Notice Of Distribution Of Medicinal Products

Original Language Title: Bekendtgørelse om distribution af lægemidler

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Overview (table of contents)



Chapter 1



Executive order area





Chapter 2



Definitions





Chapter 3



Permission for wholesale distribution





Chapter 4



Registration of dissemination of medicinal products





Chapter 5



Good distribution practice





Chapter 6



Good distribution practice for dissemination





Chapter 7



Inspection, disclosure of information, etc.



The full text of the Executive order on distribution of lægemidler1)

Pursuant to section 29, paragraph 3, section 39 (a), paragraph 1, section 39 (b), article 41 (c), section 41 d, section 43 (a), article 92, paragraph 3, and section 104 (3) of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 1258 by 18. December 2012, and under section 38 (2) of section 43 and section 72, paragraph 2, of the law on pharmacy company, see. lovbekendtgørelse nr. 855 of 4. August 2008, as amended by Act No. 1258 by 18. December 2012 shall be determined: Chapter 1 scope § 1 of the Executive order. This notice includes the wholesale distribution of medicinal products as well as retail sale of medicines from the pharmacy, including stock holding, see. However, paragraph 2.

(2). The Ordinance does not apply to: 1) retail sale of homeopathic medicines, anthroposophic medicines, herbal remedies, traditional herbal products, vitamin and mineral preparations and medical gases, and 2) retail sale of medicines from pharmacy OTC outlets or from retail dealers with permission to sell OTC medicines according to § 39, paragraph 1, of the law on medicinal products.

§ 2. The notice applies to companies and individuals who have received the National Board of Health's permission for the wholesale distribution of medicinal products in accordance with § 39, paragraph 1, of the law on medicinal products, for applicants for such permission, where this is expressly stated in the individual provisions, and for pharmacies, including hospital pharmacies.

(2). The notice shall also include, where this is expressly stated by the individual provisions, intermediaries of medicinal products which have been registered pursuant to section 41 (b), paragraph 1, of the law on medicinal products.

Chapter 2 Definitions section 3. For the purposes of this order: 1) good distribution practice (GDP) mean the part of quality assurance which ensures that medicines properties in good condition during distribution, and the defective medicines can be traced and withdrawn.

2) Distribution: any type of activity that consists in the wholesale or retail sale of medicines.

3) Wholesale Distributor: a company or person who carry out or have carried out wholesale distribution.

4) wholesale distribution: any type of activity which consists in to buy, sell, receive, hold or deliver drugs within the EU/EEA, or from exporting medicines to third countries, with the exception of distribution of medicinal products to users.

5) retailer: a company or a person who carries out the retail sale.

6) retail sale: any type of activity, which is to receive, hold, sell and supply medicinal products to the users.

7) supplier: a manufacturer, an importer or a wholesale dealer, who makes the delivery to the next link in the distribution chain.

8) Importer: anyone who has health's permission to import medicines under section 39, paragraph 1, of the law on medicinal products, as well as pharmacies, including hospital pharmacies, medicinal products coming.

9) Imports: Imports of medicinal products from a country outside the EU/EEA (third country).

10) Manufacturer: The company or individual who has health's permission to manufacture medicinal products pursuant to section 39, paragraph 1, of the law on drugs, and if the qualified person has made the final release of the batch, as well as pharmacies, including hospital pharmacies, making such a release.

11) quality assurance system: the system that ensures that the distributed medicines complies with the rules of this order, to the storage conditions are fulfilled at all times, including during transport, to contamination with or by other products be avoided that the medicines dispensed to the person concerned, and that they can be traced.

12) Control Certificate: Certificate signed by the qualified person at the manufacturer, with the person responsible for importation or at the contract Acceptor that the medicinal product, including intermediate products and active substances are manufactured in accordance with good manufacturing practice and meet the requirements, which form the basis of the marketing authorisation.

13) qualified person means a person who meets the minimum requirements for scientific and technical qualifications, laid down in article 49, paragraph 2-3 of Directive 2001/83/EC or article 53, paragraphs 2-3 of Directive 2001/82/EC and if appropriate, article 13, paragraph 2, of Directive 2001/20/EC.

14) Quality responsible person: A person designated by the company to ensure that the company complies with applicable rules of good distribution practice.

