Chapter 1	Conventing of the Bekendom Decision
Chapter 2	Definitions
Chapter 3	Permission for wholessnegotiation
Chapter 4	Good Deployment Practices
Chapter 5	Inspection, forwarding of information, etc.

Publication of the distribution of medicinal products 1)

In accordance with paragraph 29, paragraph 1. 3, section 40, paragraph. 1, 3 and 4, section 43, section 92 (3). 3, and section 104 (3). Three, in the law. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 534 of 17. June 2008 and Law No 464 of 18. May 2011 and in accordance with section 38 (4). 2, section 43 and section 72, paragraph 1. 2, in the case of apothecary, cf. Law Order no. 855 of 4. August 2008 shall be determined :

Chapter 1

Conventing of the Bekendom Decision

§ 1. This notice covers wholessance of medicinal products and the detailed discussion of medicinal products from pharmacies, including storage, cf. however, paragraph 1 2.

Paragraph 2. The announcement shall not apply to :

1) retail negotiation of homeopathic medicinal products, anthropootic medicinal products, natural medicinal products, traditional plantings, vitamin and mineral preparations and medicinal gases ; and

2) detailed discussion of medicinal products from the sale of small-time purchasers.

§ 2. The announcement shall apply to undertakings and persons who have received the consent of the Health Board for the wholesalment of medicinal products after Article 39 (3). 1, in the case of medicinal products, for applicants for such authorization, where this is explicitly stated in the individual provisions and in pharmacies, including medical potheses.

Chapter 2

Definitions

§ 3. In this notice, the following terms are used in the meanings :

1) Good distribution practices (GDP) : the part of the quality assurance that ensures that the characteristics of medicinal products are not affected by distribution and that defective medicinal products can be traced and revoked.

2) Distribution : Any activity that consists in the wholesale or detailed negotiation of medicinal products.

3) Wholesaler : A company or person who is conducting or retracing the wholesaler.

4) Wholessnegotiation : Any activity that consists of receiving, storing, or providing medicinal products within EU/EEA or from exporting medicinal products to third countries, with the exception of the supply of medicinal products to users.

5) Retailer : A company or a person who is conducting a retailer.

6) Retail : Any type of activity that consists of receiving, storing, selling and supplying medicinal products to users.

7) Provider : A manufacturer, an importer, or a wholesaler who makes delivery to the next part of the distribution chain.

8) Importer : anyone who has the authority to authorize the import of medicinal products after Article 39 (3). 1, in the law on medicinal products, and pharmacies, including medical potees, which are introducing medicinal products.

9) Imports : the import of medicinal products from a country outside EU/EEA (non-member country).

10) Manufacleer : The company or person authorized by the Health Board for the manufacture of medicinal products in accordance with section 39 (5). 1, in the case of medicinal products, and whose qualified person has made the final release of the batch, and pharmacies, including medical potheses, who carry out such release.

11) Quality assurance system : The system to ensure that distributed medicinal products comply with the rules of this notice that the storage conditions of any time are fulfilled, including during transport, that contamination by or other products is avoided, the medicinal products are extraditable to the appropriate person and they can be traced.

12) Proof of proof : the party signed by the expert at the manufacturer of the person responsible for the importation or in the contract agent that the medicinal product, including intermediate products and active substances, has been manufactured in accordance with good, manufacturing practices and satisfies the requirements of the marketing authorization.

13) Experts person : A person who satisfies the minimum requirements for scientific and technical qualifications laid down in Article 49 (1). Two to three, in Directive 2001 /83/EC, or Article 53 (3). 2-3 of Directive 2001 /82/EC and, where relevant, Article 13 (1). 2, in Directive 2001 /20/EC.

14) Receive control : ensuring compliance with the conditions of the medicinal product under transit, that the documentation required under this notice shall be included and that the medicinal products supplied are equivalent to that of the order.

Chapter 3

Permission for wholessnegotiation

§ 4. To obtain consent for the wholessals of medicinal products in accordance with section 39 (3). 1, in the law of medicinal products, the applicant shall :

1) have a sufficient staff meeting the requirements of section 13-14 ; and

2) have rooms and equipment meeting the requirements of sections 15 to 18.

Paragraph 2. In the case of an application for authorization for the wholesalment of medicinal products, the applicant shall apply the pre-printed application form of the health management system.

§ 5. An application or a reapply permit for wholessnegotiation in accordance with section 39 (4). 1, in the case of medicinal products, shall be treated within 90 days of the submission of a full application.

Paragraph 2. If the holder of a licence for the wholessals of medicinal products requests a modification of the information given in the authorization, the application shall be processed within 30 days. This period may be extended in exceptional cases to 90 days.

§ 6. The Board of Health may, by the applicant, request further information in respect of the matters referred to in section 4 (4). 1.

