Pharmaceutical Regulation

Original Language Title: Lääkeasetus

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Read the untranslated law here: http://www.finlex.fi/fi/laki/ajantasa/1987/19870693

Presentation by the Minister of Social Affairs and health, provided for in the law of 10 April 1987 on the medicine (395/87) on the basis of a medicinal product to be manufactured, importing and wholesale section 1 (22.10.2009/803) when applying for the security and development of the pharmaceutical sector in the Centre the medicine Act (395/1987) the authorisation referred to in article 8 for the manufacture of medicinal products is capable of industrial application is the application be accompanied by: 1 the articles of Association of the applicant) or an equivalent document, as well as the applicant, or in the case of a branch in Finland registered a foreign trader, a branch of the commercial register;
2) statement on pharmaceutical products, pharmaceutical ingredients and pharmaceutical forms, the factory is to be manufactured;
3) a statement of the estimated amount of the pharmaceutical factory, the production of medicinal products;
the location of the pharmaceutical factory and 4) a statement of the facilities as well as production and quality control of the equipment to be used;
5) with a report on the quality assurance of production;
of the staff, as well as the pharmaceutical factory 6) 7) a statement referred to in article 9 of the pharmaceutical under the responsibility of a Director and the eligibility of a qualifying person.
The authorization shall apply only to the safety of the pharmaceutical sector and the permit granted by the Centre for the development of the detailed medical or pharmaceutical substances. Other dosage forms or medicine manufacturing requires a change in the issued certificate. The appeal is to be lodged separately for security and development in the pharmaceutical sector. Change the application, mutatis mutandis, in accordance with paragraph 1 shall be included in the reports. If the medicinal product is made in the factory to the production of, or otherwise relating to the control of the quality of a material change, is this notification to the security and development of the pharmaceutical sector.
When applying for the security and development of the pharmaceutical sector in the Centre of the pharmaceutical law of the authorization referred to in article 8 in order to carry out the tasks related to the monitoring of the quality of medicinal products, the application shall be accompanied by a sopimusanalysointina is, mutatis mutandis, to the reports required under paragraph 1. The control unit performs the tasks of the quality of medicinal products or laboratory issued the authorization shall apply only to the safety of the pharmaceutical sector and the permit granted by the Centre for the development of the detailed analysis techniques. Variation and change in behavior of the applications and notifications shall apply mutatis mutandis with regard to what is provided for in paragraph 2.

Article 1 (a), (c-372/97/312) the control of the quality of medicinal products unit of carrying out the tasks of the sopimusanalysointina, and the Director of the laboratory's responsibility must be covered by the appropriate graduate degree, adequate experience of the analysis of the quality control, as well as otherwise, mutatis mutandis, to the medicine section 9(2) and (3) the required qualifications. If the functions of the unit and the laboratory is not part of the drug-approval of its assets, does not need to be in the medicine section 9(2) and (3) persons meeting the eligibility criteria referred to in.

2 section (22.10.2009/803) the authorisation referred to in article 32 of the laws of the Medicine in the field of security and Development Centre for the application be accompanied by: 1 the articles of Association of the applicant) or an equivalent document, as well as the applicant, or in the case of a branch in Finland registered a foreign trader, a branch of the commercial register;
2) a statement of the estimated distribution of the pharmaceutical wholesale trade, the scale of the drug;
3 the location of the pharmaceutical wholesale trade) and the premises, as well as devices and instruments;
4 wholesale trade) with a report on the medical staff;
5) report on the arrangements for the transport of medicinal products;
6) with a report on the treatment of medical materials, and quality control;
7) with a report on the drug from the responsibility referred to in article 33 the President; as well as 8) a statement referred to in Article 7a of this regulation, the contingency plan.
In the State of the European economic area, in accordance with the provisions of the community pharmaceutical wholesaler granted to the holder of the authorization, who wants to follow the pharmaceutical wholesale business in Finland, will be in addition to the States, accompany the application to the members of the European economic area, the settlement of the second issue.
If I change the behavior of the pharmaceutical wholesale trade, essentially, is to submit a notification to the security and development of the pharmaceutical sector.

