Chapter 1	Conventing of the Bekendom Decision
Chapter 2	Definitions
Chapter 3	Permission for wholessnegotiation
Chapter 4	Registration of the dissemination of medicinal products
Chapter 5	Good Deployment Practices
Chapter 6	Good distribution practices for dissemination
Chapter 7	Inspection, forwarding of information, etc.

Publication of the distribution of medicinal products 1)

In accordance with paragraph 29, paragraph 1. 3, section 39 a, paragraph. 1, section 39 b, section 41 c, section 41 d, section 43 a, § 92 (2). 3, and section 104 (3). Three, in the law. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 1258 of 18. December 2012, 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, as amended by law no. 1258 of 18. December 2012 :

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, herbal medicinal products, traditional herbal medicinal products, vitamin and minerals and medical gases ; and

2) retailers of pharmaceutical products from pharmacies or retailers authorised to sell hand-purchase medicinal products in accordance with section 39, paragraph 1. 1, in the law on medicinal products.

§ 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.

Paragraph 2. The notice shall also include, where this is explicitly stated in the individual provisions, intermediaries of medicinal products registered after Article 41 b (1). 1, in the law on medicinal products.

Chapter 2

Definitions

§ 3. For the purposes of this notice :

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 form of activity consisting of wholesale or retailor of medicinal products.

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

4) Wholessnegotiation : Any activity that consists of buying, selling, receiving, storing, or supplying medicinal products within EU/EEA or 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) Qualisible person : A person designated by the company to ensure that the company complies with applicable rules for good distribution practices.

15) 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.

16) Premedications of medicinal products : an undertaking or a person making the dissemination of medicinal products.

17) Dissemination of medicinal products : Any form of establishment in connection with the purchase and sale of medicinal products, other than wholesale proceedings, which do not include physical handling, but is to negotiate independently and on behalf of a different legal or physical ; Person.

18) Falsished medicinal product : any medicinal product with a disregarding description of :

a) its identity, including its packaging and labelling, its name or its composition, in respect of any ingredient, including formulants, and the strength of these constituents,

b) its origin, including its manufacturing, its manufacturing country, its country of origin or the holder of the marketing authorisation ; or

c) its history, including records and documents relating to the distribution ducts used.

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 15 to 16 ; and

2) have rooms and equipment meeting the requirements of section 17-20.

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.

§ 10. The Board of Health shall establish the information received by the registration after Article 4 of the EU database which the European Medicines Agency administers on behalf of the European Union.

Chapter 4

Registration of the dissemination of medicinal products

§ 11. In order to obtain the registration of medicinal products as referred to in Article 41 c (1), 1, in the law of medicinal products, the applicant shall :

Applying the electronic form made available to the Health Services

Acct the following information in the form : Name, company name and address

Paragraph 2. A forefront must have a fixed address and contact information in Denmark.

Paragraph 3. Any modification of the information provided under paragraph 1. 1 shall inform the Board of Directants without undue delay.

Chapter 5

Good Deployment Practices

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

§ 13. Detailed guidelines for good distribution practices have been published by the European Commission in 'Guidelines in good distribution practice for humane use', which is also used for medicinal products for animals.

Quality assurance system

§ 14. Any wholesale negotiator shall establish and use an effective quality assurance system that actively involves the management and the staff of the affected departments in the establishment. The Enforcement Vendor must document the quality assurance system in writing, including the description of areas of responsibility, workflow and risk management measures related to the company.

Organization and personnel

§ 15. Wholesalers and pharmacies, including medical harpotheses, must have a competent and adequately qualified staff. It shall be designated a responsible 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.

§ 16. 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

§ 17. 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.

§ 18. 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.

§ 19. 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.

20. Medicinal products shall be kept inaccessible to the unauthorized person.

Receipt and Delivery

§ 21. 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.

Paragraph 2. If the medicinal product has been received from another wholesaler, the wholesaler shall check that the supplier wholesaler complies with the principles and guidelines of good distribution practices. This includes checking whether the supplier wholesaler is the holder of a licence for wholesale negotiation.

Paragraph 3. If the medicinal product has been received from the manufacturer or importer, the wholesaler shall verify that the manufacturer or importer is entitled to a permit for the manufacture.

Paragraph 4. If the medicinal product has been received through dissemination, the wholesaler shall verify that the intermediary in question meets the requirements laid down for intermediaries.

§ 22. 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. Receive checks may be carried out in Denmark alone.

-23. 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 be provided with blood, vaccines and immunological test preparations from the State Serum Institute of the State and the Veterinary Institute to doctors, dentists and veterinarians, cf. section 30 of the Act on Medicinal Products, Notice of Medicinal Products and Studies, etc., at the State Serum Institute and proclamations of preparations and studies at the Danish University of Denmark.

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

§ 24. 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

§ 25. 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,

5) the name and address of the supplier ; and

6) the name and address of the recipient.

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.

SECTION 26. 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,

5) the name and address of the recipient,

6) the name and address of the supplier.

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.

§ 27. 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,

5) the name and address of the supplier ; and

6) the name and address of the recipient.

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.

§ 28. 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) name and address of the supplier ;

6) the name and address of the recipient,

7) batch number and

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

§ 29. The documentation referred to in section 25 to 28 of that document shall be available in the form of purchase or sales invoices, accompanying papers, etc., and wholesale distributors and pharmacies, including medical potheses, shall ensure that it is available to the Board of Health for five years.