Paragraph 2. If the Board of Health requires further information in accordance with paragraph 1. 1, suspend the deadlines in section 5 until such information has been provided.

§ 7. The Board of Health shall not issue an authorisation for wholesalthcare after having secured a study by its representatives, that information in the application corresponds to the actual facts.

§ 8. The holder of a licence for the wholesalthcare of medicinal products shall not alter the conditions set out in section 4 (4). 1.

§ 9. Possession of a permit for the manufacture or introduction of medicinal products in accordance with the terms of cf. § 39, paragraph. 1, in the case of medicinal products, also permits the wholeslet of wholessnegotiate the medicinal products concerned.

Paragraph 2. The possession of a licence for the wholes-use of medicinal products does not permit the introduction or manufacture of medicinal products, including the manufacture of multipackaged or medicinal products for clinical trials, to change the labelling or packaging of the medicinal product or to the manufacture of medicinal products ; Breaking finished packing.

Chapter 4

Good Deployment Practices

§ 10. All wholesale and retail negotiations must be carried out in accordance with good distribution practices.

§ 11. Detailed guidelines for distribution are shown in the ' Guidelines in good distribution practice for humane use medicinal products published by the European Commission in the Official Journal of the European Communities. C 63, s. 4, which may also be used for medicinal products for animals.

Quality assurance system

§ 12. Any wholesale negotiator shall establish and implement an effective quality assurance system active involving the management and staff of the affected departments in the establishment.

Organization and personnel

§ 13. Wholesalers and pharmacies, including medical harpotheses, must have a competent and adequately qualified staff. It shall be appointed to appoint a person responsible for the activity carried out in accordance with the provisions of this notice. The responsible person shall have its own operation in an adequate amount, taking into account the activity of the company or at the pharmacy.

Paragraph 2. Wholesale distributors shall designate a management representative who possesses the necessary qualifications and has the power and responsibility for implementing and maintaining a quality assurance system.

§ 14. The hierarchical conditions must be defined in an organisation plan. The area of responsibility for the staff dealing with medicinal products must be defined in job descriptions.

Paragraph 2. The employees must be aware of the principles and guidelines that apply to good distribution practices.

Rooms & Equipment

§ 15. Premises and equipment must be designed, dimensioned, used and maintained so that they are suitable for their purpose, and so that efficient cleaning can be performed.

§ 16. Storerooms must be sufficiently large to enable the maintenance of good order and compliance with appropriate flow-flow, for example, first in principle. A specific area must be intended for the destruction of goods.

§ 17. Storage teams shall be carried out by the storage conditions as determined in a possible marketing authorization or by the manufacturer. The temperature of storerooms and refrigeration equipment must be checked and documented.

§ 18. Medicinal products shall be kept inaccessible to the unauthorized person.

Delivery and Receipt

§ 19. Wholesalers and pharmacies shall ensure that they alone receive supplies of medicinal products from companies or persons who are authorized to manufacture, import or wholesalers the medicinal products, or which are a pharmacy.

20. Wholesalers shall ensure that receiving checks are carried out for all supplies of medicinal products for which they are granted from undertakings or persons authorized to manufacture, import or wholesalers, of medicinal products, or is a pharmacy.

§ 21. Wholesalers shall ensure that they are provisioning within the EU/EECE of other medicinal products other than those referred to in section 1 (1). 2, no. 1, alone supply to undertakings or persons authorized to manufacture, import, wholesale or retailer of medicinal products, or as a pharmacy, cf. however, paragraph 1 2-6.

Paragraph 2. In addition to the provisions of paragraph 1, 1 the recipients of the said beneficiaries may be delivered to the doctor, dentistry or veterinarian responsible for the practical implementation of the study when the study is approved in accordance with Article 88 (2). 1, in the law on medicinal products.

Paragraph 3. In addition to the provisions of paragraph 1, 1 the recipients of the said recipients may serve sera and medicinal products from blood, vaccines and immunological test preparations from the State Serum Institute and the Technical University of Denmark are delivered to doctors, dentists and veterinarians, cf. notification of preparations and studies, etc., at the State Serum Institute and the announcement of preparations and studies at the Danish Technical University of Denmark (Time. Denmark's Food Research.

Paragraph 4. In addition to the provisions of paragraph 1, 1 the recipients of the medicinal product of the marketing authorization of the marketing authorization holder or his representative shall be supplied to doctors, dentists and veterinarians, in accordance with the requirements of the health board. notification of the supply of medicinal products for medicinal products. The Board of Health may lay down terms of the permit.

Paragraph 5. In addition to the provisions of paragraph 1, 1 mentioned recipients may be supplied to nuclear medical facilities in hospitals in hospitals, cf. the notification of radioactive medicinal products and the notification of handling and so on of radioactive medicinal products in hospitals.