2. (a) section (c-372/97/312) 8, 15 (a), or the authorisation referred to in article 32 of the application must be resolved within 90 days of the date of the arrival of the application for authorisation, the safety and the development of the pharmaceutical sector. (22.10.2009/803)
Section 1, 2, and 3 an application for amendment of the authorisation as referred to in sub-section must be resolved within 30 days of receipt. Change in the processing of the application may be for a specific reason, which shall be notified to the applicant before the expiry of the period referred to above, to continue for up to 60 days.
An additional study on the transmission or the provision of an explanation of the time are not included in those referred to in article editing.

section 3 (22.10.2009/803) Pharmaceutical Factory, drugs in clinical medicine research unit, as well as producing medicines quality control unit of carrying out the tasks of the sopimusanalysointina, and the Director of the laboratory's responsibility or the change of the qualified person shall, without delay, notify the safety and development of the pharmaceutical sector.

section 4 (22.10.2009/803) know that the operative part of the responsibility of the Director of the pharmaceutical wholesale trade shall, without delay, notify the safety and development of the pharmaceutical sector.

section 5 (19 December 2002/1184) the list of medicinal products the sale of the pharmaceutical factories should be considered, which will have to cope with the number of the buyer, as well as its medicinal products sold and sales date.

section 5 (a) (19 December 2002/1184) (5) (a) section has been repealed A 19 December 2002/1184.

section 6 of the importation of medicinal products (22.10.2009/803) is set out in article 17 of the law of medicine importers to keep in a register, indicating the number of imported medicines, as well as the importing country, and maahantuontipäivämäärä.
The medicine's importer of a substance referred to in paragraph 4, in addition to the medical notification without delay is the security and the development of the pharmaceutical sector imported pharmaceutical substances. Notification must include information on the quantity and quality of the substance in the sector for the pharmaceutical, as well as the intended use.

section 6 (a) (c-372/97/312), importers of medicinal products shall ensure that the medicinal products are imported from countries outside the European economic area is made by legitimate pharmaceutical companies at least comply with the provisions of the European Union, in accordance with the good manufacturing practice of medicinal products.
In addition, the myyntiluvallisten of pharmaceutical products, the importer shall ensure that the countries outside the European economic area, each consignment of imported pharmaceutical products has been carried out in Finland or in another country of the European economic area, in accordance with the requirements of the marketing authorisation for the medicinal product quality assurance inspection. The inspection will be in Finland, the complete safety of the pharmaceutical sector and by a laboratory approved by the Centre. (22.10.2009/803)
The audit referred to in subparagraph (1) above may be waived, provided that the European Community and the country, have agreed the necessary arrangements in order to ensure that the manufacturer of the medicinal product in accordance with the acts of the European Community to comply with at least the good manufacturing practice of medicinal products and the inspection of the quality of the actions are performed in the country.
Suorituttamisesta of the audit on the other is, mutatis mutandis, to article 10 of the law in force, what medicine provides.

in respect of the wholesale distribution of medicinal products medicinal products article 7 in respect of the acquisition, sale, importation and storage of the medicinal product on the basis of article 36 of the law should be held to be of all pharmaceutical products, the trade name, as well as the amount, the name and address of the supplier or the buyer, as well as the date of the purchase or sale. (19 December 2002/1184)
The list referred to in subparagraph (1), the sale must be able to specify the medicinal products referred to in article 34 of the law of medicine buyers. (temporary number/1490)
There are two times a year in the pharmaceutical wholesale trade report it to security and development in the pharmaceutical sector to the Centre from the sale or other disposal of medicinal drugs Act section 34 for the buyers. (22.10.2009/803), section 7 (a) (19 December 2002/1184), section 7 (a) is repealed by A 19 December 2002/1184.

section 8 (30.12.1993/1604) Pharmaceutical Factory and the pharmaceutical wholesale trade can be used to sell or otherwise dispose of the 1961 Single Convention on Narcotic Drugs (Treaty Series 44/65) I, II and IV of the Convention on psychotropic substances (Treaty Series 60/76) lists the drugs referred to in (I) and (II) the hospital pharmacies, dispensaries of medical centres, military and vets only on the basis of a separate written order.

The marketing authorisation of the medicinal and special permit (19 December 2002/1184), section 9 (22.10.2009/803), the Centre for the development of security and in the pharmaceutical sector is the proprietary medicinal product in the context of the granting of the marketing authorisation of the medicinal product shall be decided whether to sell or otherwise dispose of for consumption only on the basis of a medical prescription.
Centre for the development of the pharmaceutical sector in the security and of the decision referred to in paragraph 1 may be amended in the preparation of new medicinal products, on the basis of the classification of the active provision of information.

section 10 (19 December 2002/1184), section 10 is repealed A 19 December 2002/1184.

