may only be supplied from the pharmaceutical plant to an operator who is legally entitled to obtain medicinal products from the pharmaceutical company in that country. (30.12.2013/1200)
Wholesale of pharmaceutical products Means any activity carried out professionally and in exchange for the purpose of:
(1) the receipt of orders for medicinal products and any provision other than those referred to in paragraph 2;
(2) the acquisition and possession of medicinal products for supply to pharmacies, social and health care units and other entities referred to in Articles 34, 35 and 88 of this Act; or
3) the export of medicinal products.
(30.12.2013/1200)Wholesale trade in medicinal products is not, however, in accordance with Article 38 of medicinal products and medicinal products for the population, the supply of medicinal products and medicinal products from pharmacies to another pharmacy or social and health care unit, The dispensing of medicinal products and medicinal products from the hospital pharmacy or the medical centre in accordance with Article 62, or marketing and invoicing by the marketing authorisation holder or his representative, which does not involve the holding of preparations, Distribution and storage.
Wholesale trade in medicinal products may only be carried out with the authorisation of the pharmaceutical safety and development centre. The authorisation shall be granted subject to the availability of appropriate facilities, equipment and equipment available to the applicant in order to maintain and ensure that the medicinal product is maintained and that the applicant has the necessary staff. I promise to attach conditions to the exercise of the operation. The Agency shall be responsible for taking information related to the authorisation of the European Medicines Agency to the database maintained by the Agency. (30.12.2013/1200)
The recognition and the period within which the application for authorisation has to be settled in accordance with the provisions of the European Economic Area shall be laid down by a decree of the Council of Ministers.
Wholesale trade must have a direct employment relationship with a responsible Director responsible for ensuring that the medicinal products sold by the pharmaceutical wholesalers comply with the requirements laid down in this Law or by the provisions adopted pursuant to it. And that pharmaceutical wholesalers comply with the provisions on the conservation, processing and labelling of medicinal products. The responsible Director shall also be responsible for the appropriateness of the pharmaceutical wholesale distribution.
The manager of a pharmaceutical wholesaler must be a licensed pharmacist. The responsible director shall not be at the same time as a responsible manager in another company which has been authorised to engage in a pharmaceutical wholesale trade. In addition, the responsible director shall not be a responsible manager in the pharmaceutical company of another company, or the pharmacist, the hospital pharmacist or the medical centre, the director of the military pharmacy, or the nurse or pharmacist of the pharmacy or secondary pharmacy. The responsibilities of the responsible Director may be laid down in more detail by a decree of the Government.
Wholesale trade shall immediately inform the Centre for Security and Development and, where appropriate, the marketing authorisation holder of the marketing authorisation holder of the wholesale trade or medicinal products which it identifies or suspects to be falsified.
The pharmaceutical wholesale trade may be sold or otherwise disposed of to the pharmaceutical company, the other pharmaceutical wholesalers, pharmacies, the secondary pharmacies, the military pharmacies, the hospital pharmacy and the medical centre, and the veterinary surgeon. In addition, medicinal products not provided for or prescribed for sale only from pharmacies may be sold and otherwise disposed of to retailers of these products. Where medicinal products are sold or otherwise disposed of outside the EU and EEA, it shall ensure that medicinal products are supplied only to an operator who is legally entitled to obtain medicinal products in the pharmaceutical wholesale market in that country. When selling or otherwise excluding from the EU and EEA medicinal products which have been received by wholesalers from outside the EU and EEA without being imported into the territory of the Union, the wholesale trade shall ensure that medicinal products are obtained Only persons authorised in that country or the right to supply medicinal products to wholesalers. (13/03/98)
In addition, pharmaceutical wholesalers may be sold or otherwise disposed of to the other trader for use in production for purposes other than medicinal products and for the universities referred to in Article 17 (1) (5), Higher education institutions and scientific research institutes for research activities. (41,2005/853)
When giving medicinal products to buyers referred to in paragraphs 1 and 2, the medicinal product shall be accompanied by a document containing the information on the medicinal product. The Centre for the Safety and Development of Medicinal Products may provide more detailed provisions on the information to be provided in the document and on procedures to ensure that pharmaceutical wholesalers ensure the legal right of suppliers and recipients of medicinal products which they distribute. The supply and reception of medicinal products. (30.12.2013/1200)
Transmission of medicinal products For all activities carried out in a professional and professional manner:
1) which relates to the sale or purchase of medicinal products, but which is not wholesale;
(2) does not include the physical treatment of medicinal products; and
(3) consisting of negotiations on behalf of a legal person or a natural person.
The supplier of authorised or registered medicinal products for human use shall have a permanent address within the territory of the European Union. The intermediary of medicinal products established in Finland shall notify the Centre for the Safety and Development of the Medicinal Products Agency prior to the commencement of operation. The Centre shall publish registered intermediaries on the Internet on its website. The Centre may provide more detailed provisions on the requirements for the transmission of medicinal products and the notification procedure, as well as the registration of intermediaries.
The mediator shall immediately inform the Pharmacovigilance and Development Centre and, where appropriate, the marketing authorisation holder of the medicinal products offered to the intermediary, the intermediary of which states or suspects falsified medicinal products.
Pharmaceutical products and pharmaceutical wholesalers can be provided free of charge to doctors, dentists, veterinarians, pharmacists, pharmacists, nurses and nurses from the medical centre for sample and on-call time. Medicinal products not provided for or prescribed for sale from pharmacies only shall be disposed of to the retailers of these products. (41,2005/853)
Medicinal product shall mean the lowest pack size of the medicinal product to be delivered free of charge from the pharmaceutical company or the pharmaceutical wholesaler for access to the medicinal product. The daily package is a special pack intended for the patient to be released free of charge for immediate treatment.
The decree of the Council of State may provide for more detailed provisions on the conditions and limits for the release of samples and on-call services. In addition, the Agency for Safety and Development in the pharmaceutical sector can provide more detailed provisions on the labelling, storage and monitoring of samples and on-call packages. (16/10/2009)
The pharmaceutical wholesale trade must be accompanied by an action plan and guidance to ensure that the distribution of the medicinal product can be effectively prevented, the supplied medical packaging will be traced and, if necessary, withdrawn from the market by the pharmaceutical safety and development centre The decision referred to in Article 101 or the person responsible for the medicinal product of the medicinal product or of the medicinal product has decided on its own initiative to suspend the distribution of the medicinal product.
The functioning of pharmaceutical wholesalers must comply with the good distribution practices of medicinal products based on the provisions of the European Communities. The Agency for Safety and Development in the pharmaceutical sector may provide more detailed provisions on the good distribution of medicinal products for pharmaceutical products.
Wholesale trade must include lists of the import, purchase, storage and sale of medicinal products. Those lists shall be kept for at least five years. The contents and storage of the list may be further specified by the Government Decree.
Wholesale trade must seek to ensure that it has an equivalent number of medicinal products for sale.
The wholesale price of the medicinal product must be the same for all pharmacies and secondary pharmacies. The wholesale price shall take into account all discounts, takeovers and other benefits for pharmacies and secondary pharmacies. The wholesale price shall be reported to those who maintain the price of the medicinal products. These wholesale price restrictions do not apply to wholesale prices of medicinal products which may also be sold outside pharmacies.
By way of derogation from paragraph 1, a reduction in the supply of medicinal products to the performing medicinal product shall be reduced by a medicinal product used for dispensing dispensing with the list of eligible medicinal products referred to in Article 57c and in the Health Insurance Act. (1224/2004) in Chapter 6, Section 18 Of the reference price group. The reduction shall be allowed if the fixed reference price changes and the medicinal product used at the time of entry into force is more expensive than the new reference price. The reduction may be given for a maximum of 30 days after the change in the reference price. (8 MAY 2009)
For the purposes of this law:
(1) Pharmacies The pharmaceutical unit for the retail sale, distribution and manufacture of medicinal products and advisory and service activities relating to medicinal products;
(2) Side pharmacies A separate branch of the pharmacy, which is responsible for the activity of the pharmacist;
(3) At the pharmacy service station A separate office operated by the pharmacist, which may be sold for medicinal products;
(4) At the pharmacy service Selling medicinal products on the basis of an order made by the customer via the internet;
(5) In the pharmacy store The practice of pharmacies in a pharmacy, a side pharmacy, a pharmacy service station or a pharmacy service; and
(6) Pharmacist A person who has been granted authorisation to keep the pharmacy.
Medicinal products may be sold to the general public only from a pharmacy, a secondary pharmacy, a pharmacist and a pharmacist. However, traditional herbal medicinal products and homeopathic products referred to in Articles 22 and 22a may also be sold elsewhere, unless the Centre for Safety and Development in the pharmaceutical sector has decided otherwise. In addition, nicotinic products may also be sold elsewhere, as provided for in Article 54a below.
There should be pharmacies in the country in such a way that the population, if possible, can make it difficult to obtain medicines.
Pharmacy traffic may be carried out with the permission of the Agency for Safety and Development in the pharmaceutical sector ( Pharmacy licence ). The pharmacy authorisation shall be granted for the practice of a particular pharmacy in the municipality or part thereof. The pharmacy traffic should not be carried out anywhere other than in this law, at a pharmacy, a side pharmacy, a pharmacy pharmacy and a pharmacy in the pharmacy.
The pharmacy credit may be included in order to ensure the availability of medicinal products for the purposes of pharmacies' opening hours or to the maintenance of a side pharmacy and a pharmacy pharmacy.
At the request of the Agency for the Safety and Development of the Pharmaceutical Centre, the municipality is responsible for assessing the functioning, location and adequacy of the pharmacy services in the area. The municipality may submit a proposal to the Centre for the creation of a pharmacy, a side pharmacy and a pharmacy, to change the location or transfer them.
The establishment of a new pharmacy in the municipality or part thereof will be decided by the Agency for Safety and Development in the pharmaceutical sector as required by the availability of medicines. The decision shall be taken on the initiative of the Centre itself or by the municipality concerned. When assessing the availability of medicinal products, account must be taken of the population in the region, pharmacy services already in the region and the location of other healthcare services. The Centre may also decide to change the location of the pharmacy and transfer the pharmacy from part of the municipality to another if it is necessary to safeguard pharmacy services.
The Centre for the Safety and Development of Medicine may decide to abolish the pharmacy if the availability of medicines no longer requires the maintenance of the pharmacy population, pharmacy services already in the region and other health services Taking. The withdrawal decision shall not be implemented until the pharmacy licence in question has become open, unless the pharmacist has indicated that he will agree to the decision.
The Agency shall consult the municipality concerned before taking a decision as referred to in paragraphs 2 or 3.
