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The presentation of the Minister for Social Affairs and Health is provided for in the Pharmaceutical Law of 10 April 1987 (195/87) Pursuant to:
For the purpose of applying to the Pharmaceutical Safety and Development Centre (395/1987) § 8 Shall be accompanied by an application for the manufacture of medicinal products:
(1) the statutes or equivalent document for the applicant and the applicant, or, in the case of a foreign trader registered by a branch in Finland, the trade register of the branch;
(2) a description of medicinal products, medicinal products and pharmaceutical forms intended to be produced in the pharmaceutical company;
(3) a report on the estimated quantity of pharmaceutical production in the pharmaceutical company;
(4) a report on the location and premises of the pharmaceutical plant and the equipment used in production and quality control;
(5) a description of production quality assurance;
6) a report on the staff of the pharmaceutical plant; and
(7) a statement of the responsible director and the qualifying person referred to in Article 9 of the Medicinal Products Act.
This authorisation applies only to pharmaceutical forms or medicinal products specified in the authorisation granted by the Agency for the Safety and Development of the Medicinal Products. The manufacture of other pharmaceutical forms or substances requires a change in the authorisation granted. The application must be submitted separately from the pharmaceutical safety and development centre. The application for an amendment shall include, where appropriate, explanatory notes in accordance with paragraph 1. Where essential changes in production or quality control are otherwise made in the pharmaceutical company, a notification shall be made to the Centre for Security and Development in the Pharmaceutical Sector.
For the purpose of applying the authorisation referred to in Article 8 of the Pharmaceutical Act for the purpose of carrying out tasks related to the quality control of medicinal products referred to in Article 8 of the Pharmaceutical Act, the application shall be accompanied by the application of Article 8 (1) mutatis mutandis. Studies. The authorisation granted to the unit or laboratory performing the functions of quality control of medicinal products shall be limited to the analytical techniques specified in the authorisation granted by the Agency. In the case of applications for modification and modification of the authorisation, the provisions set out in paragraph 2 shall apply mutatis mutandis.
The unit responsible for carrying out the functions of quality control of medicinal products as a contract analysis unit and the accountable manager of the laboratory shall have an appropriate higher education qualification, adequate experience in quality control analysts, and If applicable, the validity required under Article 9 (2) and (3) of the Pharmaceutical Law. If the functions of the unit and the laboratory do not include the approval of batches of medicinal products, it does not have to be in the service of a qualified person within the meaning of Article 9 (2) and (3) of the Medicinal Products Code.
The authorisation referred to in Article 32 of the Medicinal Products Code for the purposes of applying to the pharmaceutical safety and development centre shall be accompanied by:
1) the order of business of the applicant or equivalent document, as well as the applicant, or, in the case of a foreign trader registered in Finland by a branch, a trade register of the branch;
(2) an assessment of the scale of the pharmaceutical wholesale distribution;
(3) a description of the location and premises of the pharmaceutical wholesale trade, as well as equipment and instruments;
(4) a report on the staff of the pharmaceutical wholesale trade;
5) a description of the arrangements for the transport of medicinal products;
6) a report on the treatment and quality control of medicinal products;
(7) a statement of the responsible Director referred to in Article 33 of the Pharmaceutical Code; and
(8) a statement of the contingency plan referred to in Article 7a of this Regulation.
In addition, the holder of a pharmaceutical wholesaler who wishes to engage in a pharmaceutical wholesale activity in Finland under Community law, who wishes to engage in a pharmaceutical wholesale activity in Finland, shall, in addition to the provisions of paragraph 1, attach to the application a description of the On the authorisation granted by a State belonging to the European Economic Area.
In the event of a substantial change in the operation of the pharmaceutical wholesaler, a notification shall be made to the Centre for Security and Development in the pharmaceutical sector.
The application for authorisation referred to in Articles 8, 15a or 32 shall be settled within 90 days of receipt of an application for authorisation to the Agency for Safety and Development in the pharmaceutical sector. (22/02/803)
The application for an amendment to the authorisation referred to in Article 1 (2) and (3) shall be settled within 30 days of receipt of the application. For a specific reason, which shall be notified to the applicant before the end of the abovementioned period, the time limit for processing the application may be extended by a maximum of 60 days.
The time allocated to the submission or explanation of the additional explanation shall not be read in the time of proceedings referred to in this Article.