10 (a) in the section (22.10.2009/803) the authorisations referred to in Chapter 4 of the law and applications for registrations, you have to deal with the safety of the pharmaceutical sector-and Development Center within the following periods: 1) marketing authorisation and registration of the 210 days;
2) parallel imports 130 days; and 3) special permit for a period of 30 days.

If the change of the marketing authorisation Commission Regulation (EC) No 1782/2003 shall apply to the 1084/2003 issued by the competent authority of the Member State of the medicinal products for human use and veterinary medicinal products referred to in the marketing authorisation application for the examination of variations to the terms, there will be a change in the time limits laid down in the said regulation, in accordance with the process. In addition, these medicinal products, package leaflet and labelling change must be treated within 90 days if the change does not affect the approved summary of product characteristics. The other change in the marketing authorisation of medicinal products and the registration of the application, the processing time may be longer than the established above.
The reform of the marketing authorisation and registration will be processed within 180 days.
First, the time limits referred to in articles 1 to 3 shall be calculated from the time the appropriate application with the report is submitted to the Centre for security and development in the pharmaceutical sector. If as a result of the application of the Central ask the applicant for further study, not the time it takes for the adoption of the report include the processing time.
If your question is of another competent authority of the Member State in accordance with the provisions of the European Community, the marketing authorisation for the recognition of the decision, made by the pharmaceutical safety and must be approved by the Centre for the development of an assessment report drawn up by the reference Member State, the summary of product characteristics, labelling and package leaflet within 90 days of the date of the arrival of the acceptance of the application and shall inform the reference Member State, or will be within the same period, to take measures to bring the provisions of the European Community, as required by the European Medicines Agency. As stated in this paragraph of the reference Member State, the procedure established pursuant to achieving consensus on the safety of the pharmaceutical sector and the Centre for the development of the marketing authorisation shall be issued within 30 days of the date of notification.
The granting of a marketing authorisation, the marketing authorisation for the medicinal product, as well as changing the amount of the withdrawal or a ban on the transfer of the consumption of the medicinal product, in which an institution of the European Union in accordance with the provisions of the European Community has made a decision, must be resolved within 30 days of the notification of the decision.

section 10 (b) (19 December 2002/1184) in the pharmaceutical sector for the development of security and can grant the medicine referred to in article 21 (f) of the laws of the special permit, if an individual patient or for an individual animal or group of animals in the treatment is not available in the other treatment or treatment has not achieved the desired result. The special permit may also be granted in cases where the patient in order to prevent disease in the general population for the performance of the group or is not available for the granting of the specific authorisation of the medicinal product and the myyntiluvallista is especially weighty reasons. Potilasryhmäkohtaista, by issuing a special permit to the security and development of the pharmaceutical sector will need to take account of the opinion of the European Medicines Agency's Committee for medicinal products for human use of the possible opinion on the matter. (22.10.2009/803)
Upon delivery to the donor's express approval of the proprietary medicinal product will help to ensure that the user receives sufficient information on the safe use of the product in the right and, as well as storage and other documentation.

Article 10 (c) (19 December 2002/1184) special permit is requested in writing to the security and development of the pharmaceutical sector. Special permission may be granted to the pharmacy, pharmacy, hospital pharmacy, the page-pharmacy, medicine wholesale, medicine, health and well-being of the body or the factory Elintarviketurvallisuusvirastolle. Erityislupahakemuksen should contain: (22.10.2009/803) 1) a statement of the applicant;
2 the name of the medicinal product, strength), the pharmaceutical form, the amount of active substance of the medicinal product, the manufacturer, the importer, the pharmaceutical wholesale trade and consumption from the donor;
3) the patient's personal information if the product is not used in the hospital, health centre or in the private health care facilities in the context of the examination of the patient or the management of the productive unit;
4 report by the prescriber as well as of the specific medicinal product) sairaanhoidollisista of the reasons why the product is needed;
5) on an application for an individual patient and a copy of the prescription; and 6) the summary of product characteristics in a statement about the new erityislupavalmisteesta.
If a special permit is applied for in accordance with the veterinary report under paragraph 1, shall be in lieu of the information referred to in paragraph 3, 4 and 5 of the statement to the species or species for which the product is being sought to be used, as well as by the veterinarian for veterinary reasons, on the basis of which the product is required.

Article 10 (d) (19 December 2002/1184), containing the same active substance but with a different pharmaceutical form or to vahvuisille preparations, must apply for a separate erityisluvat. One of the erityislupahakemuksella veterinary medicinal products may, however, apply for a number of different types of medicinal drugs or products containing the content.