15) Receive control: ensuring that the drug's storage conditions have been complied with in transit, that the documentation required pursuant to this notice has been provided and that the delivered medicines corresponding to the quantity ordered.

16) Facilitator of medicinal products: a company or person making the dissemination of drugs.

17) Dissemination of medicinal products: all activities related to the purchase and sale of medicinal products, with the exception of wholesale distribution, which does not include physical handling, but consist of negotiating independently on behalf of another legal or natural person.

18) falsified medicinal product: any medicinal product with an incorrect description of: (a)) its identity, including its packaging and labelling, its name or its composition, with regard to any of the ingredients, including excipients, and the strength of these constituents, b) its origin, including its manufacture, its manufacturing country, its country of origin or the holder of the marketing authorisation for it, or c) its history, including records and documents related to the channels of distribution used.

Chapter 3 Authorization for wholesale distribution § 4. In order to obtain permission for the wholesale distribution of medicinal products in accordance with § 39, paragraph 1, of the law on medicinal products, the applicant must: 1) have an adequate number of staff, which complies with the requirements of §§ 15-16 and 2) have rooms and equipment that satisfies the requirements of sections 17-20.

(2). When applying for permission for the wholesale distribution of medicinal products, the applicant shall use the National Board of Health's pre-printed application form.

§ 5. An application or reapplication for a licence to wholesale distribution in accordance with article 39, paragraph 1, of the law on medicinal products processed within 90 days from the submission of a complete application.

(2). If the holder of a permit to the wholesale distribution of medicinal products is requesting amendment of the information specified in the authorization, treated the application within 30 days. In special cases, this period may be extended to 90 days.

§ 6. The National Board of health of the applicant may require further information with respect to the circumstances referred to in section 4, paragraph 1.

(2). If the Board of health require further information pursuant to paragraph 1, the deadlines laid down in § 5 shall be suspended until that information has been provided.

§ 7. The National Board of health shall issue the first permit to wholesale distribution after satisfying himself by a study carried out by its representatives, to information in the application corresponds to the actual situation.

§ 8. The holder of a permit to the wholesale distribution of medicinal products must not without health's permission to change the circumstances referred to in section 4, paragraph 1.

§ 9. Possession of a permit to manufacture or import medicines in accordance with article 1(1)(e); § 39, paragraph 1, of the law on medicinal products, also gives permission to wholesale negotiate those medicines.

(2). Possession of a permission for the wholesale distribution of medicinal products does not give permission to import or manufacture drugs, including produce multi packs or medicinal products for clinical trials, to change the drug's labelling or packaging or breaking of finished packages.

§ 10. The National Board of health shall establish the information is received by the registration under section 4, in the EU-data base, as the European Medicines Agency manages on behalf of the European Union.

Chapter 4 registering the dissemination of drugs § 11. In order to obtain registration as a facilitator of drugs under section 41 (c), paragraph 1, of the law on medicinal products, the applicant must:

Use the electronic form, as the National Board of health has made available

Specify the following information in the form: Name, company name and real address (2). A retailer must have a fixed address and contact information in Denmark.

(3). At the time of any change of the information provided under paragraph 1 shall inform the provider without undue delay National Board of health.

Chapter 5 good distribution practice § 12. All wholesale and retail sale shall be carried out in accordance with good distribution practices.

§ 13. Detailed guidelines on good distribution practice is published by the European Commission in the ' Guide to good distribution practice for medicinal products for human use ', which is also used for medicines for animals.

Quality assurance system



§ 14. Any wholesale dealer must establish and use an effective pharmaceutical quality assurance system, involving the management and the staff of the relevant departments in the company. Wholesale dealer must document in writing the quality assurance system, including describe responsibilities, workflow and risk management measures related to the company.

Organization and personnel




§ 15. Wholesalers and pharmacies, including hospital pharmacies, must have a competent and suitably qualified personnel. Thereof to be designated a quality person in charge who is responsible for the activity is exercised in accordance with the provisions of this Ordinance. The responsible person must have his time in the company of an adequately taking into account the activity of the company or at the pharmacy.

(2). Wholesale distributors shall appoint a management representative, who possesses the necessary qualifications, and who has the power and the responsibility to implement and maintain a quality assurance system.