The University of Helsinki has the right to hold one pharmacy in Helsinki and the University of Eastern Finland at one pharmacy in Kuopio. In addition to the sale of medicines, these pharmacies are responsible for carrying out research in the field of pharmacy teaching and medical care.
The pharmacist referred to in paragraph 1 shall be a licensed pharmacist. The pharmacy should be notified to the Agency for Safety and Development in the pharmaceutical sector.
The pharmaceutical safety and development centre shall declare a new or open pharmacy licence to be applied for. At the same time, the conditions of pharmacies referred to in Article 40 (2) shall be made public.
The pharmacy authorisation may be granted to a licensed pharmacist. In addition, the condition is that he has not been declared bankrupt, he has not been assigned a trustee and his capacity is not limited.
The pharmacy authorisation shall be granted from more than one applicant to the person who, as a whole, may be considered to be best placed to carry out a pharmacy. The assessment of the conditions shall take into account the applicant's activities in the pharmacy and other medical activities, including the date of entry into force of any previous pharmacy licence, and relevant to the exercise of the pharmaceutical product Studies, management and other activities.
The pharmacy license is personal. The pharmacy should not be rented or given to another. If a pharmacist gets a new pharmacy licence, the pharmacy license granted to him previously will stop at the same time.
The pharmacist shall itself manage the pharmacy, unless otherwise provided in this Act. In the case of illness or other specific reasons, the pharmacist may leave the pharmacy to the licensed pharmacist or licensed pharmacist for a maximum period of not more than three months per year.
If a pharmacist has been prevented from attending a pharmacy for more than three months due to illness or other specific circumstances, he/she shall inform the medical and development centre of the pharmacist or pharmacist who has prescribed For the duration of the pharmacy.
If, in the circumstances referred to in Article 46, the pharmacist is obliged to conduct a pharmacy in two pharmacies, the pharmacist shall assign a nurse to another pharmacies and inform the Medical Centre for Safety and Development.
Pharmacists are allowed to practice pharmacies until the age of 68.
The pharmacist shall, in the case referred to in Article 44 (1) and in the case referred to in Article 45 or dispense with pharmacies, carry out a pharmacy traffic until a new pharmacist has taken control of the pharmacy.
The pharmacist or side pharmacist of the pharmacy or side pharmacist shall redeem the pharmacy and secondary pharmacies for the current price of the pharmacy.
The pharmacy authorisation shall be deemed to have lapsed if the pharmacist has not introduced a pharmacy licence within one year from the decision to grant the pharmacy authorisation, and the Agency for the Safety and Development of the Medicinal Products Safety and Development has not granted The extension of the deadline.
Where there are reasonable grounds for suspecting that a pharmacist is unable to take care of the pharmacy himself or to deal with the availability of pharmacies himself, the Agency may, in order to find out: Be subject to medical examination or any other necessary clarification.
A pharmaceutical safety and development centre may prohibit a pharmacist temporarily from treating a pharmacy or part of other pharmacy activities if it is suspected to be unable to treat a pharmacy within the meaning of paragraph 1; or To the availability of pharmacy services. The prohibition may be issued at a time for a maximum period of one year or until the question of his incapacity has been finally settled.
The pharmaceutical safety and development centre shall withdraw the pharmacist if the pharmacist:
(1) declare bankruptcy and, within one year of the start of the bankruptcy, will not regain control of its assets;
(2) declare a disabled person;
(3) lose the right to act as a licensed pharmacist;
(4) as a result of illness or substance abuse or drug abuse, the profession of pharmacies cannot be properly pursued;
(5) become permanently incapable of treating the pharmacy as a result of sickness or other reasons;
(6) sentenced to imprisonment for a period of at least two years;
(7) fundamentally misuses the rights of pharmacists;
(8) receive written warning as referred to in Article 51 rather than correcting the procedure;
(9) is otherwise manifestly inappropriate to practice pharmacies.
If the pharmacist, acting as a pharmacist, has acted in contravention of any of the provisions or provisions adopted pursuant to this law or in his or her duties, has otherwise been negligent or negligent or incorrect or incorrect Or the fact that he or she should be prosecuted before a court, the Centre for Security and Development in the pharmaceutical sector may give him an oral or written warning.
The Agency may establish a secondary pharmacy on its own initiative or on the initiative of a municipality or a consortium of municipalities. In addition, the Agency for Safety and Development in the pharmaceutical sector may establish a side pharmacy and authorise the pharmacist's application. The granting of authorisation is conditional on the need to provide pharmacies in the area in order to secure access to medicines, and there are no adequate conditions for an independent pharmacies. The centre may authorise a pharmacist for a maximum of three secondary pharmacies.
The Agency shall decide on the site of the secondary pharmacy. The Centre may, on its own initiative or on the initiative of the municipality, the consortium or branch of the branch, amend the site provided for by the branch to ensure the availability of medicinal products.
By way of derogation from the provisions laid down in paragraph 1, the University of Helsinki may, with the permission of the Agency for Safety and Development in the pharmaceutical sector, hold up to 16 pharmacies.
The branch must have a pharmacist responsible for the activity prescribed by the pharmacist, who must be a pharmacist or pharmacist. An alert shall be submitted to the Agency for the Safety and Development of the Medical Service.
The opening hours of the site and the range of medicines may be less than pharmacies, provided that the local medical requirements allow it.
If the pharmacist has been authorised to hold a side pharmacy, a branch shall be administered by the pharmacist as a pharmacist or pharmacist as referred to in Article 46, or a pharmacist as referred to in Article 59, until a new pharmacist has taken Control of the pharmacy. Thereafter, a new pharmacist will be allowed to treat a secondary pharmacy until the matter of the side pharmacy is finally resolved and the pharmacist to whom the authorisation has been granted takes up a side pharmacy.
The Centre for the Safety and Development of the Pharmaceutical Centre may lay down provisions for the procedure to be followed in applying for a branch.
The apothecary may establish, on the basis of the authorisation given by the Agency for the Safety and Development of the Pharmaceutical Centre, an aptea shop area or village centre where there are no adequate operating conditions for the maintenance of the secondary pharmacy. A dedicated service point may also be established elsewhere to secure access to medicines. The entry point may be set up in or adjacent to the territory of the municipality. The application for authorisation shall be accompanied by a plan for the organisation of the medical advice provided for in Article 57 (2) below. The Centre shall grant an authorisation if the conditions laid down in this Article are met.
The apothecary must look after the service ramp inspection.
The Centre for the Safety and Development of the Pharmaceutical Sector may change the pharmacy side as a side pharmacy if the service station's turnover is half of the average turnover of the private branches of the country and the operating conditions of the secondary pharmacy are otherwise fulfilled.
The Agency for the Safety and Development of the Pharmaceutical Centre may lay down provisions on the application of the authorisation and on the activities of the service, the premises, the choice of medicinal products, the treatment and inspection.
Pharmacists of the University of Helsinki or the pharmacy of the University of Eastern Finland cannot establish a pharmacy service.
Pharmacist, pharmacist at the University of Helsinki and the pharmacy of the University of Eastern Finland can also provide assistance to the pharmacy services via the online service. The website of the network service provider should be available on the website. The pharmacy service with the support of the pharmacy must ensure that the marketing of the medicinal product is legal in the country to which the medicinal product is sold. The provision of a pharmacy network service shall be subject to prior notification to the Agency for Safety and Development in the pharmaceutical sector. The advance notification shall be accompanied by a plan for the organisation of the medical advice provided for in Article 57 (2) below. If the Centre has not requested further clarification of the facts referred to in this paragraph, or prohibited the commencement of the activity, the action may be initiated. The Centre shall be informed of the initiation, termination and material changes. If the conditions laid down in this Article are not met, the Centre may prohibit its activities or provide for the termination of the network service. (30.12.2013/1200)
Medicinal products subject to medical prescription may only be provided by the pharmacy network in accordance with (2011) By means of an electronic prescription.
The Agency shall maintain and maintain, publicly available on the internet, an up-to-date list of legal pharmacies. The website of the pharmacy network should be a link to the list maintained by the Centre. In addition, the website of the pharmacy network shall have a clearly visible common logo within the meaning of Article 85c of the Medicinal Products Directive. Information on national legislation applicable to the provision of medicinal products for distance marketing through the Internet, including information that medicinal products are available on the Internet, shall be available on the website of the Agency. Classification and their terms of delivery may differ between Member States of the European Union. In addition, the website should contain information about the purpose of the common logo, as well as background information on the risks of medicines to be supplied illegally by means of information society services. (30.12.2013/1200)
Otherwise, the pharmacy services will be subject to the consumer protection law. (38/1978) in Chapter 6 Provides for distance selling. The provisions on the online network of pharmacies also apply to the sale of medicines through other means of distance communication. The Centre for the Safety and Development of Medicinal Products may lay down provisions on the content and the conclusion of prior notification, as well as on network services, premises, technical implementation, pharmaceutical selection, treatment and inspection.
The Centre for the Safety and Development of Medicine may decide to turn the pharmacy into a secondary pharmacy where the pharmacy authorisation for that pharmacy has become open. The Centre for the Safety and Development of the Medicinal Products shall grant authorisation for the maintenance of the side pharmacy referred to in this case to the pharmacist, which, taking into account the location and operating conditions of the pharmacy he has maintained, is sufficient to maintain a secondary pharmacy.
If the turnover of the side pharmacy referred to in Article 52 (1) is so large that it corresponds to at least half of the average turnover of private pharmacies in the country, the Centre for Security and Development in the pharmaceutical sector may convert the secondary pharmacy to a pharmacy.
Where a pharmacy is less than a secondary pharmacy, the Centre for the Safety and Development of the Medicinal Products for Safety and Development may award the pharmacy authorisation referred to in paragraph 1, which was previously used as a side pharmacy, to be submitted separately, without declaring it To a pharmacist whose side pharmacy it has worked.
The decision referred to in paragraph 1 as a pharmacy shall not be converted into a pharmacy until five years after the establishment of the secondary pharmacy.
By way of derogation from Article 38a, nicotinic products may also be sold in retail shops, kiosks and service stations and in food stores on the basis of the retail marketing authorisation granted by the location of the place of sale. Nicotinic products may only be sold to persons aged 18 and over. The seller must be able to control the purchase situation. The sale of automatic sales orders shall be prohibited. (10.12.2010/1112)
If the applicant has the conditions to store and sell nicotinic products in accordance with this law, a municipality shall grant an authorisation for the sale of nicotinic products. The application shall contain the following information:
(1) the name of the applicant or the name and contact details of the Community, the company and the Community logo and the addresses of the place of sale of nicotine products;
(2) a report on the storage and marketing of nicotine products;
3) the name and contact details of the sale; and
(4) the number of points of sale at the place of sale of nicotine products and a description of their location.