Article 10 (e) (19 December 2002/1184) special permit shall be issued for a period not exceeding one year. The special permit is valid for one year from the notification of the decision.

Article 10 (f) (22.10.2009/803), the Centre for the development of safety in the pharmaceutical sector, and can also administer the preparation of an application for temporary permits, on the basis of which it may be released for consumption, even though it does not have a drug within the meaning of subparagraph (1) of section 21 of the marketing authorisation.

Pharmacy, the pharmacy, the pharmacy service point and the page the pharmacy network service (01/27/2011/69) section 11 (01/27/2011/69) When a pharmacy permit is a decision on the establishment of a new pharmacy made or have been made, the security and development of the pharmaceutical sector will declare the pharmacy permit to be picked up by the relevant notice in the official journal of the. The public notice must be given to the pharmacy location information. The pharmacy licence must be applied for within 30 days of the date of publication of the alert.
An applicant for authorisation of biocidal products shall be accompanied by the statement of the pharmacy, adding to the medicines Act 43 of the conditions of the granting of the authorization referred to in the pharmacy, with the exception of the kind the applicant's capacity to act, the authority is able to obtain population information system and the population register Centre's certificate services (661/2009).

section 12 (01/27/2011/69) section 12 is repealed A 01/27/2011/69.

section 13 (01/27/2011/69) the Apothecary will be announcing to the security and development of the pharmaceutical sector in advance of the date on which he will take to a pharmacy or to keep the page from the pharmacy.

section 14 (19 December 2002/1184) section 14 is repealed A 19 December 2002/1184.

section 15 (22.10.2009/803) the pharmacy shall be: 1) to the customer in a space that is suitable for the medicine referred to in article 57 of the law, the adoption of the guidelines on the use of medicinal products meet the requirements of the provisions concerning professional secrecy;
adequate and appropriate storage facilities);
3) required for the manufacture of medicinal products and for quality assurance in a separate room; as well as 4) pharmacy, as required by the scale of sufficient change to the workspace.
Before the new pharmacy apartment opens to the public, or the premises referred to in paragraph 1 shall be made in a pharmacy of a material change, comes from the apothecary shall inform the pharmaceutical security and the development of new facilities and changes.

section 16 (19 December 2002/1184) section 16 is repealed A 19 December 2002/1184.

section 17 (01/27/2011/69) section 17 is repealed A 01/27/2011/69.

section 18 (19 December 2002/1184), section 18, is repealed A 19 December 2002/1184.

section 19 of the Pharmacy of the movement shifted to the other pharmacy is kept free of charge, provided for in the documents to be handed over to the new pharmacy shop operator.

under section 20 (19 December 2002/1184), Apothecary, which keeps the page from the pharmacy, shall lay down the page to the pharmacy manager. Page 52 of the laws of the pharmacy shall, on the basis of the pharmaceutical section to be a licensed pharmacist or the pharmacist. The pharmacy of the University of Helsinki page pharmacy manager must, however, be in order. Page hoitajasta a pharmacist shall be notified to the security and development of the pharmaceutical sector. (22.10.2009/803)
Apothecary or his or her designee of a licensed pharmacist shall be subject to the Pharmacy and the pharmacy the pharmacy service point page at least once a year. The inspection shall be kept by the vendor to sign the Protocol of the inspection. A copy of the Protocol on inspection shall be submitted to the Pharmacy and the pharmacy service point Manager page. (01/27/2011/69)
Page, in addition to what the above pharmacies shall apply to this section is provided for in this regulation, articles 14, 15, 17 and to the provisions of article 19.

section 20 (a) (19 December 2002/1184), 20 (a) in the section has been repealed A 19 December 2002/1184.

section 21 (01/27/2011/69) when applying for the security and development of the pharmaceutical sector in the Centre of the pharmaceutical law, the authorization referred to in article 52 (a) the pharmacy service in order to keep the application shall be accompanied by a statement, is the point: 1) to the applicant;
2) service point location in the sparsely-populated area or in the village in the Centre of town and country pharmacy or limited to the municipality;
3.) the fact that there are no prerequisites for the preservation of the pharmacy in the page;
4) service point from;
the State earmarked 5) service point;
6) service point of the planned aukioloajasta;
7) service point of the planned drug selection;
8), whether the service desk to deliver prescription drugs and how the supply of prescription-only medicines;
section 52 of the laws of the (a) 9): under medical advice on the plan;
the planned management of the service point from 10);
the establishment of specific reasons, point 11), when the pharmacy service point will be set up to ensure access to medicines for pharmaceutical law within the meaning of article 52 (a).