Pharmaceutical plant, medicinal products for clinical trials, as well as a person fulfilling the responsibilities of the unit responsible for the quality control of medicinal products and of a person fulfilling the responsibility of the laboratory responsible for the quality control of medicinal products Must be notified immediately to the Agency for Safety and Development in the pharmaceutical sector.
The exchange of responsibilities of the pharmaceutical wholesaler shall be notified without delay to the Centre for Security and Development in the pharmaceutical sector.
The pharmaceutical company shall keep a list of the sale of medicinal products, which shall be sold as a medicinal product and the quantity, the buyer and the date of sale.
Paragraph 5a has been repealed by A 19.12.2002/1184 .
Importers referred to in Article 17 of the Pharmaceutical Code shall be kept on the list of imported medicinal products, indicating the imported medicinal product and the quantity, the country of importation, the supplier and the date of import.
In addition, the importer of a medicinal product as referred to in Article 17 (4) of the Medicinal Products Act shall, without delay, report to the pharmaceutical safety and development centre on imported medicinal products. The notification shall include information on the quantity and quality of the imported medicinal product and the intended use.
Importers of medicinal products must be assured that medicinal products imported from countries outside the European Economic Area have been manufactured by legitimate pharmaceutical manufacturers, in accordance with at least the medicinal products prescribed by the European Union Production methods.
In addition, the importer of authorised medicinal products shall ensure that any consignment of medicinal products imported from countries outside the European Economic Area has been carried out in Finland or in any other eea member To verify the quality of the medicinal product in accordance with the requirements of the marketing authorisation. The inspection will be carried out in a laboratory approved by the Medical and Development Centre in Finland. (22/02/803)
The inspection referred to in paragraph 1 may be waived provided that the European Community and the country from which the imports are made have agreed on the necessary arrangements to ensure that the manufacturer of the medicinal product complies with at least the European Good manufacturing practices for medicinal products in accordance with Community legislation and that quality control measures are carried out in the country from which imports are carried out.
The other provisions of Article 10 of the Pharmaceutical Code shall apply mutatis mutandis to the performance of the audit.
On the basis of Article 36 of the Law on the acquisition, sale, import and storage of medicinal products in the pharmaceutical wholesale market, the list to be held on the basis of Article 36 of the Pharmaceutical Code must include the trade name and the name and address of the donor or purchaser; and The date of acquisition or sale. (19.12.2002/1184)
The list of sales referred to in paragraph 1 shall be able to specify the sale of medicinal products to the buyers referred to in Article 34 of the Pharmaceutical Code. (22.12.1993/1490)
Wholesale trade shall be notified twice a year to the Pharmaceutical Safety and Development Centre for the sale of medicinal products or other supplies to buyers referred to in Article 34 (2) of the Pharmaceutical Code. (22/02/803)
Paragraph 7a has been repealed by A 19.12.2002/1184 .
The pharmaceutical company and the pharmaceutical wholesale trade may be sold or otherwise extradited to the 1961 Single Convention on Narcotic Drugs (SopS 43/65) on lists I, II and IV and of the Convention on Psychotropic Substances (SopS 60/76) Drugs for hospitals, medical centres, military pharmacies and veterinarians only on the basis of a separate written order.
In the context of the marketing authorisation of the medicinal product, the Agency shall decide whether to sell or otherwise release the medicinal product only on the basis of a prescription.
The pharmaceutical safety and development centre may amend the decision referred to in paragraph 1 on the basis of the new information on the classification of the medicinal product, which affects the classification of the medicinal product.
Paragraph 10 has been repealed by A 19.12.2002/1184 .
Applications for authorisations and registrations referred to in Chapter 4 of the Medicines Act shall be processed within the Pharmacovigilance and Development Centre within the following time-limits:
(1) marketing authorisation and registration 210 days;
2) a marketing authorisation for parallel imports 130 days; and
3) special permit for 30 days.
Where the modification of the marketing authorisation is applicable to Commission Regulation (EC) No 1084/2003, amendments to the terms of the terms of the authorisation for the placing on the market of medicinal products for human and veterinary use by the competent authority of the Member State Shall be examined in accordance with the time limits laid down in that Regulation. In addition, the change in the package leaflet and the labelling of these medicinal products should be treated within 90 days if the amendment does not affect the approved spc. The time for processing the marketing authorisation and registration of other medicinal products may be longer than the previous one.
The reform of the marketing authorisation and registration should be reviewed within 180 days.