The authorisation for the retail sale of nicotinic preparation shall be notified to the municipality of the change in the information reported in the application for authorisation. The municipality shall notify the granting of the authorisation and the termination of sales to the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
In the storage, retail, marketing, marketing, marketing and pharmacovigilance activities carried out by the Centre for the storage of nicotinic preparations in pharmacies, lateral pharmacies and medicinal cabinets, Comply mutatis mutandis with what is otherwise provided for in this Act for the storage, sale, control and pharmacovigilance activities carried out by the Centre for Security and Development in the Pharmaceutical Sector. However, Articles 55 and 55a, Article 56 (1) and Article 57 shall not apply to the sale provided for in this Article. (16/10/2009)
In addition, the control of the retail sale of nicotinic preparations in pharmacies, lateral pharmacies and medicine cabinets must comply with the provisions of the Law on tobacco Article 14 of the Sixth Directive Paragraph 4 provides.
The municipality shall, on its own initiative and on the basis of declarations made, verify the storage and sale of nicotine products and control the sale of nicotinic products.
Where an inspection or otherwise fails to act in contravention of this law or of any provisions adopted pursuant to it, the municipality shall prohibit its activities and set a time limit within which it must be stopped.
If the action has not been remedied within the prescribed period, or where the prohibition in the prohibition has been extended or renewed after the prescribed period, the municipality may withdraw nicotine products for a limited period or Completely.
The municipality may levy a fee for the retail marketing authorisation of nicotinic products from the applicant. In addition, the municipality may charge the retail marketing authorisation holder with the annual control fee for control measures. The authorisation and control fee may not exceed the cost of producing performance. The criteria for the retail licence fee and the control fee are laid down in more detail at the rate approved by the municipality.
Payments under this Article may be levied without a judgment and a decision in the order in which taxes and charges are collected by the law on the enforcement of taxes and charges (367/1961) Provides.
L-Law on the levying of taxes and charges 367/1961 Has been repealed by L for the implementation of taxes and charges 706/2007 .
For nicotinic preparations for retail sale and the content of the application for authorisation can be further adjusted by the Government Decree.
The Agency for the Safety and Development of Medicinal Products may provide that nicotine products sold for retail sale must be accompanied by separate instructions for use. Where appropriate, the Agency shall lay down provisions on the content of the guidelines.
The pharmacy shall keep the appropriate number of medicinal products and equipment and bandages necessary for its normal customer base. (22.11.1996/82)
The pharmacy and the branch shall be kept open in such a way as to ensure the availability of medicinal products. The pharmacist shall inform the municipality of the opening hours at which the pharmacy is located. (8.3.1993/248)
The apothecary shall contribute to ensuring that the medicinal products supplied from the pharmacy, the side pharmacy, the pharmacy pharmacy and the pharmacy services are of a quality quality and that the sale or disposal of the medicinal product is Appropriate authorisation. (10.12.2010/1112)
Pharmacies may act as competent authorities within the meaning of Article 75 of the Schengen Convention, which may issue the certificate referred to in that Article with medicinal products containing narcotic drugs or psychotropic substances To travel from one Contracting State to another.
The pharmacy and the secondary pharmacy must have a necessary number of pharmaceutical graduates. The apothecary must ensure that the full staff of the pharmacy are adequately involved in continuing training. This training shall take into account basic training and work assignments of staff.
The facilities for the pharmacy, the side pharmacy and the pharmacy should be suitable for the sale and storage of medicinal products. The premises used for the manufacture and testing of medicinal products must be suitable and equipped for this purpose.
The pharmacy supplies the medicinal product intended for human use in another European Union or in a State belonging to the European Economic Area or in Switzerland ( European prescriptions) , if the medicinal product prescribed by a European prescription is to be marketed in accordance with the medicinal products directive or the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, the prescriptions comply with the requirements of this Act and the provisions adopted pursuant thereto.
The pharmacy may refuse to supply a medicinal product prescribed by a European prescription where there are reasonable grounds for suspecting the authenticity of the prescription or the medical appropriateness of the prescription, or if the prescription is unclear or incomplete.
The provisions of paragraph 1 shall not apply to medicinal products that require a special medical prescription as referred to in Article 71 (2) of the Directive.
Medicines should be provided with advice and guidance from pharmacy and pharmacist to ensure that the user is aware of the correct and safe use of the medicinal product. In order to verify. In addition, information on the price of medicinal products and other factors affecting the choice of medicinal products should be provided to the purchaser. The marketing authorisation for a medicinal product to be delivered must include information at the time of delivery of the medicinal product actually cheapest. (20.3.2015)
L to 253/2015 Paragraph 1 shall enter into force on 1 January 2016. The previous wording reads:
Medicines should be provided with advice and guidance from pharmacy and pharmacist to ensure that the user is aware of the correct and safe use of the medicinal product. To ensure. In addition, information on the prices and other aspects of the choice of medicinal products should be provided to the purchaser.
The pharmacist, the pharmacist at the University of Helsinki and the University of Eastern Finland must ensure that the purchaser has access to pharmaceutical Advice and guidance on the correct and safe use of medicinal products, information on the prices of medicinal products and other factors affecting the choice of medicinal products. Medicinal products to be supplied on the basis of a prescription for a pharmacy may only be supplied by a pharmacist or pharmacist.
The Centre for the Safety and Development of Medicinal Products may lay down rules on procedures for the delivery of medicinal products from pharmacies, secondary pharmacies, a pharmacy service point and an online pharmacy.
The pharmacy and the branch shall keep a list of prescriptions per calendar year. The list shall include information on the medicinal product supplied and its quantity, the drug user or the institution for which the medicinal product is prescribed and the prescriber. The list shall be kept for five years. The list shall be drawn up and maintained, as specified by the Agency for Safety and Development in the pharmaceutical sector.
When acting on the prescription of a medical practitioner, a medical practitioner or a medical practitioner entitled to prescribe a medicinal product, a medicinal product is to be replaced by a medicinal product in general available in Article 57c. Of the list referred to in the list, which is the cheapest price or the price difference between the lowest price:
(1) a maximum of EUR 1,50 for a preparation of less than EUR 40; or
(2) EUR 40 or more shall not exceed EUR 2.
(21.5.2010 /435)On the basis of the first day of each quarter, on the basis of the cheapest product or the reference price group, the cheapest price is defined at the time of the first day of each quarter, in the case of the cheapest preparation of the reference price group. The retail price of value added tax. (5.12.2008)
However, the exchange shall not be carried out if the prescriber of the medicinal product has prohibited the exchange on the basis of medical or therapeutic indications, by imposing a prohibition on the prescription or if the buyer of the medicinal product prohibits the exchange. In the case of prescription, the same product should be supplied. However, if a prescription is provided on a number of occasions, the purchaser of the medicinal product is entitled to purchase a medicinal product in accordance with a prescription. In addition, the purchaser of a medicinal product is always entitled to have the right to obtain the cheapest alternative medicinal product at the time of delivery, unless the prescriber has prohibited the exchange on the basis of medical or therapeutic reasons.
The Agency should draw up a list of eligible medicinal products. Medicinal products whose active substances and quantities are similar and which are biologically equivalent, may be defined as alternatives.
The Pharmacovigilance Centre shall publish the list referred to in paragraph 1 at the latest 45 days before the start of each quarter.
The Regulation of the Ministry of Social Affairs and Health may, where appropriate, provide that the marketing authorisation holder must declare the prices of eligible medicinal products at least 21 days before the first day of each quarter of the social and The Authority under the authority of the Ministry of Health and the information on the price of medicinal products to other entities regularly maintained. In addition, a ministerial decree may provide for an authority to publish a list of eligible medicinal products and their prices.
The retail price of the medicinal product shall be used for the price of the medicinal rate provided for by the Council Regulation. In accordance with Article 37a of the marketing authorisation holder of the medicinal product, the price for the medicinal product must be based on the national wholesale price, which is calculated on the basis of the wholesale price, and the value added tax. On the basis of the wholesale price, the calculation of the product may be lower than that of the pharmacy (148/1946) The rate of contribution to be determined.
Paragraph 1 shall not apply to medicinal products which may also be sold outside pharmacies, lateral pharmacies and medicine cabinets.
If necessary, the rate of the medicinal product shall be reviewed. The pharmaceutical safety and development centre shall provide the Ministry of Social Affairs and Health annually with information on the sales margins of pharmacies and other matters affecting the rate of medicinal products. (16/10/2009)
In addition to the provisions of Article 38a on the activities of pharmacies, pharmacies and a branch may also engage in other service activities in the field of health and welfare promotion and disease prevention. The purpose of the action shall not be to increase the unnecessary use of medicinal products.
Where a pharmacy or a branch is sold other than medicinal products other than those provided for in paragraph 1, the sale or operation shall not interfere with the provision of medicinal products and medicinal products related to medicinal products.
In the event of a pharmacist's death or withdrawal of pharmacist's licence, the pharmaceutical safety and development centre will determine who is to be treated by the pharmacy until a new pharmacist has taken over the pharmacy. In the case referred to in Article 49, the Agency shall also determine the safety and development centre of the pharmaceutical sector. The pharmacist shall apply mutatis mutandis to the pharmacist as provided for in this law. (16/10/2009)
In the cases referred to in paragraph 1, only a licensed pharmacist may be appointed under his own responsibility. However, a legal pharmacist may be prescribed for a maximum period of two months at a time.
More detailed provisions on pharmacies and on the application for authorisation, as well as the pharmacy, side pharmacy, pharmacy and online service, their activities and facilities, the eligibility conditions for the pharmacy and the pharmacist, as well as pharmaceutical staff As well as the content and number of complementary training, where appropriate, by a decree of the Council. (10.12.2010/1112)
In addition, the Agency may provide more detailed provisions on the facilities, facilities and equipment necessary for the storage, manufacture and testing of medicinal products. (16/10/2009)
There may be a hospital pharmacy for its operation in the hospital. There may be a hospital pharmacy or a medical centre at a hospital or health centre maintained by a municipality, a consortium of municipalities and a state. (9.8.2002/700)
The Agency, as referred to in paragraph 1, may also be set up under the Law on Private Health (152/90) And the Law on the Special Care of Persons with Disabilities, maintained by the service provider (519/77) , if required by the number of registered nurses. (8.3.1993/248)
A hospital pharmacy or a medical centre may be set up with the permission of the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
The premises of the hospital pharmacy and the medical centre must be suitable for the supply, storage, preparation and testing of medicinal products. They must also be properly equipped. (9.8.2002/700)
The application for authorisation, as well as the premises of the hospital pharmacy and the medical centre, shall be laid down, where appropriate, by a decree of the Government. (9.8.2002/700)
In addition, the Agency may provide more detailed provisions on the activities of the hospital pharmacy and the medical centre, good manufacturing practices and premises, facilities and facilities for the storage, manufacture and testing of medicinal products. Equipment. (16/10/2009)
Notwithstanding the provisions of Article 61, a hospital pharmacy or a medical centre maintained by a municipality or a consortium may:
(1) medicinal products for the purposes of public social and health care units within the territory of the same municipality or by the municipality or any of the municipalities adjacent to them;
(2) communicable diseases Article 25 of the 583/1986 To private social and health care units within the territory of the same municipality or by the municipality or any of the municipalities adjacent to them;
(3) medicinal products other than the social and health care units and pharmacies referred to in paragraph 1, in order to ensure the necessary medical treatment of a patient in situations where there are problems with the availability of medicinal products; and
(4) medicines for the use of a peacekeeping force outside Finland.