21 (a) section (01/27/2011/69)


Apothecary shall inform the Centre for security and development in the pharmaceutical sector, without delay, the pharmacy service point of operation and a substantial change in the operation of the.

Article 21 (b) (01/27/2011/69) the Apothecary shall ensure through appropriate medicinal products supplied to the Web service, the pharmacy's storage and transport conditions.
Pharmacy may charge no more than the relevant packaging and transport to the real additional costs borne by.

section 21 c (01/27/2011/69), the pharmacy's online service you will be able to get the medicine referred to in article 57 of the laws of the medical advice before the payment of the order through the Web service task or other.
Where a medicinal product referred to in article 57 of the laws of the medicine, thanks to the advice shows that you do not have to pay for their medicine, the payment reset, if the product is not sent to the client.

Hospital pharmacies, medical centers and military pharmacies (19 December 2002/1184) (19 December 2002/1184) when applying for a medical article 61 of the laws of the authorization referred to in the hospital pharmacy or medicine-the establishment of the Centre, is the application be accompanied by a statement: 1 the extent of its activities) 2) and the amount of the medicine supply sairaansijojen in the hospital pharmacy or Medicine Center;
3) hospital-pharmacy or medicine the Centre's premises and equipment;
4 the scope of the manufacture of medicinal products as well as) the estimated application of pharmaceutical forms;
in respect of the distribution; 5) as well as 6) in the hospital pharmacy or medicine hoitajasta and the rest of the staff of the Centre.
The hospital pharmacy or medicine, including a substantial change in the operation of the Centre, the hospital pharmacy and medicine the nurse responsible for the change of the Centre is to inform the Centre for security and development in the pharmaceutical sector. The hospital pharmacy and medicine center of medicine referred to in article 62 of the law after the authorisation has been granted, as well as the suspension and termination of the operation shall be notified immediately to the security and development of the pharmaceutical sector. (22.10.2009/803) section 23 (19 December 2002/1184), article 62 of the law of medicine when applying for the authorization referred to in the provision of medicines in the hospital pharmacy or medical center, is the application be accompanied by a statement of the way in the provision of medicinal products and the effects of the region's pharmacy services.

section 24 (22.10.2009/803) Medicine referred to in article 67 of the law to the military to set up a pharmacy is required for security and development in the pharmaceutical sector. The time of the application for authorization shall be, mutatis mutandis, the information provided for in article 22.

The marketing of the medicinal product (19 December 2002/1184), section 25 (19 December 2002/1184) marketing of medicinal products shall mean all information, orders, procurement, or incentive measures with a view to the supply of the prescription of medicines, or promotion of the use of the purchase. This is, inter alia, the populations from the advertising, to persons qualified to prescribe or supply medicinal products, advertising and sales promotion as well as medical action. Marketing is also the sharing of samples of medicinal products.
The medicine is intended by the law and this regulation, the marketing is not: 1) labelling and package leaflets of medicinal products;
2) the exchange of letters that is done other than promotional.
3) press releases and other material relating to, for example, to pack changes or adverse-reaction warnings as part of General precautions for medicinal products;
price lists/4) directories and, if they do not contain any medicinal claims;
5) to human health or diseases, provided that they do not seek to deal with the Scriptures, even indirectly, to increase the sales of the medicinal product; and 6) approved by the authority, information on the vaccination campaigns for the population.

Article 25 (a) (19 December 2002/1184) in the marketing of the medicinal product, the information must be in all respects in the context of the granting of the marketing authorisation in accordance with the approved summary of the product characteristics listed in the specific information with respect to the possible presence of later being, as amended. Marketing material must not contain outdated information and shall not leave to divulge a crucial point, the lack of which can give a false impression of the drug, the composition of the medicinal product, the importance of the quality of the source, or lääkkeellisestä.
Marketing does not refer to the clinical trials so that a reference to the final conclusions of the study, issues an incorrect image of the extent or significance.
Homeopathic preparations may not be covered by the registration in marketing to inform therapeutic uses. (on 10 November 2005/868), section 25 (b) (19 December 2002/1184) of the population in the marketing of your ad if you are a clear indication that this is a medicine advertisement. The ad must be for the correct and safe use of the medicinal product, the information necessary for the purposes of drug safety, such as the relevant precautions, interactions, and side effects.
Populations from the marketing must not contain material that: 1) gives the impression that the doctor or the doctor's recommended treatment is unnecessary;
2) suggests that the effects of the medicinal product are guaranteed or is not related to the side effects, or that the effects are as good or better than the rest of the treatment or medication;
3) suggests that the health of the subject can be enhanced by the use of the medicinal product, or that a person's health status can be changes, if the proprietary medicinal product, however, shall not be taken, with the exception of the first subparagraph of article 25, paragraph 6 of the findings of the vaccination campaigns;
4) has been applied exclusively or principally at children;
5) refers to scientists, health professionals or the recommendations of public figures;
6) suggests that the medicinal product is a foodstuff, cosmetic or other consumer equipment;
7) suggests that the power of the proprietary medicinal product or security is based on the fact that it is from the wild;
8) can lead to an incorrect diagnosis or self-medication in the treatment of the way in which a detailed incident report;
9) refers, in improper, pelottelevin or misleading terms, to claims of recovery;
10) contains inappropriate, pelottelevia or misleading pictorial representations of changes in the body caused by disease or injury, or of the impact of the medicinal product in the body or a part thereof; or 11) mentions that the medicinal product has been granted a marketing authorisation.