The time-limits referred to in paragraphs 1 to 3 shall be calculated on the basis of the submission of an appropriate application, together with the necessary explanations, to the Agency for Security and Development. If the Centre requests an additional explanation from the applicant as a result of the application, no further examination shall be made at the time of processing.
In the case of the recognition of a marketing authorisation decision taken by the competent authority of another State in accordance with European Community legislation, the Agency shall approve the assessment report prepared by the Member State of reference, The Summary of Product Characteristics, labelling and package leaflet within 90 days of receipt of the application and inform the Member State of approval of the application, or, within the same period, take action to bring it into line with the , the European Medicines Agency Referred to. Following the notification by the reference Member State of the agreement on the procedure found in this paragraph, the Agency shall issue a marketing authorisation within 30 days of the notification.
The issue of the granting of a marketing authorisation, the modification of the medicinal product and the withdrawal of the marketing authorisation granted or a prohibition on the use of the medicinal product in which a decision has been taken by the European Union institution in accordance with European Community legislation, Shall be resolved within 30 days of the date of the decision.
The Agency for the Safety and Development of the Pharmaceutical Centre may grant a special authorisation as referred to in Article 21f of the Medical Code, if no other patient, or any other animal or group of animals, is available for any other treatment or treatment Achieve the desired result. A special permit may also be granted in cases where there is no marketing authorisation for the treatment of a patient group or population or for the prevention of disease, and there are particularly serious reasons for granting a special authorisation. When granting a specific authorisation for a patient group, the Agency shall take into account the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency. (22/02/803)
In the case of a special authorisation, the donor should contribute to ensuring that the user receives adequate information on the correct and safe use of the product, as well as for storage and other instructions.
Special authorisation is requested in writing from the Medical and Development Centre. A special permit may be issued for pharmacies, secondary pharmacies, military pharmacies, pharmacy, pharmaceutical wholesalers, pharmaceutical companies, health and welfare institutions or Food Safety Agency. The application for a special permit shall include: (22/02/803)
(1) a description of the applicant;
(2) a description of the name, strength of the medicinal product, pharmaceutical form, the active substance, the amount of the medicinal product, the manufacturer, the manufacturer, the importer, the pharmaceutical wholesale trade and the consumption of the donor;
(3) the patient's personal data unless the product is used in a hospital, health centre or a private healthcare service unit in the course of the patient's examination or treatment;
(4) a report by the prescriber on the specific medical grounds for which the product is required;
(5) for an application for a single patient, a copy of the prescription; and
(6) a summary of product characteristics or equivalent examination of a new special authorisation product.
Where a special permit is sought for veterinary purposes, the report in accordance with paragraph 1 shall, instead of the information mentioned in paragraphs 3 to 5, report on the species or species to which the product is sought and an explanation given by the veterinarian. Veterinary reasons on the basis of which the product is required.
For products containing the same active substance, separate special authorisations should be applied to the different formulations or formulations of the medicinal product. However, one application for a special permit for veterinary medicinal products may apply for special authorisations for the different quantities of medicinal products or preparations containing the medicinal product.
A special permit shall be issued for a period not exceeding one year. The special permit shall be valid for a one-year decision.
The Agency for Safety and Development in the Pharmaceutical Sector may also, without a different application, give a specific authorisation for a medicinal product which allows it to be released for consumption, even though it does not have a marketing authorisation within the meaning of Article 21 (1) of the Medical Code.
When the pharmacist has become open or the decision to set up a new pharmacy has been made, the pharmaceutical safety and development centre should declare the pharmacy licence to be submitted by an alert published in the Official Journal. The alert should provide information on the location of the pharmacy. The application shall be submitted within 30 days of the date of publication of the alert.
The application for a pharmacist must be accompanied by an explanation of the conditions for the authorisation of a pharmacist, as referred to in Article 43 of the Medical Law, with the exception of the applicant's report on the term of office of the applicant whose authority may be obtained from: On the Population Information System and the Law on the Certification Service of the Centre (12/2009) Basis.
Paragraph 12 has been repealed by A 27.1.2011/69 .
The pharmacist shall inform the pharmaceutical safety and development centre in advance of the date on which he will undertake the practice of pharmacies or to hold a secondary pharmacy.
Paragraph 14 has been repealed by A 19.12.2002/1184 .