(13.1.2006/22)With the permission of the Centre for the Safety and Development of the Pharmaceutical Centre, medicinal products may also be provided from the hospital pharmacy and the med centre to the private social and health care units with which the municipality or group of municipalities has concluded an agreement On the purchase of social and health care services for social and health planning and the provision of State aid (733/1992) In accordance with paragraph 1 (4), or which exercise other functions under the law to the municipality or to the State. (29 DECEMBER 2009/1727)
The Centre for the Safety and Development of Medicinal Products may, for a specific reason, authorise the supply of medicinal products in a manner derogating from paragraph 1 and the release of the medicinal product imported in accordance with Article 14 and Article 17 (1) (4). To another social and health care facility and a pharmacy. (16/10/2009)
The decision to grant the authorisation of the Agency for the Safety and Development of Medicine, as referred to in this section, must ensure that the availability of medicinal products in the region is not significantly hampered. Before granting an authorisation, the Agency shall consult the pharmacist in the area where the granting of the authorisation may have an effect. The content of the application for authorisation and the granting of authorisation may be laid down in more detail by a decree of the Government. (16/10/2009)
A list of the procurement of medicinal products and the provision of medicinal products in accordance with Article 62 shall be kept at the hospital pharmacy and the medical centre. That list shall be kept for at least five years. The Agency for the Safety and Development of Medicinal Products may provide more detailed provisions on the preparation of the list and the information to be included and the maintenance of the list.
There's gonna be a nurse at the hospital pharmacy and the med center. The nurse shall be responsible for the operation of the hospital pharmacy or the medical centre and the medical services of the relevant unit, in accordance with this law and the provisions adopted pursuant thereto. (13.1.2006/22)
The nurse in the hospital pharmacy must be a licensed pharmacist and a licensed pharmacist or certified pharmacist.
At the hospital pharmacy and the medical centre, the necessary medicines may be released free of charge for the suspension of the treatment of a patient who is temporarily transferred from a hospital or health centre or temporarily transferred to an outpatient patient. In the case of a patient who has received a hospital polyclinic or a health centre, the consideration may be given free of charge to start treatment until he can reasonably be expected to receive them, taking into account the local circumstances. From the pharmacy. In addition, the patient may be extradited free of charge to the necessary medicinal products for the treatment, reimbursement and maintenance treatment of drug addicts. The medicines to be released and the conditions for donation are laid down in more detail by a decree from the Ministry of Social Affairs and Health.
In addition, the hospital pharmacy and the medical centre may be extradited free of charge to the healthcare system (1326/2010). And the medicinal products used for the prevention and prevention of pregnancy, as referred to in Article 26. Similarly, free of charge may be provided by the infectious disease Article 25 of the 583/1986 And the Law on Customer Charges for Social and Health Care (734/1992) Medicinal products referred to in paragraph 4. (30.12.2010/1340)
The Centre for the Safety and Development of Medicinal Products may lay down more detailed rules on procedures for the release of the medicinal products referred to in this Article. (16/10/2009)
The Centre for the Safety and Development of Medicine may suspend or revoke the authorisation referred to in Article 61, provided that the activities of the hospital pharmacy or the medical centre are essential in accordance with this law, permit conditions or good manufacturing practice for medicinal products. , or seriously jeopardise the safety of medicinal products, or where no action has been taken in accordance with the provisions of Article 78.
The activities organised by the municipality pursuant to this Chapter shall be governed by the law on social and health planning and the State share, unless otherwise provided for.
Military pharmacies may be established for the defence of the military. The creation of a military pharmacy is regulated in more detail by a decree of the Government.
Medical centres can be set up for medical care in prisons. The establishment of a medical centre for prisons is regulated in more detail by a decree of the Council of Ministers. (13.1.2006/22)
Chapter 8 is repealed by L. 26.11.1993/1046
The Ministry of Social Affairs and Health is responsible for the general planning, supervision and control of the medical service.
The Centre for the Safety and Development of Medicinal Products shall ensure that preclinical safety studies of medicinal products are conducted in accordance with good laboratory practice and shall be authorised by the laboratories to be approved as a testing laboratory.
The Agency may attach conditions and restrictions to the approval of the laboratory. More detailed provisions on the authorisation procedure are laid down by the Ministry of Social Affairs and Health Regulations.
The authorised testing laboratory shall inform the Agency of the essential changes taking place in its activities.
The Agency may withdraw the approval of a testing laboratory if the laboratory does not comply with the conditions for approval or does not comply with the conditions, restrictions or orders imposed on its operation.
The Agency shall ensure that manufacturers of medicinal products and medicinal products, medicinal products for clinical trials in clinical trials, medicinal products for advanced therapy medicinal products The patient-making units, contract manufacturers and analysers, laboratories, pharmaceutical wholesalers, pharmaceutical wholesalers, pharmacists, pharmacies, hospital pharmacies, medical centres and medical centres, and A military pharmacy is checked as often as Adequate pharmacovigilance is required. In addition, the Centre may check the pharmacovigilance and premises of the pharmacy, the marketing authorisation holder of the pharmacy, the marketing authorisation and the use of medicinal products for the manufacture of medicinal products. Manufacturers of excipients. The Agency may carry out inspections in accordance with agreed cooperation with the European Medicines Agency.
If necessary, the inspection may be carried out without prior notice. The inspector shall be allowed access to all premises of the establishment which are not used for permanent housing. The inspection shall include all documents requested by the inspector necessary for the purpose of carrying out the inspection. In addition, the inspector shall be provided free of charge with copies of the documents necessary for the carrying out of the inspection, together with samples of the substances and preparations in the office separately for examination. The inspector also has the right to take image recordings during the inspection.
The inspection shall be maintained. Prior to the adoption of the Protocol, the Agency shall provide the subject of the inspection with an opportunity to issue an opinion on the audit findings. In particular, the examination of the matters to be taken into account and the precise content of the verification procedure, as well as the Protocol and its preservation and retention period, shall be governed by the Council Regulation.
The Centre for the Safety and Development of Medicinal Products shall issue a certificate of good manufacturing practice or good means of distribution to the pharmaceutical company subject to inspection, if requested, if it can be concluded that the factory Or wholesale trade complies with the principles and guidelines of good manufacturing practice or good distribution practice as laid down in European Union law. The Centre for the Safety and Development of Medicine shall be responsible for taking certificates of good manufacturing practice or good distribution methods to the database maintained by the European Medicines Agency.
The marketing authorisation holder of a veterinary medicinal product shall, at the request of the Agency for Safety and Development, provide advice and guidance for the purpose of carrying out certain substances and residues thereof in live animals and products thereof. A laboratory designated under the provisions of Council Directive 96 /23/EEC on control measures and repealing Directives 85 /358/EEC and 86 /469/EEC and Decisions 89 /187/EEC and 91 /664/EEC and repealing Decisions 89 /187/EEC and 91 /664/EEC The analytical method used.
The inspector may lay down provisions to remedy any identified deficiencies. As a result of a provision which may have been issued, it is necessary to take the necessary measures without delay.
Article 79 has been repealed by L 7.8.2015/1039 , which enters into force on 1 January 2016. The previous wording reads:
The order in the examination referred to in Article 77 shall not be subject to appeal. The dissatisfaction of the order shall be the right to make a request to the Medical and Development Centre for the correction of the decision. The order shall be accompanied by instructions to refer it to the Agency for Safety and Development in the pharmaceutical sector. Despite the need for a correction, measures must be taken in accordance with the provisions. (16/10/2009)
The objection referred to in paragraph 1 shall be filed in writing within 30 days of the end of the inspection and shall indicate:
(1) the name of the complainant;
(2) an order for which an adjustment is sought;
(3) to what extent an adjustment is sought and an adjustment required for it; and
4) the grounds for the appeal.
The adjustment requirement shall be signed by the author or by the author.
The request for adjustment shall be accompanied by evidence to which the complainant wishes to rely and which have not been submitted earlier.
The Agency for the Safety and Development of Medicinal Products may order the cessation of the manufacture of medicinal products for the time being, if the inspection or otherwise shows any defects that jeopardise the proper manufacture of medicinal products or if the provisions adopted pursuant to Article 78 No action has been taken.
The Agency for Security and Development in the pharmaceutical sector may suspend or revoke the authorisation of a pharmaceutical wholesale trade if it has materially acted in contravention of this law or of the terms of the authorisation or otherwise seriously jeopardises the No action has been taken in accordance with the provisions adopted pursuant to Article 78.
§ 81 has been repealed by L 4.11.2005/853 .
Customs control compliance with the import rules under this Act.
The Pharmaceutical Safety and Development Centre shall confirm the relevant pharmacopoeia.
The Agency for Safety and Development in the pharmaceutical sector may, if necessary, adopt additional provisions for the pharmacopoeia that it has established.
The Agency shall, every three years or, where appropriate, more frequently establish a list of medicinal products, which shall be drawn up in the light of Articles 3 and 5.
Wild plants or parts of plants collected from a home country or abroad, which are listed in the list of medicines, must be sold as such if the Centre for Safety and Development in the pharmaceutical sector has not expressly prohibited it.
The Agency shall be authorised to import, distribute and sell immunological veterinary medicinal products for the prevention or detection of serious animal diseases if the product is not otherwise available in Finland or Resistance to animal diseases otherwise requires. The action shall comply with the provisions of Articles 35a and 36 concerning the exercise of the pharmaceutical wholesale trade.
Notwithstanding the provisions of Articles 17 and 21, a person entitled to a veterinary profession in a State belonging to the European Economic Area shall, notwithstanding the provisions of Articles 17 and 21, be brought and used in a veterinary medicinal product with a marketing authorisation in a country where He is primarily active in the profession and contains the same amount of the same active substance as the product obtained by the marketing authorisation in Finland. The Decree of the Council of State lays down more precise conditions for the import of veterinary medicinal products, the maximum quantity of the medicinal product imported, the supply of a medicinal product to the owner or holder of the veterinary medicinal product, and the use of medicinal products Records and storage of documents.