§ 16. The hierarchical relationships shall be defined in an organisation chart. The responsibility of the personnel handling medicinal products shall be defined in job descriptions.

(2). The employees must be familiar with the principles and guidelines on good distribution practice.

Premises and equipment



§ 17. Premises and equipment must be designed, dimensioned, operated and maintained in such a way that they are suitable for their purpose, and thus to effective cleaning can be carried out.

§ 18. Storage rooms must be sufficiently large to allow for the maintenance of good order and complying with appropriate product flow, URf.eks. first in first out principle. A particular area must be calculated for the goods for destruction.

§ 19. Stock holding will be done at the storage conditions, laid down in any marketing authorisation or by the manufacturer. The temperature in the storage premises and equipment must be checked and documented.

§ 20. Medicinal products should be stored out of reach of unauthorized persons.

Receipt and delivery



§ 21. Wholesalers and pharmacies must ensure that they only receive deliveries of medicines from companies or persons within the EU/EEA has a licence to manufacture, import or wholesale distribution of medicinal products, or who is a pharmacist.

(2). If the medicinal product is received from another wholesaler, the wholesaler must verify that the supplier wholesaler complies with the principles and guidelines of good distribution practice. This includes checking if the supplier wholesaler is the holder of a permit to wholesale distribution.

(3). If the medicinal product is received from the manufacturer or the importer, the wholesaler must verify that the manufacturer or importer holds an authorization to manufacture.

(4). If the medicinal product is received through the dissemination, the wholesaler to verify that the relevant intermediary meet the established requirements for intermediaries.

§ 22. Wholesale distributors must ensure that the completed receive control for all supplies of medicinal products, which they receive from companies or persons within the EU/EEA has authorisation to manufacture, import or wholesale distribution of medicinal products, or who is a pharmacist. Receive control can only be carried out in Denmark.

§ 23. Wholesale distributors shall ensure that upon delivery within the EU/EEA of other medicinal products, other than those referred to in article 1, paragraph 2, no. 1, only delivers to companies or individuals who have a permit for the manufacture, importation, wholesale or retail distribution of medicines, or that have a pharmacy, see. However, paragraphs 2 to 6.

(2). In addition to those referred to in paragraph 1, the recipients can medicinal products for clinical trials is provided to the physician, dentist, or veterinarian, who is responsible for the practical implementation of the experiment, when the experiment is approved pursuant to section 88, paragraph 1, of the law on medicinal products.

(3). In addition to those referred to in paragraph 1, the recipients can sera and medicinal products derived from blood, vaccines and immunological test preparations from the Danish State Serum Institute and the Veterinary Institute delivered to physicians, dentists and veterinarians, see. section 30 of the law on drugs, the Executive order on preparations and studies, etc. by the Danish State Serum Institute and executive order on preparations and studies at the Technical University of Denmark.

(4). In addition to those referred to in paragraph 1, the recipients can medical samples with health's authorisation of the holder of the marketing authorisation or his representative, shall be handed over to doctors, dentists and veterinarians, see. notice of distribution of samples of medicinal products. The National Board of health may determine the conditions of the permission.

(5). In addition to those referred to in paragraph 1, the recipients can radiopharmaceuticals supplied to nuclear medicine departments at hospitals, see. notice of radiopharmaceuticals and the Executive order on handling, etc. of radioactive drugs in hospitals.

(6). For institutions, companies, etc. can be of technical, analytical and educational purposes (non-pharmaceutical purposes) provided medicines after a written order signed by the head of the institution or by a person authorised to do so.

Control certificate



§ 24. For the supply of medicinal products from other EU/EEA countries, the receiving company or the receiving pharmacist ensure that the shipment is accompanied by an inspection certificate referred to in article 6. However, paragraph 2.

(2). For the supply of medicinal products for clinical trials or drugs that are sold or dispensed pursuant to § 29 (1) or section 30 of the law on medicinal products and which is not covered by a marketing authorisation, can control the proof shall be replaced by the corresponding documentation.

(3). If a shipment is not accompanied by the in paragraph 1 or 2 above documentation, the receiving company or the receiving pharmacist before further distribution or dispensing to ensure that every batch is controlled within the meaning of section 35 of the Ordinance on the manufacture and importation of medicinal products and intermediate products.