-$30. The wholesalers of medicinal products for animals and pharmacies must at least once a year make a documented precise examination where a record of the received, supplied and supplied medicinal products must be kept with the stock inventory, and one report shall be prepared on any inconsistencies 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

§ 31. 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, the time following orders from the Board of Health, or in cooperation with the manufacturer, the importer or holder of the marketing authorization for the medicinal product concerned.

Falsied medicinal products

§ 32. 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

§ 33. The enwholesseller (contract grants) may leave to other (contractors) to perform receipt (including receiving checks), storage teams and distribution where :

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 are made on behalf of the marketing authorization holder, cf. Section 23, paragraph 1. 4.

Self-Inspection

§ 34. 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.

$35. 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. Pharmacies and orderpots must also break medicinal products in accordance with the rules in the notice on the splitting of medicinal products for animals and the notification of dose dispensation of medicinal products.

§ 36. 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 6

Good distribution practices for dissemination

§ 37. It is the responsibility of a facilitator to carry out the dissemination in accordance with good distribution practice for intermediaries.

§ 38. If the medicinal product is disseminated through a wholesaler, the intermediary must verify that the supplier wholesaler complies with the principles and guidelines of good distribution practice. This includes checking whether the supplier wholesaler is the holder of a licence for wholesale negotiation.

Paragraph 2. If the medicinal product is medicated through the manufacturer or importer, the intermediary shall verify that the manufacturer or importer is authorised to manufacture or import medicinal products or intermediate products.

Paragraph 3. Where the medicinal product is disseminated through another means of preparation, the intermediary must verify that the intermediary concerned meets the requirements laid down for intermediaries.

Paragraph 4. The intermediary must verify that the consignee has a relevant permit.

Quality assurance system

§ 39. A pre-financing must establish and use an effective quality assurance system that actively involves the management and the staff of the affected departments in the establishment. The intermediary must provide written proof of the quality assurance system, including description of areas of responsibility, workflow and risk management measures related to the establishment.

Inbound Medicinal Products

§ 40. A means of intermediaries must ensure that the medicated medicinal products are subject to a permit for marketing in an EU or EEA country.

§ 41. A intermediaries must keep records of all access and outgoing medicinal products in the form of information relating to :

1) the date of the dissemination,

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

3) disseminated quantity,

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

5) the name and address of the supplier and the recipient,

Revocation

§ 42. An effective system shall have an effective system which ensures the implementation of a withdrawal from the market following orders from the Board of Health, or in cooperation with the manufacturer, the supplier of the medicinal product concerned or the holder of : the marketing authorization for the medicinal product concerned.

Deleting from the list of registered intermediaries

§ 43. If the Board of Health is deleting a means of resources from the list, according to section 41 c (2), 3, in the case of medicinal products, the Health Board shall inform the person concerned thereof.

Chapter 7

Inspection, forwarding of information, etc.

§ 44. 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 of good distribution practices. The content of these inspection reports shall be communicated to the wholesaler concerned or the means to store the report on the premises. Before the report is adopted, the Board of Health at the time of the inspection concerned shall be given the opportunity to make observations.

Paragraph 2. 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.

Paragraph 3. The Board of Health shall provide information on authorisations given in accordance with this publication in the EU database administered by the Agency on behalf of the European Union.

§ 45. No later than 90 days after inspection as referred to in Section 44, the Board of Health shall issue a certificate of good distribution practice to the wholesalator, if the conclusion of the inspection visit is that the person concerned complies with the principles and guidelines ; good distribution practices.

Paragraph 2. The Board of Health shall be left in the first 1 certificates shall be introduced in a Community database administered on behalf of the EU by the European Medicines Agency.

Paragraph 3. If the conclusion of an inspection referred to in paragraph 1 is carried out, Paragraph 1 is that the wholes-negotiator fails to comply with the principles and guidelines for good distribution practice shall be introduced in the information provided for in paragraph 1. 2 related to the Community database.

§ 46. The Board of Health shall have a monitoring system covering inspection visits at appropriate intervals, based on the risk of importers and distributors belonging to Denmark and an effective follow-up to that effect.

§ 47. 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.

§ 48. 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.

§ 49. 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.

$50. If a medicinal product in connection with a case of recall is suspected of posing a serious risk to public health, and first was identified in Denmark, the Board of Health must immediately ensure that a prompt warning is sent to everyone : The competent authorities of the EU/EEA countries and all relevant stakeholders in the chain of supply chain in Denmark.

Paragraph 2. In the case of medicinal products as referred to in paragraph 1. 1 may be presumed to be reached for patients, will issue the Health Service, or the wholesalers, within 24 hours a notice to the general public about the presumed quality deficiency or forgery, the possible risks and recommendations to patients.

§ 51. The Board of Health may dispense with one or more of the provisions of this notice, provided that such specific conditions are given.

Punishment and entry into force

§ 52. Unless higher penalties are imposed on other legislation, the penalty shall be penalized for the penalty which violates § 8, section 12, section 14-22, section 23, paragraph 1. Paragraph 1, section 24, paragraph 4. 1 and 3, § § 25-34, section 35, paragraph 1, section 36-42.

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

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

Paragraph 2. Publication no. 823 of 1. August 2012 on the distribution of medicinal products is deleted.

Paragraph 3. Persons and undertakings which are medicinal products and who began their business before 1. In January 2013, the Board of Health shall be registered at the latest by 1. March, 2013.

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.