The pharmacy must have:
(1) a customer space suitable for the adoption of instructions relating to the use of medicinal products as referred to in Article 57 of the Pharmaceutical Code and complies with the requirements of confidentiality rules;
(2) adequate and appropriate storage facilities;
(3) the separate space required for the manufacture and quality assurance of medicinal products; and
(4) adequate additional work space, as required by the scope of the pharmacy.
Before the new pharmacy apartment is opened to the public or the pharmacy is made subject to substantial changes in the premises referred to in paragraph 1, the pharmacist shall inform the Medical and Development Centre of the new premises and changes.
Article 16 has been repealed by A 19.12.2002/1184 .
Paragraph 17 has been repealed by A 27.1.2011/69 .
Paragraph 18 has been repealed by A 19.12.2002/1184 .
In the case of a transfer of pharmacies to another pharmacist, the documents to be retained shall be handed over to the new pharmacist.
The apothecary, which keeps a branch pharmacy, must prescribe a side pharmacy as a nurse. On the basis of Article 52 of the Pharmaceutical Act, the nurse shall be a licensed pharmacist or pharmacist. However, the pharmacist at the University of Helsinki will have to be a pharmacist. An alert shall be submitted to the Agency for the Safety and Development of the Medical Service. (22/02/803)
The pharmacist or the licensed pharmacist must check the pharmacy side pharmacy and the pharmacy at least once a year. The inspection shall be carried out in accordance with the Protocol signed by the supplier. A copy of the verification protocol shall be communicated to the operator of the side pharmacy and the pharmacist. (27 JANUARY 2011/69)
Furthermore, the provisions of Articles 14, 15, 17 and 19 of this Regulation shall apply to side pharmacies.
Article 20a has been repealed by A 19.12.2002/1184 .
For the purpose of applying the authorisation referred to in Article 52a of the Medicinal Products Agency for the Safety and Development Centre for the Pharmaceutical Safety and Development Centre, the application shall be accompanied by a statement:
(1) the applicant;
(2) the location of the service station in the haya-settlement area or the village centre in the location of the pharmacy in or adjacent to the municipality;
(3) the absence of conditions for the maintenance of a secondary pharmacy;
4) at the address;
(5) the space reserved for the service point;
(6) the planned opening hours of the service project;
(7) the planned pharmaceutical product design;
(8) whether or not a service point is to be provided for prescription-only medicines and the provision of prescription drugs;
(9) medical advice plan in accordance with Article 52a of the Pharmaceutical Code;
(10) the planned management of the service base;
(11) For specific reasons, the creation of a new service point when the pharmacy service is set up to secure access to medicines within the meaning of Article 52a of the Pharmaceutical Code.
The pharmacist shall inform the Centre for Security and Development of the Pharmaceutical Centre without delay of the initiation and cessation of activities of the pharmacy pharmacy and the essential changes to its activities.
The pharmacist shall ensure appropriate storage and transport conditions for medicinal products supplied through the network service.
The pharmacy may recover the actual additional costs incurred by the customer for a maximum of appropriate packaging and transport.
The customer must have access to the medical advice referred to in Article 57 of the Pharmaceutical Code prior to payment or other confirmation of an order to be issued through the online service.
If, as a result of the medical advice referred to in Article 57 of the Medicinal Products Act, it is clear that the customer does not need the medicine he has paid, the payment shall be returned if the medicinal product has not been sent to the customer.
For the purpose of applying Article 61 (3) of the Pharmaceutical Act for the establishment of a hospital pharmacy or a medicinal centre, the application shall be accompanied by a statement:
1) on the applicant
2) the extent of the activity and the number of nurses responsible for the medical care of the hospital pharmacy or the medical centre;
(3) the premises and equipment of the hospital pharmacy or the medical centre;
(4) the estimated scope of the manufacture of medicinal products and the formulations to be produced;
(5) the delivery of medicinal products; and
(6) nurses and other staff of the hospital or medical centre.
Relevant changes in the activities of the hospital pharmacy or the medical centre, including the exchange of the hospital pharmacy and the drug centre, shall be notified to the Agency for Safety and Development in the pharmaceutical sector. Following the granting of the authorisation referred to in Article 62 of the Medical Code and the Agency's activities, and the suspension and termination of the activities of the Medical Centre, the Agency shall be informed immediately of the suspension and cessation of activities. (22/02/803)
For the purpose of applying Article 62 of the Pharmaceutical Law for the provision of medicinal products for the supply of medicinal products from a hospital pharmacy or a medical centre, the application shall be accompanied by a statement of the manner in which the medicinal products are supplied and the effect of the authorisation on the pharmacy services in the area.
