Chapter 1	Objective and region
Chapter 2	Marketing Permission and other authorizations for sale and extradition
Chapter 3	Manufacture, importation, negotiation, dissemination, etc. of medicinal products and intermediate products ;
Chapter 3 a	Prohibition, warning, revocation, etc.
Chapter 3 b	Manufacture, import and distribution, etc. of active substances
Chapter 4	Quality of medicinal products
Chapter 5	Medicinal effects on medicinal products
Chapter 6	Labelling, apothecary reservations and delivery status
Chapter 7	Advertising, bonus, rebates, etc.
Chapter 8	Information on medicinal products
Chapter 9	Mean supplies
Chapter 10	Prices, sortiment, item numbers, and statistics
Chapter 11	Attempt
Chapter 12	Certain substances which may be used as medicinal products for animals
Chapter 13	Council and name, etc.
Chapter 14	Fees
Chapter 14 a	Kundstatement
Chapter 14 (b)	Appeal access
Chapter 15	Punishment, etc.
Chapter 16	Entry into force, alteration and transitional provisions

Publication of the law on medicinal products 1)

This shall be the subject of the law. 1180 of 12. In December 2005, on medicinal products with the amendments resulting from Article 81 of Law No 538 of eight. June 2006, section 1 of law no. 1557 of 20. December 2006, section 1 of law no. 534 of 17. June 2008, section 1 of law no. 464 of 18. May 2011, section 46 of the law. 593 of 14. June 2011, section 1 of law no. 605 by 18. June 2012, section 1 of law no. 1258 of 18. December 2012 and Section 1 of the Law No 63 of 29. January 2013.

Chapter 1

Objective and region

§ 1. The law's purpose is to ensure that citizens

1) has access to a high quality and effective medicinal product ;

2) has access to objective and adequate information on medicinal products ; and

3) are protected from misleading pharmaceutical advertising and other illegal marketing of medicinal products.

§ 2. For the purposes of this Act :

1) Medicinal Product : Any item that

a) is presented as a suitable means for the treatment or prevention of disease in humans or animals ; or

b) may be used in or given to humans or animals, either in order to restore, alter or influence physiological functions by exercising a pharmacological, immunological or metabolic effect or in order to provide a medical diagnosis.

2) Intermediate product : a mixture of active substances and formulants intended for further processing into a medicinal product.

3) Substances : Any substance or combination of substances intended to be used in the manufacture of a medicinal product and which, by entering production, becomes an active ingredient of the medicinal product to carry out a pharmacological, immunological or the metabolical effect of re-establishing, altering or influencing physiological functions, or to provide a medical diagnosis.

4) ' auxiliary material ` means any ingredient of a medicinal product other than the active substance and packaging materials.

§ 3. The law includes medicinal products for human beings and animals.

Paragraph 2. Provisions relating to medicinal products also include contraceptives, which are not covered by Article 2 (2). One or the law of medical equipment.

Paragraph 3. In addition, the law shall apply to the extent that the individual provisions apply to the following goods, which are not covered by Section 2. 1 :

1) Intermediate products are intended for further processing into a medicinal product.

2) Active substances and formulants.

3) Certain substances which may be used as medicinal products for animals.

Paragraph 4. The section 65 and 71 of the law also covers advertising for certain products other than medicinal products.

§ 4. The law shall not apply to food and food supplements, feedingstuffs, cosmetics, biocides, radionuclides in the form of closed sources, medical devices, unprocessed tissues and cells of human origin and blood cells, blood cells and plasma of human human plasma ; origin other than plasma used as raw material in the manufacture of medicinal products, cf. however, paragraph 1 2 and sections 65 and 71.

Paragraph 2. In cases where a product based on a total assessment of its characteristics may be subject to the definition of a medicinal product as well as the definition of an item in another area of legislation and there is doubt on which legislation the item is to be regulated ; After that, the Board of Health may decide that the product or group of goods in question is governed solely by that law ; after negotiating with the minister concerned, the Minister for Health and Prevention may lay down special rules for such goods ; or scrupulp groups.