Paragraph 6. For establishments, establishments and so on, technical, analytical and educational purposes (non-medicinal purposes) are provided on a written order signed by the institution of the institution or by a person authorised to do so.

Proof of control

§ 22. For the supply of medicinal products from other EU/EEA countries, the receiving company or the receiving dispensary shall ensure that the delivery is accompanied by a certificate of control, cf. however, paragraph 1 2.

Paragraph 2. For the supply of medicinal products for clinical trials or medicinal products sold or delivered pursuant to section 29 (5), Paragraph 1, or Section 30 of the medicinal products which are not subject to a marketing authorisation, may be replaced by correspondence by the same token.

Paragraph 3. If a shipment is not accompanied by the delivery set out in paragraph 1. in the case of documents referred to in paragraph 1 or 2, the receiving company or the receiving dispensary must ensure that any batch is checked under Section 35 of the publication of medicinal products and the importation of medicinal products ; intermediate products.

Documentation of susceptible and supplied medicinal products

-23. The holders of a licence for the wholes-use of medicinal products shall keep evidence of all received medicinal products, in the form of information on :

1) date of receipt,

2) precise indication of the name of the medicinal product,

3) received quantity,

4) the form of medicinal products, strength and liabilities, and

5) the name and address of the supplier.

Paragraph 2. In the case of the receipt of medicinal products from manufacturing, importer or other wholesaler, the documentation must, in addition to the provisions of paragraph 1, 1 shall also specify batch number and expiry date.

§ 24. holders of a licence for the wholes-use of medicinal products shall keep and maintain the documentation of all the medicinal products supplied to pharmacies and to undertakings and persons who are authorized under Danish or foreign law to extradite ; medicinal products intended for users, including medicinal products exported to countries outside EU/EEA (third countries), in the form of information on :

1) Date of delivery,

2) precise indication of the name of the medicinal product,

3) quantity supplied,

4) the form of medicinal products, strength and liabilities, and

5) the name and address of the recipient.

Paragraph 2. In the case of deliveries of medicinal products for the second wholesaler, the documentation must be provided for in the first paragraph 1 shall also specify batch number and expiry date.

Paragraph 3. In the case of deliveries of medicinal products for animals, the documentation must be provided for in paragraph 1 shall also specify batch number and expiry date.

§ 25. Pharmaceuticals, including medical carers, must keep records of 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) the form of medicinal products, strength and liabilities, and

5) the name and address of the supplier.

Paragraph 2. In the case of receipt of prescription medicinal products to animals, the evidence referred to in paragraph 1 shall be that : 1 may include batch number information.

SECTION 26. Pharmacies must keep evidence of all supplied prescription medicinal products to animals in the form of information on :

1) Date of delivery,

2) precise indication of the name of the medicinal product,

3) quantity supplied,

4) the form of medicinal products, strength and liabilities,

5) the name and address of the recipient,

6) batch number and

7) the name and address of the animal doctor and copy of the prescription.

§ 27. The documentation referred to in section 23 to 26 may be available in the form of the purchase or sales invoices, computer data, or any other form, and wholesalers and pharmacies, including medical potheses, must ensure that it is available for : The Board of Health for five years.

§ 28. The wholesalers of medicinal products for animals and pharmacies must at least once a year undertake an accurate review where a record of received, supplied and supplied medicinal products to animals must be compared with the stock inventory, and a report shall : to be prepared over any discrepancies In the case of pharmacies, however, the requirement applies only to prescription-only medicines for animals.

Paragraph 2. The wholesalers shall leave it in paragraph 1. 1 mentioned report shall be available to the Board of Health for three years.

Paragraph 3. Pharmacies shall leave it in paragraph 1. 1 mentioned report shall be available to the Board of Health for five years.

Reclamations and retracts

§ 29. An effective system for the processing of cases relating to advertising and defects, which documents the manner in which these have been dealt with and which makes it possible to revoke medicinal products in the distribution network immediately and on any matter, at the time, at the request of the Board of Health or in cooperation with the manufacturer, the importer or holder of the marketing authorization holder for the medicinal product concerned.

Falsied medicinal products

-$30. Wholesalers and pharmacies shall ensure that medicinal products that are or may be falsified are kept separate from other medicinal products. In addition, the medicinal products must be labelled so clearly that they are not for sale or extradition.

Inventory, Distribution and Receive Control by Contract

§ 31. Contractor (contract grants) may leave to other (contractors) to carry out the inventory, distribution and receiving checks, provided that :

1) the contract shall have a comprehensive permit in accordance with section 39 (4). 1, in the law of medicinal products or other relevant authorisation, in accordance with the legislation of another EU/EEA country,

2) there is a written contract between the contract of contract and contract for each task,

3) the contract of contracts and the contract of the contract shall be clearly stated in the contract ;

4) it is stated in the contract that the contract has a duty to comply with good distribution practices,

5) it is stated in the contract that the contract does not allow the execution of tasks to third parties without the consent of the contract, and

6) it is stated in the contract that the contract may, if this has a licence under the legislation of another EU/EEA country, cf. no. 1, agree to the Board of Health controlling the company.