Pharmacies, including the pharmacy of the University of Helsinki and the pharmacy of Kuopio University, and manufacturers of pharmaceutical products and pharmaceuticals, are carrying out a review of the marketing surveillance of medicinal products and pharmaceuticals in the pharmaceutical sector. Two thousandths of the difference in the sale and purchase price of medicinal products for the development centre ( Quality control fee ). In the case of pharmacies, the corresponding sales margin shall be reduced before the fee is issued by the pharmacy fee. The pharmaceutical manufacturers make a payment for the sale of the goods without the intermediation of the pharmaceutical wholesaler directly to the pharmacy or to any other person entitled to purchase.
Each year, the Agency shall establish a fee referred to in paragraph 1 and shall have the right to obtain the information necessary for the calculation of the fee. The Agency shall provide more detailed provisions for the recovery of the charge.
The Pharmaceutical Safety and Development Centre may issue medicines for export to pharmaceutical companies, medicinal products for clinical medical research units, pharmaceutical wholesalers and the authorities of the exporting country Certificates for medicinal products and their manufacture.
Clinical medical research refers to an intervention study on human beings for humans and the absorption, distribution, metabolism or excretion of the medicinal product in the human body.
Clinical trials shall be carried out in accordance with the law on medical research (488/1999) Provides. In addition, account must be taken of what is provided for in this law and, on that basis, clinical trials.
The initiation of clinical trials on medicinal products for gene therapy, somatic cell therapy or xenogenic cell therapy and the initiation of clinical trials on medicinal products containing genetically modified organisms requires a medical and safety centre The authorisation granted. Other clinical trials shall be subject to prior notification to the Centre.
The investigation may be initiated following the adoption by the Ethics Commission of the favourable opinion referred to in Articles 3 and 10c of the Law on Medical Research and the Agency for the Safety and Development of Medicine, (2), or has informed the sponsor of the request for prior notification that there is no obstacle to the initiation of an investigation or, if the Centre has not filed such a notification, within 60 days of the date on which the The Centre has received an appropriate prior notification.
The Agency shall adopt its decision on medicinal products for gene therapy or somatic cell therapy and for the initiation of clinical trials on medicinal products containing genetically modified organisms Within 90 days of receipt of a valid application. The Centre may extend the period by 90 days if the submission of an opinion requires extensive further clarification. There is no time limit for a decision on csenogenic cell research. However, the decision must be taken without undue delay.
If the Agency for Safety and Development in the pharmaceutical sector is not in a position to accept an application for authorisation or prior notification, an additional report shall be requested from the sponsor. The request for further clarification shall identify and justify all the reasons for which the investigation cannot be carried out in accordance with the research plan. On the basis of the request of the Agency for Security and Development in the pharmaceutical sector, the Executive Officer may amend its research plan to address the shortcomings identified. If the applicant does not modify his/her advance notification or request for authorisation or changes to the Centre's request for further clarification, the clinical trial should not be initiated.
The Agency shall provide more detailed provisions for the application of the authorisation referred to in paragraph 2, the content of the application and the prior notification and the quality and manufacture of the research medicinal products, the safety of the investigations and the Adequate implementation, notification of adverse reactions and other matters of relevance to the safety of the studies.
If the study plan for clinical trials is amended so that the change can affect the safety of the subjects or change the interpretation of the scientific documents used in support of the study, or if the change is otherwise significant, Shall be notified to the Agency for Safety and Development in the pharmaceutical sector. The study shall not continue in accordance with the amended plan before the Ethics Commission has given its favourable opinion and the Centre for Safety and Development in the pharmaceutical sector has indicated that the plan for the continuation of the investigation Is not an obstacle or, in the absence of such notification, 35 days after the date of notification.
If the Centre for Safety and Development in the pharmaceutical sector does not accept the amendment of the research plan, the mandate shall be notified to the contractor to verify the necessary amendments. The investigation may continue after these and any changes required by the Ethics Commission have been made or, alternatively, to continue the investigation in accordance with the original plan, unless the safety of the investigation requires a study Suspension or termination.
The Agency's role is to monitor clinical trials. Without prejudice to the confidentiality rules, the Centre shall, if necessary, verify the accuracy of the information collected in the investigation, including the place of examination, the research documents and the persons under investigation. Patient documentation. Inspections shall also be subject to Articles 77, 77a and 78 to 80.
If a pharmaceutical safety and development centre has reasonable grounds to consider that the sponsor, investigator or other person related to the investigation no longer fulfils the obligations imposed on him, the Centre shall inform the relevant The contractor, the examiner or any other person, and shall present an action plan to remedy the situation. The Centre shall immediately inform the Ethics Commission and the competent authorities of the Member States of the European Union and the Commission of this plan.
The Centre for the Safety and Development of Medicine may temporarily suspend or terminate the clinical trial already started if the study is not carried out in accordance with the research plan or the conditions under the research plan Are no longer in force, or where the investigation does not comply with the conditions laid down in the Law on Medical Research, or in accordance with the provisions or provisions adopted on the basis of that law.
Before issuing a provision referred to in paragraph 1, the Agency shall consult the sponsor or the investigator. The contractor and the investigator shall provide the report requested by the Centre within seven days. Where there is an imminent threat to investigate, the Centre may order the investigation to be suspended immediately. On the basis of the immediate danger, the termination of the suspended investigation shall not be decided until after consultation of the sponsor or examiner in accordance with the above.
The Agency shall immediately inform the Commission, the European Medicines Agency and the competent authorities of the Member States of the European Economic Area, of the prescription it has issued, The authorities and the relevant ethics committees. The notification shall be accompanied by the reasons for the provision given.
The Agency shall be responsible for providing information on clinical trials to the European Agency for the Evaluation of Medicinal Products. The data to be stored may be laid down by a Council Regulation.
In the pharmaceutical company, medicinal products for clinical trials, pharmaceutical wholesalers and pharmaceutical wholesalers, as well as pharmacies, may be released to the doctor and to the dentist in order to perform the study with the necessary medicines.
Clinical trials on veterinary medicinal products shall be subject to prior notification to the Agency for Safety and Development in the pharmaceutical sector. The Centre shall monitor clinical veterinary investigations and may, where appropriate, verify the facts necessary to verify the accuracy of the data collected in the investigation, including the place of examination and the research documents.
Where appropriate, the Agency may prohibit the initiation of an investigation referred to in paragraph 1 if the investigation does not comply with the conditions laid down in this law or in accordance with the provisions or provisions adopted on that basis. The Centre may temporarily suspend or terminate a clinical veterinary investigation which has already been initiated, provided that there have been material deficiencies or omissions in the conduct of the investigation and have not been corrected by the Centre. Despite.
Before issuing the order referred to in paragraph 2, the Agency shall consult the sponsor or the investigator. The contractor and the investigator shall provide the report requested by the Centre within seven days. Where the order is based on an imminent threat to an investigating animal, the Centre may order the investigation to be suspended immediately. On the basis of a direct risk, the termination of the suspended investigation shall not be decided until after consultation of the sponsor or the examiner as provided for above.
The decree of the Council of State may provide for the period of notification referred to in paragraph 1 and the procedures and time limits for the suspension of the investigation. The Agency may lay down provisions on the notification referred to in paragraph 1, the quality and production of research medicinal products, the safe and proper conduct of investigations, the reporting of adverse effects, and Other matters of relevance to the safety of investigations.
Pharmaceutical plant, medicinal product for clinical trials, pre-clinical safety studies of medicinal products, contract analysis or contract preparation by a pharmaceutical manufacturer or a laboratory, Pharmaceutical wholesale, marketing authorisation or registration holder, pharmacist, pharmacist at the University of Helsinki, the pharmacy of the University of Eastern Finland, the pharmacy and the medical centre, advanced therapy medicinal products for a single patient The manufacturer of the manufacturing unit and the military assistance shall, if requested, To provide the Medical Safety and Development Centre with information and surveys on the import, manufacture, inspection, distribution, sale or other consumption of medicinal products without prejudice to the confidentiality rules; Which are necessary for the performance of the tasks laid down in this or other law.
The pharmaceutical product, as well as the investigator referred to in Article 2 (4) of the Medical Examination Act, and the employer referred to in paragraph 5 of the Medical Examination Act, shall, upon request, provide medical safety and The Centre for the Evaluation of Medicinal Products, without prejudice to the confidentiality provisions of the Centre, which are necessary for the Centre in accordance with the provisions of this Law and of the Law on Medical Research, Is carried out.
The Agency shall inform the Commission, the European Medicines Agency and the competent pharmacovigilance authorities of the Member States of the European Economic Area, without prejudice to the confidentiality rules, and Record in the databases maintained by the European Medicines Agency all information obtained in the context of pharmacovigilance and pharmacovigilance, which is required by European Community legislation to be notified to those bodies or to be recorded in the European Database operated by the Agency.
The Social and Health Authorisation and Control Agency, the Institute for Health and Welfare and the Social Insurance Institution shall be obliged, upon request, to provide, free of charge, to the Agency for the Safety and Development of the Medical and Development Centre, in accordance with the , without prejudice to the obligation of professional secrecy. Without prejudice to the confidentiality provisions of the Ministry of Social Affairs and Health, the Agency shall, without prejudice to the request of the Medical Safety and Development Centre, inform the Centre of the right to self-employment of a healthcare professional An impact which may have an impact on the granting or validity of an authorisation under this law. Without prejudice to the provisions of confidentiality, the National Pensions Office shall, without prejudice to the request of the Agency for Safety and Development, inform the Centre on matters relating to pharmacies and pharmacists who may have an impact on this The granting or the validity of a legal authorisation.
The pharmacist or his assistant shall not unlawfully divulge such a private or family secret from which he or she has been informed.
Law on public authorities' activities (18/09/1999) Notwithstanding the obligation of professional secrecy, the Agency may disclose the information it receives from the private or Community trade or professional secret to the institution of the European Union in the performance of its duties under this law; and To the other surveillance authority, as required by the acts of the European Community, and to the Food Safety Agency, the Ministry of Social Affairs and Health, the Pharmaceutical Price Board, the People's Pensions Office and the Police, Customs and To the prosecuting authority where it is necessary for their To carry out the tasks. (16/10/2009)
In the case of medicinal products, the appropriate use of the medicinal product should be encouraged. Information on marketing shall be consistent with the information contained in the authorised summary of product characteristics.
The marketing of medicinal products must not attract the population to unnecessary use of the medicinal product, gives an erroneous or exaggerated image of the composition, origin or medicinal function of the product, or other similarly inappropriate. Only medicinal products within the meaning of this Act may be advertised or marketed. The marketing of a medicinal product which does not have a valid marketing authorisation or registration in Finland is prohibited.