Documentation for received and delivered medicines



§ 25. Holders of an authorisation for wholesale distribution of medicinal products must keep documentation for all received drugs in the form of information about: 1) date of receipt, 2) precise indication of the name of the medicinal product, 3) received quantity 4) pharmaceutical form, strength and package size, 5) the supplier's name and address, as well as 6) name and address of the recipient.

(2). Upon receiving the drugs from manufacture, importer or other wholesale dealer must, in addition to the documentation referred to in paragraph 1 shall also contain information on the batch number and expiry date.

section 26. Holders of an authorisation for wholesale distribution of medicinal products must hold and enclose documentation for all supplied drugs to pharmacies as well as to businesses and individuals, according to Danish or foreign legislation are authorized to supply medicinal products to the users, including medicinal products exported to countries outside the EU/EEA (third countries), in the form of information about: 1) date of delivery, 2) precise indication of the name of the medicinal product , 3) delivered quantity 4) pharmaceutical form, strength and package size, 5) the name and address of the recipient as well as 6) vendor's name and address.

(2). In the case of deliveries of drugs to other wholesale dealer must, in addition to the documentation referred to in paragraph 1 shall also contain information on the batch number and expiry date.

(3). In the case of deliveries of medicines for animals, in addition to the documentation referred to in paragraph 1 shall also contain information on the batch number and expiry date.

§ 27. Pharmacies, including hospital pharmacies, for all received drugs keep documentation in the form of information about: 1) date of receipt, 2) precise indication of the name of the medicinal product, 3) received quantity 4) pharmaceutical form, strength and package size, 5) the supplier's name and address, as well as 6) name and address of the recipient.

(2). Upon receipt of prescription medicines for animals, in addition to the documentation referred to in paragraph 1 shall also contain information on the batch number.

section 28. Pharmacies must keep documentation for all supplied prescription drugs to animals in the form of information about: 1) date of delivery, 2) precise indication of the name of the medicinal product, 3) supplied quantity 4) pharmaceutical form, strength and package size, 5) the supplier's name and address 6) name and address of the recipient, 7) batch number and 8) the name and address of the prescribing veterinarian and a copy of the prescription.

section 29. The in §§ 25-28 said documentation shall be provided in the form of purchase or sales invoices, accompanying papers, etc., and wholesalers and pharmacies, including hospital pharmacies, must ensure that it is available to the Board of health for 5 years.

section 30. Wholesale distributors of medicinal products for animals and pharmacies should at least once a year, make a proven accurate review, where a record of received, supplied and supplied drugs to animals must be read in conjunction with the inventory, and a report shall be drawn up of any discrepancies. For dispensaries relates to the requirement, however, only prescription medicines for animals.

(2). Wholesale dealers should let the report referred to in paragraph 1 shall be available to the health protection agency for 3 years.

(3). Pharmacies must let the report referred to in paragraph 1 shall be available to the Board of health for 5 years.

Complaints and product recall



section 31. There must be an effective system for the treatment of cases involving complaints and deficiencies, which documents how these have been dealt with, and which makes it possible to revoke the medicinal products in the distribution network immediately and at any time after orders from the health protection agency or in cooperation with the manufacturer, the importer or the holder of the marketing authorisation for the medicinal product concerned.

Counterfeit medicines




section 32. Wholesalers and pharmacies to ensure that medicinal products which are or can be forged, be kept separate from other drugs. Medicinal products must also be marked, so it is clear that they are not for sale or dispensing.

Storage, distribution and receive control after contract



section 33. Wholesale dealer (contract gives) can leave that to the other (contract acceptors) to perform reception (including receiving control), stock holding and distribution, provided that: 1) contract Acceptor has a wide authorization pursuant to § 39, paragraph 1, of the law on medicinal products or other relevant authorisation under the legislation of another EU/EEA country, 2) there is a written contract between the contract giver and the contract acceptor for each task, 3) the dealer's contract and contract's area of responsibility is clear from the contract , 4) according to the contract, that the contract Acceptor has a duty to comply with good distribution practice, 5) according to the contract, that the contract does not take may entrust the execution of tasks to a third party without consent from the contract giver and 6) according to the contract, the contract takes, if the latter has a permit in accordance with the law of another EU/EEA country, see. Nr. 1, agrees that the health protection agency controls the company.