For the establishment of a military pharmacy as referred to in Section 67 of the Pharmaceutical Code, a permit is required for the Centre for Security and Development in the pharmaceutical sector. The licence application shall contain, where applicable, the information provided for in Article 22.
The marketing of medicinal products shall mean any provision of information, ordering or inducing orders aimed at promoting the prescription, delivery, purchase or use of medicinal products. This includes advertising to the population, advertising and promotion of persons entitled to prescribe or supply medicinal products, and the activities of the pharmaceutical rapporteurs. There is also a marketing of pharmaceutical samples.
The marketing authorisation referred to in this Regulation and this Regulation shall not:
(1) labelling and package leaflets;
2) an exchange of letters, other than for promotional purposes;
(3) information sheets and other relevant documentation concerning, for example, packaging changes or warnings on adverse reactions as part of general precautions for medicinal products;
(4) directories and price lists if they do not contain claims for medicinal products;
(5) articles on human health or diseases, if they are not even implicitly aimed at increasing the sale of a medicinal product; and
(6) informing the public about vaccination campaigns approved by the Authority.
The information to be provided for the marketing of the medicinal product shall be in full compliance with the specific data listed in the Summary of Product Characteristics approved in the context of the granting of the marketing authorisation, with any subsequent amendments that may be adopted. Marketing material shall not contain outdated information and shall not omit an essential element which may give an incorrect impression of the medicinal product, its composition, its origin, the medicinal product Of importance or quality.
The marketing shall not refer to clinical studies in such a way that the reference provides an incorrect view of the conclusion, scope or significance of the study.
For homeopathic products covered by the registration, therapeutic indications shall not be indicated for marketing purposes. (10.11.2005/868)
In the context of the marketing of the population, it must be made clear that this is a commercial advertisement. The advertisement shall contain the information necessary for the correct and safe use of the medicinal product, such as the intended uses and safety precautions, interactions and adverse reactions.
The marketing of the population shall not contain material which:
1) give the impression that the doctor's visit or the treatment recommended by the doctor is unnecessary;
2) suggests that the effects of the medicinal product are guaranteed or have no adverse effects or that the effects are equal to or better than any other treatment or medication;
(3) suggests that a person's health may be improved by the use of a medicinal product or that changes in the person's state of health may occur if the medicinal product is not taken, except in the case of the exception found in Article 25 (2) (6); Vaccination campaigns;
(4) is aimed solely or principally at children;
(5) refers to the recommendations of scientific researchers, health professionals or public figures;
(6) suggests that the medicinal product is a food, a cosmetic product or another consumer article;
(7) suggests that the efficacy or safety of the medicinal product is based on the fact that it originates from nature;
(8) may lead to self-treatment as a result of a detailed case report of an incorrect diagnosis or treatment;
(9) refers to allegations of improvement in terms of inappropriate, deterrent or misleading expression;
(10) contains unsuitable, intimidating or misleading portraits of changes in the body or the effect of the medicinal product on the body or part of the body; or
11) states that a marketing authorisation has been granted.
The provisions of this Regulation on the marketing of medicinal products shall apply mutatis mutandis to the marketing of medicinal products for the supply of medicinal products produced in pharmacies and in pharmacies. However, marketing of self-therapeutic or prescription medicines (ex tempore) in a pharmacy is prohibited.
Pharmaceutical medicinal products manufactured in the pharmacy may be marketed only for uses which are most likely to be affected according to scientific knowledge on the basis of their composition.
In addition, in the marketing material for veterinary medicinal products, the marketing authorisation holder, the target species approved for the preparation and the withdrawal periods for the product shall be indicated in the marketing material for veterinary medicinal products.
The marketing material for prescribing and dispensing of medicinal products shall always include:
(1) relevant information according to the summary of product characteristics relating to the uses and recommendations of the product, and to the efficacy and safety of the product;
(2) the legal transmission conditions of the medicinal product;
(3) health insurance conditions, average care costs, if possible, and retail prices of different pack sizes; and
4) the date on which the notice has been drawn up or renewed.
All data for marketing communications shall be consistent with the agreed product summary, accurate, up-to-date, verifiable and sufficiently complete to enable the reader to form the opinion of the medicinal product The therapeutic value. The quotes from medical journals or scientific studies, as well as the tables and other illustrations, shall be strictly repelled and their source accurately reported.