In addition to the provisions of paragraphs 1 and 2, the consumer protection law is in force. (38/1978) Is regulated by marketing regulations.
The population shall not be marketed with medical prescription or medicinal products containing narcotic drugs or psychotropic substances. The marketing of the population shall include at least the name of the medicinal product and the generic name, if the medicinal product contains only one active substance, the information necessary for the correct and safe use of the medicinal product, and A specific and easily readable invitation to read carefully the separate instructions for use. However, the exception is the marketing of the medicinal product. In the case of a reminder marketing, only the name of the medicinal product, its international name or trade mark, and also the holder of a marketing authorisation or registration, shall be mentioned. (41,2005/853)
Paragraph 2 has been repealed by L 4.11.2005/853 .
Advertising must not contain any unjustified health claims or target children. The advertising of medicinal products must not be exaggerated or misleading for the effects of the medicinal product.
The distribution of medical samples to the population for promotional purposes is prohibited.
Medicinal products referred to in Article 91a (1) may also be marketed to persons entitled to prescribe or supply a medicinal product. Such marketing shall only take place in the pharmaceutical presentations and publications intended for the prescribing or dispensing of the medicinal product and in electronic media. Electronic marketing must be carried out in such a way as to ensure that it cannot be applied to the sideline.
The advertising of medicinal products to persons entitled to prescribe or supply the medicinal product shall contain the essential information on the medicinal product and its use. However, the exception is the marketing of the medicinal product. In the case of a reminder marketing, only the name of the medicinal product, its international name or trade mark, and also the holder of a marketing authorisation or registration, shall be mentioned. (41,2005/853)
The marketing authorisation holder or any other medicinal product marketing authorisation holder or any other medicinal product should keep a publicly available up-to-date list of direct and indirect financial or other comparable aid which it has provided: Associations and patient organisations active in the medical and health field.
Promotions of medicinal products for health workers and veterinary surgeons, such as benefits and gifts, must be of minor economic importance and be related to their professional activities. For sales promotion events, hospitality must be reasonable and secondary to the purpose of the event and must not be extended to other than healthcare personnel. Sales promotion activities must not be inappropriate or unsuitable to be considered to undermine the confidence of the public in the independence of prescription, use or disposal of medicinal products. The hospitality provided for purely professional or scientific purposes shall always be at a reasonable level and remain subsidiary to the scientific purpose of the meeting and shall not be extended to: Non-healthcare professionals.
Persons having the right to prescribe or supply medicinal products shall not request or accept any incentives, benefits or gifts which are prohibited under paragraph 1 or are otherwise contrary to it.
The restrictions on marketing laid down in Articles 91 to 92 may be regulated in more detail by a decree of the Council of State.
The Agency will monitor the appropriateness of the marketing of medicinal products. For the purpose of monitoring, the marketing and advertising of medicinal products must be submitted to the Centre for the Safety and Development of the Pharmaceutical Centre by means of the reports and declarations provided by the Government decree on marketing and advertising. (16/10/2009)
The Social and Health Authorisation and Control Agency and the Regional Administrative Agencies should ensure that the law on health professionals (559/1994) Shall comply with the prohibition laid down in Article 92 of the healthcare professionals who are entitled to prescribe or supply medicinal products. This supervision is otherwise provided for by the law on health professionals. (22/09/1546)
Where the marketing of a medicinal product has been carried out in contravention of the provisions of Articles 91, 91a, 91b or 92 or Article 92 (a), the Agency may prohibit the continuation or renewal of marketing. The Centre may also impose a marketing adjustment if it is deemed necessary for the sake of the safety of the medicinal product. The Centre may order the publication of the list referred to in Article 91c within the time limit set by it.
The prohibition and the provision to correct marketing or to publish a list can be made more effective by periodic penalty payments. Where appropriate, a new penalty payment may be imposed in order to enhance the effectiveness of the prohibition or provision.
The periodic penalty payment imposed by the prohibition or order shall be rejected by the Administrative Board at the request of the Agency for Safety and Development in the pharmaceutical sector.
The Agency may also take the measures referred to in Article 93 (1) and (2) of the Law on the (1189/2000) , if the activities of Finland are contrary to Council Directive 92/28/EEC or Member States concerning the advertising of medicinal products for human use The provisions of Article 14 of Council Directive 89 /552/EEC on the coordination of laws, regulations and administrative provisions, as implemented at national level in the future law.
The periodic penalty payment imposed pursuant to paragraph 1 shall be rejected by the periodic penalty payment penalty imposed by the Regional Administrative Agency on application by the Agency for Safety and Development in the pharmaceutical sector or by a foreign authority or organisation.
The right of the Agency to initiate an injunction in another State belonging to the European Economic Area provides for a law on cross-border linguistic arrangements.
The marketing authorisation of a medicinal product and the registration holder of a traditional herbal medicinal product shall have a scientific service unit responsible for the information to be provided on the marketing of the medicinal product.
By way of derogation from the provisions of this Act concerning the sale of medicinal products from a pharmaceutical company or a pharmaceutical wholesaler, the manufacturer or importer of a medicinal product may, after obtaining the authorisation referred to in Article 8 or 32, sell medicinal gas to the patients concerned. And the needs of the medical transport. The Agency for Safety and Development in the Pharmaceutical Sector may provide more detailed provisions on procedures for the supply of medicinal gas.
Articles 95a to 95c have been repealed by L 16.5.2014/388 .
The penalty, contrary to this law or the provisions on the control of medicinal products within the meaning of this Act, or the provisions adopted pursuant thereto, or the provisions of the medicinal product for medicinal products adopted pursuant to them, shall be governed by the provisions of (39/1889) Article 44 (5) .
Penalty for the operation of pharmaceutical wholesalers and pharmacies without authorisation under this law Article 3 of Chapter 44 of the Penal Code .
Penalty for breach of the obligation of professional secrecy laid down in Article 90 Chapter 38 of the Criminal Code 1 or 2, if the act is not punishable Article 5 of Chapter 40 of the Penal Code Or otherwise, the law provides for a heavier penalty.
Every intention or negligence on the part of this law or of a regulation pursuant to Articles 95 or 308 of the Treaty establishing the European Community on the supervision of this law or of medicinal products, or of a general or individual case Contrary to the order
(1) manufacture, import, store, store or dispose of medicinal products within the meaning of this Act;
(2) fails to comply with the notification, obligation or list of medicinal products referred to in this Act;
(3) is in breach of the prohibition on medicinal products referred to in this Act by the Finnish supervisory authority or by the Commission of the European Communities or by the Council of the European Union;
(4) violates the provisions of this law on the marketing of the medicinal product; or
(5) request, approve or receive any incentives, benefits or gifts prohibited by Article 92;
Shall be condemned, unless the law provides for a heavier penalty in the rest of the law, On the drug offence Fine.
The criminal offence is also punishable by the failure to comply with the rate of the medicinal product referred to in Article 58 intentionally or negligently.
Article 99 has been repealed by L 26.10.2001/893 .
§ 100 has been repealed by L 24.5.2002/411 .
The Agency shall have the right to prohibit the import, manufacture, distribution and sale of the medicinal product, as well as any other release for consumption, if it occurs or there is reason to suspect that the conditions for granting or registering a marketing authorisation no longer exist. Or where the requirements and obligations relating to the manufacture or importation of the medicinal product have not been fulfilled.
The Agency shall have the right to prescribe the distribution, sale and other release for consumption of the medicinal product for the purpose of suspension and withdrawal from the market, including where there are reasons to suspect that the medicinal product has been falsified or Product error. (30.12.2013/1200)
The Centre for the Safety and Development of Medicinal Products may suspend or revoke a marketing authorisation for the pursuit of the manufacture or wholesale of medicinal products where a requirement relating to the granting of a permit is no longer satisfied or if any The obligation to provide safety or quality is not fulfilled.
In the case referred to in Chapters 4, 40, 49, 50, 52, 59, 59, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 80, 93, 101 and 101a, an appeal may be lodged in respect of the award of the pharmacy licence Administrative law, as in the case of administrative law (18/06/1996) Provides.
The decision referred to in paragraph 1 of the Agency for the Safety and Development of the Medicinal Products Safety and Development Centre and the Order referred to in Article 78 may require an adjustment from the Agency for Safety and Development in the pharmaceutical sector, as referred to in the Administrative Act (2003) Provides. The decision on the request for adjustment shall be subject to appeal by the administrative court as provided for in the administrative law.
In the case referred to in Article 29 (2), Article 29 (2), 49, 50, 66, 80, 80a, 87c, 88 (a), (88), (88), (93), (93) and (101a) of the Administrative Court, an appeal may be lodged under the terms of the administrative law. An appeal against any other decision of the administrative court may be lodged only if the Supreme Administrative Court grants an appeal.
The Agency shall have the right to appeal against the decision of the Administrative Court.
The decisions referred to in Article 2 (4), (4), (6), (23c), 30 l, 30, 59, 66, 80, 80a, 80 (a), 87, 8c, 88 (c), 88 (c), (88), (87), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (93) and The appeal authority decides otherwise. Decisions under Articles 40, 41, 52 and 54 of the Centre shall not be implemented until they have received the force of the law.
L to 1039/2015 Article 102 shall enter into force on 1 January 2016. The previous wording reads:
The decision to be adopted by the Agency for the Safety and Development of Medicinal Products under this Act shall be amended in accordance with the law on administrative law (18/06/1996) Provides. The decision of the Administrative Court, which has closed the case referred to in Articles 40, 41, 52 or 54, may be appealed against by the Supreme Administrative Court only if the Supreme Administrative Court grants an appeal. The decision on administrative law relating to the obligation to provide information within the meaning of Article 89 shall not be subject to appeal.
An authorisation may be granted if:
(1) in other similar cases or in conformity with the case-law, it is important to refer the matter to the Supreme Administrative Court;
(2) there is a specific reason for bringing the matter to the Supreme Administrative Court for reasons of manifest error; or
(3) there is another reason for the granting of an authorisation.
The Centre for Security and Development in the Pharmaceutical Sector shall also be entitled to appeal against the decision of the administrative court if the administrative court has resolved the matter under appeal.
The decisions referred to in Article 2 (4), 23 (c), 30 n, 59, 66, 80, 80a, 87 (c), 88 (c), 88 (c), 88 (c), 88 (c), 88 (c), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), (88), Decisions under Articles 40, 41, 52 and 54 of the Centre shall not be implemented until they have received the force of the law. (3.5.2013/330)
Without prejudice to the administrative law (2003) Provides for the correction of a factual error, the Agency for the Safety and Development of Medicinal Products may remove the authorisation of the medicinal product, the modification of the medicinal product and the withdrawal of the authorisation granted, or the prohibition of the withdrawal of the medicinal product The decision and redecision if the decision of the institution of the European Union so requires.