Paragraph 2. The final receive checks provided for in the case of deliveries from other EU/EEA countries may be carried out in Denmark.

Paragraph 3. Contracts may only delegate the execution of tasks to third parties by following the provisions of this notice.

Paragraph 4. The provision in paragraph 1 shall be 1 shall apply mutatis mutandis by the supply of medicinal samples to doctors, dentists and veterinarians, which shall be made on behalf of the marketing authorization holder, cf. Section 21 (1). 4.

Self-Inspection

§ 32. The wholesale distributor shall periodically carry out inspection as part of the quality assurance system in order to verify the implementation and compliance of the principles of good distribution practice as well as to propose the amendments which may be : necessary.

Paragraph 2. Records must be carried out of completed self-inspections and corrective actions.

Paragraph 3. The inspection programme shall include the audit of any member of the contract holders.

Misc.

§ 33. Multi-packs may be broken only by paramedics, drug pots and distributors of medical products. However, multipaces consisting of individual packs of a medicinal product for animals may be broken by pharmacies, Danish Technical University, holders of the health management licence for the retailer of medicinal products for the supply of supply to animals, ' HV ` in the health management register of authorized medicinal products and holders of authorization after paragraph 39 (5). 1, in the case of medicinal products, for the distribution of medicinal products to the users of production animals.

Paragraph 2. Pharatics, including the Pharmacy of the Bioscientific faction, and sickness potecian must also breach medicinal products in accordance with the rules in the notice on the splitting of medicinal products for animals and for the dose dispensation of : medicinal products.

§ 34. Medicinal products, whose durability time has been exceeded, or which may not be presumed to respond to the quality requirements applicable, may not be handed over. Such medicinal products must be returned to the manufacturer or the supplier or be destroyed in a responsible manner.

Chapter 5

Inspection, forwarding of information, etc.

$35. After all inspection in accordance with section 44 (4), 1, in the law on medicinal products, the Board of Health shall prepare a report on the application of the principles and guidelines for the proper distribution practices. The contents of these inspection reports shall be communicated to the wholesaler concerned, who shall keep the report on the premises.

Paragraph 2. If the conclusion of an inspection referred to in paragraph 1 is carried out, 1 is that a wholesaler of medicinal products for human beings or the active drugs for human beings for human beings does not comply with the principles of good distribution practice, this information shall be introduced into the EU database, as the European Medicines Agency, administered on behalf of the Community.

Paragraph 3. On the basis of a reasoned request from an authority of another EU/EEA country or from the European Medicines Agency, the Board of Health shall electronically transmit to the Board of Health in electronic means. The reports referred to in paragraph 1 concerning wholesalers of medicinal products for human beings or the active substances for human beings shall be referred to in another EU/EEA country or to the European Medicines Agency.

§ 36. At the request of the European Commission or any other EU/EEA country, the Board of Health shall provide all relevant information concerning the individual authorisations for wholesalthcare issued pursuant to section 39 (2). 1, in the law on medicinal products.

§ 37. If the Board of Health shall suspend or withdraw a licence for the wholesalthcare of medicinal products under Section 41 of the Act on Medicinal Products, the Health Agency shall immediately inform the other EU/EEA countries and the European Commission.

§ 38. Where a competent authority in another EU/EEA country considers that the holder of a licence for the wholesalthcare of medicinal products no longer meets the conditions for its authorisation and notifies the Board of Health, they shall take the Board of Health and the measures taken and shall inform the Member State and the European Commission of the decisions taken and the reasons for it.

§ 39. The Board of Health may dispense with one or more of the provisions of this notice, in so far as the specific conditions are referred to.

Punishment and entry into force

§ 40. Unless higher penalties are imposed on other legislation, the penalty shall be penalized for the penalty which violates § 8, § 10, § 12 20, section 21, paragraph 1. Paragraph 1, paragraph 22, paragraph 22. One and three, section 23-32, section 33, paragraph. 1, and § 34.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 41. The announcement shall enter into force on 3. August 2012.

Paragraph 2. Publication no. 1243 of 12. December 2005 on the distribution of medicinal products is deleted.

1) The announcement contains provisions which implement parts of Directive 2001 /82/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of veterinary medicinal products, the EC Official Journal of 2001, no. L 311, s. Regulation 1, as last amended by Regulation (EC) 596/2009 of 18 of the European Parliament and of the Council. June 2009, EU-Official Journal 2009, nr. In 188, s. 14, and parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. Last amended by Directive 2010 /84/EU of the European Parliament and Council Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, s. Directive 74, and the European Parliament and Council Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, s. 74.