Article 25 (c) (19 December 2002/1184) as this regulation lays down, for the marketing of medicinal products, applies, mutatis mutandis, to the Pharmacy and pharmacy palvelemille to be delivered to the referred to in the marketing of medicinal products for patients. For an individual patient, pharmacy or prescription-only medicines to be manufactured of self-help (ex tempore preparations) marketing, however, is prohibited.
As a pharmacist-prepared medicinal products may be marketed only in respect of those purposes, which, on the basis of the State of scientific knowledge, according to the pharmaceutical composition is obviously affected.

section 25 d (19 December 2002/1184) in the marketing materials for veterinary medicinal products is in addition to the above, provided for in this Regulation shall inform the holder of the marketing authorisation for the product, the product approved target species and withdrawal periods provided for in the product.

Article 25 (e) (19 December 2002/1184) to persons qualified to prescribe or supply medicinal products, targeted marketing material must always include the following: 1) in accordance with the relevant information of the summary of product characteristics, which relate to the preparation of the recommendations, as well as to the efficacy of the uses and security;
2 the legal supply of the product;)
3 the terms of compensation, the average health insurance), the cost of treatment, if possible, as well as different package sizes, retail prices; and 4) the date on which the report has been prepared in accordance with or.
All of the data used in the marketing of the bulletin shall be in accordance with the approved summary of product characteristics, accurate, up-to-date, verifiable and sufficiently complete to enable the reader to form a conception of the therapeutic value of the medicinal product. Taken from medical journals or scientific studies, as well as tables, and other visual presentations must be faithfully reproduced and the source accurately.

25 f § (19 December 2002/1184) Sample Kit itsehoitolääkkeestä shall be made available only to persons qualified to prescribe or supply medicinal products. The recipe for the drug to prescribe the medicinal product sample kit shall be made available only to the person who is so entitled. If the delivery of marketing authorisation of a medicinal product is connected to a limiting condition, may be disclosed only to the imposition of such a medicinal product sample pack of person who is so entitled. Pharmaceutical product shall be made available, only one sample of each calender year, the imposition of a medicinal product or package delivery person who is so entitled.
Medicine sample may only be transmitted on the basis of a written request, signed and dated,. Medicine sample must be exactly the same as the smallest market in the Pack. The medicine with the sample shall submit to the summary of product characteristics.
A sample of the packaging of the products as well as traditional herbal products, homeopathic registered not only in pharmacies for sale, may be imposed on pharmaceutical factory and wholesale to dispose of these products to retailers. (on 10 November 2005/868)
Drug, or mainly, on the central nervous system into a substance classified as a substance or a preparation containing the substance on medical psykotrooppista should not disclose the sample package.

The marketing authorisation holder shall submit to the safety of the pharmaceutical sector and the development of an annual summary of information shared the medicine samples. A summary of the information to be given shall include details of the quantities of samples distributed during the year in medicine valmistekohtaisesti. (22.10.2009/803) 25 (g) section (19 December 2002/1184) Emergency kits should not be used in the marketing of proprietary medicinal products.

section 25 h (19 December 2002/1184) Medicine-the rapporteurs shall contain sufficient information to be able to give the markkinoimastaan the information is precise and as complete as possible of the pharmaceutical product. Medical is always forward or available to their customers, as well as the summary of product characteristics of the medicinal markkinoimansa the price of the medicinal product and replacement information.

section 25 i (22.10.2009/803), the holder of the marketing authorisation for the medicinal product shall be provided to the security and development of the pharmaceutical sector in its marketing of the material and the evidence at the request of the recipients, from the date of the first distribution the distribution of agricultural products, as well as other information and reports, which are necessary for the medicinal product of law 91, 91a, 91 (b) and the marketing of the medicinal products in accordance with article 92.