Notwithstanding the provisions of the Administrative Act for the correction of a factual error, the Agency for the Safety and Development of the Medicinal Products Agency may withdraw the authorisation, modification of the medicinal product and withdrawal of authorisation or consumption of the medicinal product. The decision on the prohibition of extradition and the re-examination of the case if the decision of the institution of the European Union so requires.
L to 1039/2015 Article 102a enters into force on 1 January 2016.
More detailed provisions on the implementation of this law are laid down by the Government Decree.
This Act shall enter into force on 1 January 1988.
This law repeals the Law of 4 January 1928 on the pharmacy (4) And apothecary law of 5 December 1935 (374/35) With their subsequent modifications.
Before the entry into force of the law, measures may be taken to implement it.
The person who, when the law enters into force, is authorised to manufacture pharmacies to be sold for sale or who is authorised to carry out the trade in pharmacies, shall continue to be entitled, without the authorisation provided for in this law, to manufacture medicinal products in the pharmaceutical company. Or the wholesale trade in medicinal products. However, the new authorisation referred to in Articles 8 and 32 of this Act must be applied within three years from the date of entry into force of this Act, otherwise the prior authorisation shall be deemed to have lapsed.
The person who, when the law enters into force, has the right to engage in pharmacies in a pharmacy or a secondary pharmacy, is still entitled to that same right.
A municipality or a consortium of municipalities which, in a hospital maintained at the time of entry into force of this Act, is authorised by the Government to hold a special pharmacy, shall, without a separate authorisation, continue to hold a medical pharmacy within the meaning of this Act. Without prejudice to the provisions of this Law, a municipality or association of municipalities which, at the time of entry into force of this law, is authorised to manufacture and distribute medicinal products in accordance with the law on pharmacies, may continue to manufacture and distribute medicinal products. The medical centre of the medicinal product centre, dispenses medicinal products from the medical centre referred to in this Act. A private medical facility and a development disability institution which, at the time of entry into force of this Act, is authorised to manufacture and distribute medicinal products, may continue to distribute medicinal products from the pharmaceutical centre referred to in this Act.
A special medicinal product which is authorised for sale or otherwise for consumption in accordance with the entry into force of this Act, may continue to be sold or released for consumption in Article 20 of this Act. Medicinal product. Such a product shall otherwise be subject to the provisions of this Act.
Products for which the authorisation granted pursuant to Article 10f of the Pharmacy Act for the sale or otherwise of release for consumption is valid at the time of entry into force of this Act and preparations for which it is expressly provided for: The authorised medicinal product intended for use, may continue to be sold to the public as medicinal products within the meaning of this Act.
At the time of entry into force of this Act, the rate and pharmacopoeia of the latter shall continue to be observed until a new rate of medicinal and pharmacopoeia has been established by virtue of this law. The medical board shall, no later than one year after the entry into force of this Act, establish a list of medicinal products, until the date of expiry of the list of pharmacies for pharmacies.
Upon entry into force of this Act, the case pending before the provincial government, the medical board or the Ministry of Social Affairs and the Ministry of Social Affairs and Health shall be dealt with and resolved upon entry into force of the law. In accordance with the provisions in force.
HE 87/86, tv miet. 13/86, svk.M. 272/86This Act shall enter into force on 1 March 1991.
HE 233/90, sosvkms. 44/90, svk.Met. 227/90
This Act shall enter into force on the date of the Regulation.
On the occasion of the entry into force of the Act, pending the entry into force of the law, pending the entry into force of the Act, the provisions of Article 21 (1) (4) and Article 26 (1), with the exception of the provisions in force, shall be taken into account. An application for modification of the price of the authorised product must be submitted to the social and health government.
Before the law enters into force, measures may be taken to implement the law.
THEY 118/92 , StVM 30/92, SuVM 5/92
This Act shall enter into force on 1 January 1994.
Before the entry into force of this Act, measures may be taken to implement it.
THEY 171/93 , StVM 19/93
1. This Act shall enter into force on the date of the Regulation.
2. Repeal the Act of 27 November 1992 amending the Medical Act (182/92) .
3. When the law enters into force, pending the entry into force of the law, the provisions of Article 21 (1) (4) and Article 26 (1) (1), according to which: An application for modification of the price of the authorised medicinal product shall be submitted to the medical establishment and the provisions of Chapter 8.
4. The conditions laid down in paragraphs 1 and 2 of Article 21a (1) and (2) of this Act comply with the conditions laid down in Article 69 (1) or Article 10 (f) of the Pharmacy Code concerning homeopathic and anthroposophic products: The authorisation is valid at the time of entry into force of this Act, to be entered into as registered products within the meaning of Article 21a of the law at the time of entry into force of the law.
5. Other products other than those mentioned above in respect of which the authorisation granted under Article 69 (1) or Article 10f of the pharmacy guarantee is valid at the time of entry into force of this Act, and products thereof, For which the medicinal product is intended to be authorised for use as a medicinal product for which the medicinal product is authorised, to be entered as authorised medicinal products for use as herbal medicinal products within the meaning of Article 21 (2) of this Law By means of uses.
6. The labelling of the products listed in accordance with the above mentioned above shall be completed within two years of the entry into force of this Act, in accordance with Articles 21a and 30 of the Pharmaceutical Institution and the The provisions of Article 30.
Notwithstanding the provisions of Article 24 (1) on the period of validity of the marketing authorisation and the renewal of the marketing authorisation, the medicinal product shall determine the period during which the marketing authorisation holders of medicinal products authorised in accordance with the Apply for renewal.
8. In the course of the year following the entry into force of this Law, herbal preparations and homeopathic and anthroposophic preparations in Finland shall be subject to an application for authorisation as referred to in Article 8 of the Pharmaceutical Code.
9. Wholesale traders of medicinal products referred to above shall, within one year from the entry into force of the law, apply for authorisation or recognition within the meaning of Article 32.
10. Before the entry into force of this Act, measures may be taken to implement it.
Annex II to the EEA Agreement: Council Directives (65/6 5/EEC, 75 /318/EEC, 75 /319/EEC, 87 /21/EEC, 81 /851/EEC, 81 /852/EEC, 85 /432/EEC and 91 /356/EEC), THEY 101/93 , StVM 29/93
This Act shall enter into force on 1 April 1995.
Before the entry into force of this Act, measures may be taken to implement it.
THEY 337/94 , StVM 52/94 Council Regulation (EEC) No 2309/93; OJ L 214, 24.8.1993, p. 1, Council Directive 93 /39/EEC; OJ L 214, 24.8.1993, p. 22, 93 /40/EEC, OJ L 214, 24.8.1993, p. 31, 81 /851/EEC; OJ L 317, 6.11.1981, p. 1
This Act shall enter into force on 1 September 1995.
THEY 94/93 , LaVM 22/94, SuVM 10/94
This Act shall enter into force on 1 May 1996 and shall expire on 31 December 1996.
By way of derogation from the law of the municipalities (688/92) Article 4 And Article 6 (1) provides for an increase in the number of additional costs incurred by municipalities in the social and health care sector in 1996.
THEY 13/96 , StVM 5/96, EV 35/96
This Act shall enter into force on 1 January 1997.
The provisions on the location of the pharmacy and the conditions attached to the pharmacy law pursuant to Article 43 (3) of the Pharmaceutical Code that the obligation to hold a branch pharmacy shall cease to be valid no later than three years after that date From the date of entry into force of the law, in the case of a medical establishment, within the meaning of Article 40 of this Act, where the pharmacy must be located. If the condition referred to in Article 43 (3) of the Pharmaceutical Law is attached to a pharmacy in the municipality alone, the condition shall cease to be valid at the time of entry into force of this Act.
Before the entry into force of this Act, measures may be taken to implement it.
THEY 118/1996 , StVM 19/1996, EV 129/1996 Council Directive 83 /189/EEC; OJ L 109, 26.4.1983, p. 8, the others. 88 /182/EEC; OJ L 81, 26.3.1988, p. Seventy-five. 94 /10/EC; OJ L 100, 19.4.1994 p. 30
This Act shall enter into force on 1 January 1997 and shall expire on 31 December 1998. (11.12.1997-1135)
By way of derogation from the law of the municipalities (1147/1996) , the shares in municipal social and health care units for 1997 and 1998 are increased by the total amount of additional costs to be incurred by municipalities. (11.12.1997-1135)
THEY 167/1996 , StVM 25/1996, EV 143/1996
This Act shall enter into force on 1 March 1998.
THEY 124/1997 , StVM 15/1997, EV 129/1997
This Act shall enter into force on 1 January 1998.
THEY 175/1997 , StVM 25/1997, EV 198/1997
This Act shall enter into force on 1 January 1998.
THEY 175/1997 , StVM 25/1997, EV 198/1997
This Act shall enter into force on 1 April 1999.
Before the law enters into force, measures may be taken to implement it.
At the latest six months after the entry into force of this law, the University of Helsinki will release its branch to the University of Kuopio in Kuopio. The terms of the extradition shall be determined on the basis of an agreement between universities. If the contract has not been concluded by the date of delivery, the Council shall determine the terms and conditions of the release.
The University of Helsinki should grant permission to the University of Helsinki to set up a new 16-year-old branch of Kuopio's new branch no later than six months after the site of Kuopio has been handed over to the University of Kuopio. The site where the site is established should be located in the city of Espoo, Helsinki or Vantaa, which is well founded in the area of pharmacovigilance.
THEY 276/1998 , StVM 42/1998, EV 308/1998
This Act shall enter into force on 1 December 1999.
30/1998 , Case 31/1998, EV 303/1998
This Act shall enter into force on 1 January 2001.
THEY 178/2000 , TaVM 36/2000, EV 183/2000, European Parliament and Council Directive 98 /27/EC (31998L0027); OJ L 166, 11.6.1998, p. 51
This Act shall enter into force on 1 January 2002.
THEY 80/2000 , LaVM 14/2001, EV 94/2001
This Act shall enter into force on 1 September 2002.
THEY 17/2001 , LaVM 5/2002, No 35/2002
This Act shall enter into force on 1 January 2003.
This law repeals the Regulation of 23 December 1987 on veterinary access to veterinary medicinal products for veterinary use (185/1987) With its subsequent modifications.
Before the law enters into force, measures may be taken to implement it.
THEY 46/2002 , StVM 14/2002, EV
This Act shall enter into force on 1 March 2003.
THEY 146/2002 , StVM 32/2002, No 166/2002
This Act shall enter into force on 1 April 2003.
Before the law enters into force, measures may be taken to implement it. In the case of a medicinal product before the entry into force of the law, the medicinal product shall be exchanged in accordance with Article 57b, if the buyer wishes to have the medicinal product replaced by a cheaper product. The purchaser of a medicinal product must be informed, in accordance with Article 57, of the possibility of an exchange.