The self-help medicine of the sample container shall be disclosed only to persons entitled to prescribe and supply the medicinal product. In the case of a prescription, the sample container may be released only to the person entitled to prescribe the medicinal product. If a marketing authorisation is attached to the marketing authorisation, a sample container may be released only to the person entitled to prescribe such a medicinal product. Only one sample pack should be released in the calendar year for each person entitled to prescribe or supply the medicinal product.
The sample shall be provided only on the basis of a written, signed and dated request. The sample must be exactly the same as the smallest packaging. A summary of product characteristics shall be provided with the medicinal product.
For homeopathic products registered in samples, and traditional herbal medicinal products which are not intended for sale only for pharmacies, the pharmaceutical company and the wholesalers may be released to the retailers of these products. (10.11.2005/868)
The substance or a medicinal product containing a psychotropic substance which contains a substance or a psychotropic substance which is primarily active in the central nervous system must not be presented as a sample pack.
The Marketing Authorisation Holder (mah) shall submit yearly summaries of the pharmaceutical samples to the Pharmacovigilance and Development Centre. The summary information shall include information on the quantities of pharmaceutical samples distributed during the year by product. (22/02/803)
The marketing of medicinal products should not be used in the marketing of medicinal products.
The pharmaceutical rapporteurs shall have sufficient information to provide accurate and as complete information as possible on the medicinal product marketed. The pharmaceutical rapporteurs must always provide or keep available to their customers the summary of product characteristics of the medicinal product they market and the information on the price and reimbursement of the medicinal product.
The marketing authorisation holder of the medicinal product shall submit to the Agency, at its request, marketing material and a report on the recipients, manner of distribution and the date of the first distribution, as well as Other information and explanations necessary for the supervision of the marketing of medicinal products in accordance with Articles 91, 91a, 91a and 92.
In the context of the checks referred to in Article 77 of the Medicinal Products Act, particular attention shall be paid to:
1) that the manufacture, quality assurance, storage, distribution and sale of medicinal products comply with the provisions of the Pharmaceutical Code and the provisions of this Regulation, as well as the provisions of this Regulation, and that a medicinal plant, medicinal products for clinical use The pharmaceutical company, the pharmaceutical wholesaler, the pharmacy, the pharmacy, the pharmacy, the pharmacy, the pharmacy, the pharmacy or the medical centre is responsible for the requirements for the granting of the authorisation; (27 JANUARY 2011/69)
(2) that there is sufficient pharmaceutical and other staff;
(3) compliance with the provisions of the Pharmaceutical Act and this Regulation and the provisions adopted pursuant thereto on keeping the list, room premises, instruments and equipment; (24.03.1995/42)
(4) that the medicinal products are properly prepared and preserved and comply with the provisions and regulations that are of sound quality; and (24.03.1995/42)
(5) and the Law on the Veterinary (402/90) Medicinal products which are prohibited or restricted are not used in contravention of the law in the manufacture of medicinal products, or sold or otherwise disposed of for purposes contrary to the law. (24.03.1995/42)
In addition, the examination shall pay attention to the fact that the other substances or preparations sold from the pharmacy and the side pharmacy, other than the medicinal products, are complied with, which is specifically provided for or prescribed for the substance or preparation.
A protocol shall be drawn up in respect of which a copy shall be submitted within 30 days of the responsibility of the responsible Director, the pharmacist, the nurse responsible for the hospital or the medical centre.
For a period of 10 years from the inspection, the copy of the protocol drawn up shall be maintained.
The inspection shall be deemed to have ended when a copy of the inspection protocol has been served on the party concerned
Paragraph 28 has been repealed by A 29.4.2004 .
A clinical veterinary study to obtain a marketing authorisation for a veterinary medicinal product is a prior notification by the applicant or its representative to the medical safety and development centre at least 60 days prior to the study. Planned commencement. (22/02/803)
If a veterinary medicinal product has a marketing authorisation as referred to in Article 21 of the Medicinal Products Act, a prior notification of a clinical veterinary study in accordance with paragraph 1 shall be carried out only where:
(1) the investigation concerns new indications that are not included in the current marketing authorisation;
(2) research is carried out using a reference substance or placebo;
(3) the use of target animal species or groups of animals for which the medicinal product authorised or authorised for use has not been authorised;
(4) study uses other than previously authorised pharmaceutical forms, combinations of medicines or strengths;
(5) the investigation substantially changes the previously accepted doses, routes of administration or treatment periods; or
6. It is a multicentre clinical trial.
The safety and development centre of the pharmaceutical sector shall determine the extent to which, in the countries of Sweden, Denmark, Norway or Iceland, the non-1961 Single Convention on Narcotic Drugs (II), II and IV And the pharmaceutical provisions on narcotic drugs listed in lists I and II of the Convention on Psychotropic Substances may be supplied in Finland.