The control section 26 of the medicines Act in the context of the checks provided for in article 77 shall, in particular, to pay attention to: 1) that the medicinal product to be manufactured, quality assurance, responsible for the storage, distribution and sale of the drug law and the provisions of this regulation, as well as on the basis of the provisions adopted on the basis thereof is granted, and that the medicine works, drugs in clinical medicine research unit, manufacturing pharmaceutical wholesaler, pharmacy, a pharmacy, a pharmacy, a page in the hospital pharmacy or medical center is responsible for the conditions required for the purposes of granting the permit is required; (01/27/2011/69) 2) and pharmaceutical and other staff is sufficient;
3) that the drug law and the provisions of this regulation and the provisions adopted in the implementation of the list is kept, room facilities, tools and equipment are complied with; (24 March 1995/426) 4) that the medicines are prepared and maintained properly and that they are correct and comply with the provisions of the regulations, and; as well as (24 March 1995/426) 5) that the animal lääkitsemisestä Act (407/90) shall be prohibited or restricted on the basis of pharmaceutical substances are used in the manufacture of medicinal products, without breach of the law, or sold or otherwise disposed of to the said law. (24 March 1995/426)
In addition, the inspection shall pay attention to the fact that your pharmacist and other substances or products sold on the page from the pharmacy than in the case of medicinal products are complied with in respect of a substance or preparation, what is explicitly specified.

Article 27 of the check shall be the subject of a Protocol, which is a copy of the authority within 30 days of the matter to the Director of the pharmacy, subject to the responsibility of the hospital pharmacy or medicine the Center's Manager.
A copy of the Protocol, drawn up in the inspection shall be kept for inspection for a period of 10 years.
The inspection shall be considered as terminated, when the copy of the notification to the party concerned, clinical medicine and veterinary medicine studies (19 December 2002/1184) in accordance with § 28 (29 April 2004/312) section 28 is repealed A 29 April 2004/312.

Article 28 (a) (19 December 2002/1184) in order to obtain the role of marketing authorisation for a veterinary medicinal product in a clinical research study for veterinary medicinal products, the sponsor, or its representative, prior notification to the security and development in the pharmaceutical sector to the Agency at least 60 days prior to the scheduled commencement of the investigation. (22.10.2009/803)
If the veterinary medicinal product in article 21 of the law on medicinal products the marketing authorisation referred to in paragraph 1, in accordance with the clinical trial, prior notification to the animal research has to be done only when: 1) research on new topics, which are not included in the continuance of the marketing authorisation;
2) research should be made using the substance or a placebo;
3) is used in the target animal species or categories of animals to which the treatment of, or for use in, followed by the drug has not been approved;
4) study using other than an approved pharmaceutical forms, strengths of the medicinal product, or;
5) the investigation is substantially in the past approved doses, routes or treatment periods; or in the case of a clinical multicenter study 6).

Miscellaneous provisions article 29 (22.10.2009/803), the Centre for the development of safety in the pharmaceutical sector and the number of those criteria, the extent to which Sweden, Denmark, Norway or Iceland, a licensed physician, in countries other than those of the single Convention on Narcotic Drugs 1961, written, lists (I), (II) and (IV), as well as of the Convention on psychotropic substances listed in (I) and (II) on the basis of the provisions of the pharmaceutical drugs can be delivered to the medicines in Finland.

section 30 (19 December 2002/1184) in a hospital outpatient clinic or health center doctor's Office did little to justify the treatment free of charge to the patient may be disclosed to the immediate necessary drugs until he may be, taking into account the local conditions, could reasonably be expected to receive them at the pharmacy. The medicinal product shall be made available, the doctor, which must ensure that the patient receives the appropriate instructions for the purpose of ensuring the correct and safe use of the medicinal product. The originators of the drug must be ready to use.

section 31 (19 December 2002/1184) section 31 is repealed A 19 December 2002/1184.

section 32 of this Regulation shall enter into force on 1 January 1988. vvvk. 193/86, THEY bet 259/86, suvk. Mrs. 259/86, vvvk. bet 2/87 acts entry into force and application in time: 15.2.1991/316: This Regulation shall enter into force on 1 March 1991.