THEY 165/2002 , StVM 39/2002, EV 209/2002
This Act shall enter into force on 1 May 2004.
The provisions of this law shall apply mutatis mutandis to clinical trials pending before the entry into force of the law.
Before the law enters into force, measures may be taken to implement the law.
THEY 20/2004 , StVM 5/2004, EV 33/2004 Directive 2001 /20/EC of the European Parliament and of the Council (32001L0020); OJ L 121, 1.5.2001, p. Directive 2001 /83/EC of the European Parliament and of the Council (32001L0083); OJ L 311, 28.11.2001, p. 67-128
This Act shall enter into force on 7 November 2005. However, Article 17 (3) shall enter into force on 1 June 2006. The provisions of this Act shall apply to all applications for authorisation, registration, alterations and reform made on or after 30 October 2005.
Before the law enters into force, measures may be taken to implement it.
The marketing authorisation of the medicinal product authorised before the entry into force of this Act shall be renewed in accordance with this law. If the validity of the marketing authorisation expires within six months of the entry into force of this Act, an application for renewal may be made by way of derogation from the deadline laid down in Article 24 (2), at least three months before the expiry of the marketing authorisation. Where, at the time of entry into force of this Act, a valid marketing authorisation has been renewed once or more before the entry into force of the law, the Agency shall issue separate provisions on the explanations and documents accompanying such a renewal application.
If the medicinal product, which is a traditional herbal medicinal product as defined in Article 5a, is a marketing authorisation valid for the entry into force of this Act, the medicinal product shall be authorised by the Administration to amend it in accordance with Article 22. Registration. If a medicinal product as defined in Article 5a is classified as a food before the entry into force of this Act, the product must be registered by 31 December 2007 at the latest. Where registration has been requested by that date, the traditional herbal medicinal product referred to in this paragraph may be sold without registration until such time as the medicinal product has given its decision on the application. For a medicinal product which has been authorised as a medicinal product, but is not a traditional herbal medicinal product as referred to in Article 5a, a marketing authorisation under this law should be applied for the renewal of a marketing authorisation valid at the time of entry into force of the law.
A medicinal gas which is for sale upon entry into force of this Act and which does not have a marketing authorisation shall apply for a marketing authorisation by 31 December 2007 at the latest. Where an application for a marketing authorisation has been requested by that date, a medicinal product shall be sold without a marketing authorisation until such time as the Agency has given its decision on the application. However, the medicinal product may prohibit the sale of medicinal gas on the grounds mentioned in Article 101 of the Pharmaceutical Code before the decision on the application for a marketing authorisation has been adopted.
If the European Community has granted a marketing authorisation for a medicinal product for which an application for a marketing authorisation has been lodged on 19 November 2005 or before, the period referred to in Article 21a (1) shall be 10 years. For reference products based on a marketing authorisation application before the entry into force of this Act, the period shall be six years. Where an application for a reference product has been requested prior to the entry into force of this Act, Article 21a (2) to (4) shall not apply to the marketing authorisation of the generic medicinal product.
If a medicinal product has been authorised before the entry into force of this Act, a period of three years following the entry into force of this Act shall be calculated in accordance with Article 29 (1) (3).
The Veterinary and Food Research Institute, the Public Health Service and the Finnish Red Cross are authorised to import, manufacture and distribute medicinal products under the provisions in force at the time of entry into force of this Act until the end of 2007. Thereafter, the import, manufacture and distribution of medicinal products requires authorisation under this law. The import, manufacture and distribution of medicinal products by the Veterinary and Food Research Institute, the Public Health Institute and the Finnish Red Cross will be supervised in accordance with Article 77.
THEY 108/2005 , HVL 33/2005, StVM 17/2005, EV 124/2005, Directive 2001 /82/EC of the European Parliament and of the Council (32001L0082); OJ L 311, 6.11.2001, p. 1, Directive 2001 /83/EC of the European Parliament and of the Council (32001L0083); OJ L 311, 6.11.2001 p. Directive 2004 /24/EC of the European Parliament and of the Council (32004L0024); OJ L 136, 31.3.2004, p. Directive 2004 /27/EC of the European Parliament and of the Council (32004L0027); OJ L 136, 31.3.2004, p. Directive 2004 /28/EC of the European Parliament and of the Council (32004L0028); OJ L 136, 31.3.2004, p. 58
This Act shall enter into force on 1 February 2006.
Before the law enters into force, action can be taken to implement it.
Article 37a applies to pharmacies delivered after the entry into force of the law. However, Article 37a applies before the entry into force of the law before the entry into force of the law six months after the entry into force of the law.
If the medicinal product has been authorised before the entry into force of this Act and the marketing authorisation holder submits to the medicinal product within four months of the entry into force of this Act, Article 57c (2) (1) of the report referred to in Article 57c (2) (3) The validity of the patent or supplementary protection certificate referred to in paragraph 1, and not previously eligible, and its generic medicinal products shall be eligible for exchange in the case of a patent and a supplementary protection certificate. However, in spite of the validity of the patent or supplementary protection certificate, the products obtained by the different importers of the same medicinal product may be identified among themselves.
If the medicinal product and its generic medicinal products are eligible for the entry into force of this Act, the medicinal product shall be removed from the list of eligible products if the marketing authorisation holder presents within four months of the date of entry into force of this Act. In accordance with Article 57c (2) (3). The deletion shall be made in the drawing up of a list of eligible medicinal products for the preparation of a patent or supplementary protection certificate. However, in spite of the validity of the patent or supplementary protection certificate, the products obtained by the different importers of the same medicinal product may be identified among themselves.
THEY 107/2005 , StVM 32/2005 EV 196/2005
This Act shall enter into force on 1 May 2006.
THEY 203/2005 , MmVM 2/2006, EV 31/2006
This Act shall enter into force on 1 April 2007.
Before the law enters into force, measures may be taken to implement it.
THEY 250/2006 , StVM 43/2006, EV 216/2006
This Act shall enter into force on 1 April 2009.
By 30 January 2009 at the latest, the medicinal product shall publish the list of eligible medicinal products which will enter into force on 1 April 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 100/2008 , StVM 24/2008, EV 138/2008
This Act shall enter into force on 18 May 2009. However, Article 15c shall enter into force on 1 January 2010.
Before the law enters into force, measures may be taken to implement the law.
THEY 21/2009 , StVM 8/2009, EV 32/2009, Regulation (EC) No 1394/2007 of the European Parliament and of the Council (32007R1394); OJ L 324, 10.12.2007, p. 121, Directive 2008 /97/EC of the European Parliament and of the Council; (32008L0097); OJ L 318, 28.11.2008, p. 9
This Act shall enter into force on 1 November 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 74/2009 , StVM 21/2009, EV 96/2009
This Act shall enter into force on 1 November 2009. However, Article 15c shall enter into force on 1 January 2010.
Before the law enters into force, measures may be taken to implement the law.
THEY 166/2009 , StVM 28/2009, EV 122/2009
This Act shall enter into force on 1 January 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 161/2009 , HVM 18/2009, EV 205/2009
This Act shall enter into force on 1 January 2010.
THEY 174/2009 , HVM 19/2009, EV 223/2009
This Act shall enter into force on 1 July 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 283/2009 , StVM 2/2010, EV 32/2010
This Act shall enter into force on 1 October 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 180/2009 , StVM 14/2010, EV 102/2010
This Act shall enter into force on 1 February 2011.
Applications for authorisation before the entry into force shall be processed in accordance with the provisions in force at the date of entry into force of the law.
Pharmaceutical licences issued before the entry into force of this Act shall remain in force. After the entry into force of this Act, the medical license will no longer be renewed. However, an apothecary authorised for the maintenance of the medicine cabinet may apply to the pharmaceutical safety and development centre to replace the medicinal product authorisation holder with the authorisation granted to the pharmacist if provided for in Article 52a. The conditions are fulfilled. If the pharmacist changes, a new pharmacist will have to set up an aptea service to apply for the authorisation mentioned in Article 52a.
Before the law enters into force, measures may be taken to implement the law.
THEY 94/2010 , StVM 22/2010, EV 145/2010
This Act shall enter into force on 1 May 2011.
Before the entry into force of this Act, measures may be taken to implement it.
THEY 90/2010 , StVM 40/2010, EV 244/2010
This Act shall enter into force on 1 May 2012.
THEY 199/2010 , YmVM 23/2010, PeVL 58/2010, HVL 35/2010, TaVL 30/2010, EV 360/2010
This Act shall enter into force on 1 June 2013.
The renewal of the marketing authorisation of the medicinal product registered or authorised before the entry into force of this Act shall be governed by this law.
Sales and registrations granted before 21 July 2012 shall be the parent file required by Article 30d from the date of renewal of the marketing authorisation or registration, or from 21 July 2015, whichever is the earlier.
The Agency may, by decision, order the holder of a marketing authorisation or registration to introduce a risk management system for a medicinal product for which a marketing authorisation has been granted. Or registration before 21 July 2012. It is required that the Centre suspects that there are risks which affect the risk-benefit balance of the medicinal product authorised or registered. The marketing authorisation or registration holder shall provide the Centre with a detailed description of the risk management system it intends to introduce. Article 23c (4) and (5) shall apply to the procedure to be followed. The decision shall be taken in spite of the appeal, unless otherwise specified by the appeal authority.
The Agency may provide more detailed provisions for the submission of periodic safety update reports referred to in Article 30k, if the marketing authorisation or registration has been issued before 21 July 2012 and concerns such A marketing authorisation or registration issued only in Finland and has not been established as a reference date for the Union.
The Pharmacovigilance Centre shall verify and evaluate the pharmacovigilance system in accordance with Article 30b and report the results to the European Commission for the first time by 21 September 2013.
Before the law enters into force, action can be taken to enforce the law.
THEY 200/2012 , StVM 3/2013, EV 23/2013, Directive 2010 /84/EU of the European Parliament and of the Council (32010L0084); OJ L 348, 31.12.2010, p. 74-99
This Act shall enter into force on 1 January 2014.
THEY 155/2013 , StVM 17/2013, EV 134/2013
This Act shall enter into force on 1 January 2014.
THEY 183/2013 , StVM 30/2013, EV 206/2013
This Act shall enter into force on 1 December 2014.
THEY 98/2013 , MmVM 3/2014, EV 16/2014
This Act shall enter into force on 1 January 2016.
THEY 330/2014 , StVM 43/2014, EV 292/2014
This Act shall enter into force on 1 January 2016.
In the case of appeals before the entry into force of this Act, the provisions in force at the time of entry into force of this Act shall apply.
THEY 230/2014 , LaVM 26/2014, EV 319/2014