In the case of a patient who has received a medical emergency at a hospital or a medical centre, the medicinal products may be released free of charge for immediate treatment until such time as he can reasonably be expected to Get them from the pharmacy. The medicine must be given by a treating physician to ensure that the patient receives appropriate instructions for the correct and safe use of the medicine. The dispensable medicine must be ready for use.
Paragraph 31 has been repealed by A 19.12.2002/1184 .
This Regulation shall enter into force on 1 January 1988.
HE 193/86, yyyy 259/86, family figure. 259/86, yyyy. 2/87This Regulation shall enter into force on 1 March 1991.
This Regulation shall enter into force on 15 March 1993.
This Regulation shall enter into force on 1 January 1994.
Without prejudice to the provisions of Article 3 (1) of this Regulation, a person who, at the time of entry into force of this Regulation, acts as a responsible manager but does not fulfil the requirements laid down in Article 3 (1) of this Regulation shall continue to act as a responsible manager.
Before the entry into force of this Regulation, 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)
This Regulation shall enter into force on 1 January 1994.
This Regulation shall enter into force on 1 April 1995.
Before the entry into force of this Regulation, measures may be taken to implement it.
Council Directive 93 /39/EEC; OJ L 214, 24.8.1993, p. 22, 93 /40/EEC; OJ L 214, 24.8.1993, p. 31, 85 /358/EEC; No L 191, 23.7.1985, p. 46
This Regulation shall enter into force on 1 January 1997.
This Regulation shall enter into force on 1 January 2003.
In accordance with the provisions in force at the time of entry into force of this Regulation, the modification of the activities of a hospital pharmacy authorised in accordance with the provisions of Article 61 (1) of the Pharmaceutical Act shall be considered as a hospital pharmacy for a new hospital. To establish. An application pursuant to Article 61 (3) of the Medical Code must be sought in accordance with Article 61 (3) of the Medical Service.
Before the entry into force of the regulation, measures may be taken to implement it.
Directive 2001 /83/EC of the European Parliament and of the Council (32001L0083); OJ L 311, 28.11.2002, p. 67
This Regulation shall enter into force on 1 May 2004.
Directive 2001 /20/EC of the European Parliament and of the Council (32001L0020); OJ L 121, 1.5.2001 Directive 2001 /83/EC of the European Parliament and of the Council (32001L0083); OJ L 311, 28.11.2001, p. Commission Directive 2003 /94/EC (32003L0094); OJ L 262, 14.10.2003, p. 22-26
This Regulation shall enter into force on 14 November 2005. The medicinal product shall apply the time-limits laid down in Article 10 of this Regulation for all applications for authorisation, registration, conversion and renewal which have been made on or after 30 October 2005. However, if the application for a renewal of a marketing authorisation or registration has been submitted on 30 April 2006 or before, the application shall, by way of derogation from the provisions of Article 10a (3), be processed within 90 days.
Applications for parallel import licences submitted before the entry into force of this Regulation shall be processed within 130 days following the entry into force of this Regulation.
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. Commission Regulation (EC) No 1084/2003 (32003R1084); OJ L 159, 27.6.2003, p. 1
This Regulation shall enter into force on 1 November 2009.
Before the entry into force of the regulation, measures may be taken to implement the Regulation.
This Regulation shall enter into force on 1 February 2011.
Applications for authorisation pending the entry into force of this Regulation shall be processed in accordance with the provisions in force at the date of entry into force of the Regulation.
Pharmaceutical licences issued before the entry into force of this Regulation shall remain in force and shall be subject to the provisions in force at the time of entry into force of this Regulation. The pharmacist, 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 the pharmacy is provided for in Article 52 (a) of the Pharmaceutical Code. The conditions are fulfilled.
Before the entry into force of the regulation, measures may be taken to implement the Regulation.