(2). The final recipient control by supplies from other EU/EEA countries can only be carried out in Denmark.

(3). Contract holder can only entrust the execution of tasks to third parties by following the provisions of this Ordinance.

(4). The provision in paragraph 1 shall apply mutatis mutandis in the extradition of drug samples to doctors, dentists and veterinarians, is happening on behalf of the holder of the marketing authorisation referred to in article 6. Article 23, paragraph 4.

Self-inspection



§ 34. Wholesale distributor shall at regular intervals carry out self-inspection as part of the quality assurance system in order to monitor the implementation and respect of good distribution practices as well as to propose any changes which may be necessary.

(2). There must be records of completed self inspections and corrective actions.

(3). Self inspection program shall include audits of any contract acceptors.

Miscellaneous



section 35. Multi seals may be broken only by hospital pharmacies, drug stores and distributing veterinarians. Multi packs, consisting of individual packages of a medicinal product to the animals, must, however, be broken by pharmacies, Technical University of Denmark, holders of the National Board of Health's permission for retail sale of medicines for animals, who are busy in dispensing group ' HV ' in the Health Agency's register of authorised medicinal products, and the holders of a permit under section 39, paragraph 1, of the law on medicinal products, to debate, to users of medicines for animals.

(2). Pharmacies and hospital pharmacies may also break the medicine packages in accordance with the rules laid down in the Decree on separation of medicine packages to animals and Decree on dose dispensing of medicinal products.

§ 36. Medicinal products whose shelf life has been exceeded, or which in any case cannot be assumed to conform to the applicable quality requirements, should not be extradited. Such drugs must be returned to the manufacturer or supplier or destroyed safely.

Chapter 6 good distribution practices for the dissemination section 37. It is incumbent upon a mediator to conduct mediation in accordance with good distribution practices for intermediaries.

section 38. If the medicinal product is disseminated via a wholesaler, retailer, verify that the supplier wholesaler complies with the principles and guidelines of good distribution practice. This includes checking if the supplier wholesaler is the holder of a permit to wholesale distribution.

(2). If the medicinal product is disseminated via the manufacturer or importer, the retailer shall verify that the manufacturer or importer holds an authorization to manufacture or importation of medicinal products or intermediates.

(3). If the medicinal product is disseminated through another intermediary, the intermediary must verify that the relevant intermediary meet the established requirements for intermediaries.

(4). The provider must verify that the receiver has a relevant permit.

Quality assurance system



§ 39. A mediator must establish and use an effective pharmaceutical quality assurance system, involving the management and the staff of the relevant departments in the company. The provider must provide evidence of the quality assurance system, including in writing, describe the responsibilities, workflow and risk management measures related to the company.

Incoming and outgoing medicinal products



§ 40. A mediator should ensure that they facilitated the medicinal products covered by a marketing authorisation in an EU or EEA country.

§ 41. A facilitator must keep documentation for all incoming and outgoing units, provided medicines in the form of information about: 1) date of dissemination, 2) precise indication of the name of the medicinal product, 3) disseminated quantity 4) pharmaceutical form, strength and package size as well as 5) name and address of the supplier and the recipient's revocation



§ 42. A facilitator must have an effective system that ensures implementation of a withdrawal from the market in accordance with orders from the health protection agency or in cooperation with the manufacturer, the supplier of the medicinal product in question or the holder of the marketing authorisation for the medicinal product concerned.

Deletion from the list of registered intermediaries



section 43. If the health protection agency delete an intermediary from the list under section 41 c, paragraph 3, of the law on medicines, National Board of health shall notify the person concerned thereof.

Chapter 7 Inspection, disclosure of information, etc.

§ 44. After any inspection under section 44 (1) of the law on medicines, National Board of health shall prepare a report on whether the principles and guidelines of good distribution practice are complied with. The contents of these inspection reports shall be communicated to the affected wholesale dealer or retailer who shall keep the report on the company. Before the report is adopted, provides Health Agency concerned to inspect the company the opportunity to submit comments.