8.3.1993/249: This Regulation shall enter into force on 15 March 1993.

temporary number/1490: This Regulation shall enter into force on 1 January 1994.
A person who at the date of entry into force of this regulation, acting under the responsibility of the Director of the pharmaceutical factory, but which does not comply with article 3 of this regulation, the requirements laid down in paragraph 1, without prejudice to the provisions on liability may be under the influence of a leader.
Before the entry into force of this Regulation may be to take the measures needed to implement it.
Annex II to the EEA Agreement, Council directives (65/65/EEC, 75/318/EEC and 75/319/EEC, 87/21/EEC, 81/851/EEC, 81/852/EEC, 85/432/EEC and Directive 91/356/EEC) 30.12.1993/1604: This Regulation shall enter into force on 1 January 1994.

24 March 1995/426: This Regulation shall enter into force on 1 April 1995.
Before the entry into force of this Regulation may be to take the measures needed to implement it.
Council Directive 93/39/EEC; OJ No l L 214, 24.8.1993, p. 22, 93/40/EEC; OJ No l L 214, 24.8.1993, p. 31, 85/358/EEC; No 1782/2003 L 191, 23.7.1985, p. 46 22.11.1996/904: This Regulation shall enter into force on 1 January 1997.

19 December 2002/1184: This Regulation shall enter into force on 1 January 2003.
At the time of entry into force of this regulation, in accordance with the provisions in force of the hospital pharmacy to change the behavior of the pharmaceutical law referred to in subparagraph (1) of article 61-their languages through their hospital hospital-apteekiksi, it is considered a new hospital-pharmacy. Such hospital district hospital-pharmacy is to apply for medicine law in accordance with the third paragraph of article 61 the authorisation as set out in this regulation.
Before the entry into force of the regulation may be to take the necessary steps for its implementation.
European Parliament and Council Directive 2001/83/EC (32001L0083); OJ No l L 311, 28.11.2002, p. 67 29 April 2004/312: This Regulation shall enter into force on 1 May 2004.
Of the European Parliament and of the Council Directive 2001/20/EC (32001L0020); OJ No l L 121, 1.5.2001, p. 34-44 of the European Parliament and of the Council Directive 2001/83/EC (32001L0083); OJ No l L 311, 28.11.2001, p. 67-128 the Commission Directive 2003/94/EC (32003L0094); OJ No l L 262, 14.10.2003, born on 10 November 2006, 22-26/868: This Regulation shall enter into force on 14 November 2005. Medical products agency must be applied in accordance with article 10 of this regulation, the time limits for all licensing, registration, modification, and renewal applications that have been made on 30 October 2005 or after. If the application for marketing authorisation or registration reform is made on or before 30 April 2006, the institution, however, like to refer to the application of article 10 (a) by way of derogation from paragraph 3, within a period of 90 days.
Before the entry into force of this regulation, the institution of medicine delivered to the rinnakkaistuontimyyntilupahakemukset have to deal with the 130 days of the entry into force of this regulation.
Of the European Parliament and of the Council Directive 2001/82/EC (32001L0082); OJ No l L 311, 6.11.2001, p. 1, the European Parliament and Council Directive 2001/83/EC (32001L0083); OJ No l L 311, 6.11.2001, p. 67, the European Parliament and of the Council Directive 2004/24/EC (32004L0024); OJ No l L 136, 31 March 2004, p. 85, of the European Parliament and of the Council Directive 2004/27/EC (32004L0027); OJ No l L 136, 31 March 2004, p. 34, the European Parliament and of the Council Directive 2004/28/EC (32004L0028); OJ No l L 136, 31 March 2004, p. 58, Commission Regulation (EC) No 1782/2003 1084/2003 (32003R1084); OJ No l L 159, 27.6.2003, s 1 22.10.2009/803: This Regulation shall enter into force on 1 November 2009.
Before the entry into force of the regulation may be to take the measures needed to implement the regulation.

01/27/2011/69: This Regulation shall enter into force on 1 February 2011.
The entry into force of this regulation pending the entry into force of the regulation, the authorisation applications will be processed in accordance with the provisions in force.

Before the entry into force of this Regulation shall continue to apply to licences issued in the medicine cabinet, and shall be subject to the entry into force of this regulation, the provisions in force. Pharmacies, which is authorized to the medicine cabinet, may apply for the safety of the pharmaceutical sector-and Development Center in the medicine cabinet with the permission of the licence authorisations granted to the replacement of the pharmacy service point, if a pharmacy service point 52 of the laws of the medicinal products (a) the conditions provided for in article.
Before the entry into force of the regulation may be to take the measures needed to implement the regulation.