(2). Following a reasoned request from a competent authority in another EU/EEA country or from the European Medicines Agency sends Health Agency electronically the reports mentioned in paragraph 1, which relates to the wholesale distributors of medicinal products for human use or active substances for medicinal products for human use, to the appropriate authority in another EU/EEA country or to the European Medicines Agency.

(3). The health protection agency introduces information about permissions given under this Ordinance in the EU database, which the agency manages on behalf of the European Union.

§ 45. Within 90 days of an inspection as referred to in section 44 shall issue the health protection agency a certificate of good distribution practice for wholesale distributor, if the conclusion after the inspection visit is that the person concerned is in compliance with the principles and guidelines of good distribution practice.

(2). The health protection agency leave referred to in paragraph 1, the certificates they issue in a Community database, such as the European Medicines Agency manages on behalf of the European Union.

(3). If the conclusion of an inspection as referred to in paragraph 1 is that the wholesale distributor does not comply with the principles and guidelines of good distribution practice, introduced this piece of information in the Community database referred to in paragraph 2.

§ 46. The National Board of health must have a monitoring system that includes an inspection at suitable intervals based on risk of importers and distributors, which is domiciled in Denmark, and an effective follow-up.

§ 47. At the request of the European Commission or another EU/EEA country, the National Board of health to present all relevant information about the individual permissions to the wholesale distribution, issued pursuant to section 39, paragraph 1, of the law on medicinal products.

section 48. If the National Board of health shall suspend or revoke a permission for the wholesale distribution of medicinal products within the meaning of section 41 of the law on medicinal products, it shall inform the National Board of health shall immediately inform the other EU/EEA countries and the European Commission.

§ 49. Where a competent authority in another EU/EEA country considers that the holder of a permit to the wholesale distribution of medicinal products no longer fulfils the conditions for the authorization and shall inform the National Board of health to that effect, National Board of health shall take the necessary measures and inform the Member State concerned and the European Commission on the decisions taken and the reasons therefor.

§ 50. If a medicinal product in the context of an action for revocation, is suspected to pose a serious risk to public health, and was first identified in Denmark, the Danish National Board of health shall immediately ensure that emitted a quick warning to all EU/EEA countries ' competent authorities and all relevant actors in the supply chain in Denmark.

(2). In the case of medicinal products as referred to in paragraph 1 must be assumed to have reached patients, the health protection agency publishes or wholesale dealer within 24 hours a message to the public about the suspected quality defect or forgery, the possible risks and recommendations for patients.

§ 51. The National Board of health may grant derogations from one or more of the provisions of this Ordinance, if exceptional circumstances justify.

Penalty-and entry-into-force provisions



§ 52. Unless a higher penalty is inflicted upon other law punishable with fine anyone who violates section 8, section 12, sections 14-22, section 23, paragraph 1, article 24, paragraphs 1 and 3, § § 25-34, section 35 (1) and §§ 36-42.


(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

§ 53. The notice shall enter into force on the 1. January 2013.

(2). Executive Order No. 823 of 1. August 2012 for the distribution of medicinal products should be repealed.

(3). Persons and businesses, providing medicines, and that started their activities in the 1. January 2013, must register with the Health Agency by 1. March 2013.

The Ministry of health and prevention, 18. December 2012 Astrid Krag/Kirstine f. Hindsberger Official notes 1) Ordinance contains provisions implementing parts of the European Parliament and Council Directive 2001/82/EC of 6 May 2003. November 2001 establishing a Community code relating to veterinary medicinal products, the official journal of the European Communities 2001, nr. L 311, p. 1, as last amended by European Parliament and Council Regulation (EC) no 596/2009 of 18. June 2009, the official journal of the European Union 2009, nr. L 188, p. 14, and parts of the European Parliament and Council Directive 2001/83/EC of 6 May 2003. November 2001 establishing a Community code relating to medicinal products for human use, the official journal of the European Communities 2001, nr. L 311, p. 67, as last amended by European Parliament and Council directive 2010/84/EU of 15. December 2010, the official journal of the European Union 2010, nr. L 348, p. 74, and European Parliament and Council directive 2011/62/EU of 8. June 2011, official journal 2011, nr. L 174, p. 74.