§ 4 a. By way of derogation from paragraph 3, paragraph Paragraph 4 (1) and section 4 (4), 2, the law does not apply to advanced therapy medicinal products, which are manufactured in a hospital in Denmark specially adapted to a particular patient after the individual display of a doctor.

§ 5. More like specified goods or groups of goods covered by Section 2 (2). 1 may, in accordance with the rules of the health and prevention minister, be wholly or partially excluded from the law when deemed appropriate from their properties. The minister for health and prevention lays down special rules for such goods or groups of goods.

§ 6. The Minister for Health and Prevention may lay down rules that the law or parts of the law do not apply to medicinal products approved or are to be approved for the marketing of the European Union according to rules laid down by the European Union ; Community, and may lay down rules for such exceptions.

Chapter 2

Marketing Permission and other authorizations for sale and extradition

Examination of marketing authorization

§ 7. A medicinal product may only be negotiated or delivered here in the country where a marketing authorization has been issued either by the Board of Health pursuant to this law or by the European Commission pursuant to EU legal rules concerning the establishment of : Community procedures for the approval and surveillance of medicinal products for human and veterinary medicinal products, etc. (Community marketing authorisation), cf. however, paragraph 1 2, section 11, and 29-32.

Paragraph 2. A medicinal product may only be traded online to users in other EU/EEA countries when it is covered by a marketing authorisation referred to in paragraph 1. 1 shall be subject to a marketing authorization applicable to the country of destination in accordance with Article 6 (1). 1, in Directive 2001 /83/EC or Article 6 (1). 1, in Directive 2001 /82/EC.

§ 8. The Board of Health shall issue an application for marketing authorization to a medicinal product if the relationship between the benefits and risks of the medicinal product is favourable and, incidentally, there is no such reference, as mentioned in sections 12 and 13.

Paragraph 2. For the purpose of weighing the relationship between the benefits and risks of a medicinal product, the positive therapeutic effects of the medicinal product shall be evaluated against the risks associated with the quality, safety and efficuse of the medicinal product and the risks of undesirable impact on the environment, cf. however, section 12 (2). 2.

Paragraph 3. Where the application relates to a medicinal product for animals for use other than disease treatment or zootechnical use, the weighing referred to in paragraph 1 shall be taken. The benefits of animal health and welfare, as well as consumer safety, are particularly high in the benefits of animal health and welfare.

§ 9. The Board of Health may attach conditions to the marketing authorization in the context of its issue.

Paragraph 2. In the case of special circumstances, the Management Board may also establish conditions for a marketing authorisation following its issue.

Paragraph 3. The Minister for Health and Prevention shall lay down rules on the health management assessment of conditions as set out in accordance with paragraph 1. 1.

§ 10. For the purpose of issuing a marketing authorisation, the Board of Health shall accept a summary of the characteristics of the medicinal product (product summary).

§ 11. Regardless of the provision in section 7 (4). 1, do not require marketing authorization for the following medicinal products :

1) Medicinal products prepared in a pharmacy to the individual patient or to the individual animal by the prescription of a doctor or veterinary medicinal product (MTs).

2) Inatives and notinactivated immunological medicinal products for animals produced from pathogenic organisms and antigens extracted from an animal or a livestock unit and used in the same place for the treatment of this animal or animal hushushus;

3) Medicinal products for non-medial testing and clinical trials, cf. Chapter 11.

4) Photo medicines.

Proposal and modification, suspension and revocation of marketing authorization

§ 12. The Board of Health shall refuse to issue a marketing authorisation to a medicinal product if :

1) the relationship between benefits and risks is not favourable, cf. however, paragraph 1 2,

2) the therapeutic effect is not sufficiently demonstrated by the applicant for the marketing authorization ; or

3) the medicinal product does not have the qualitative or quantitative composition of the product.

Paragraph 2. For medicinal products for human beings, the risk of undesirable effects on the environment is not isolated in isolation of a marketing authorisation marketing authorisation.

§ 13. In addition to the cases referred to in section 12, the Board of Health shall issue a marketing authorisation to a medicinal product for animals if :

1) labelling or package leaflet is not in accordance with rules laid down in Article 57,

2) the specified withdrawal period is insufficient to ensure that food derived from the treated animal does not contain residues which may be at risk for the health of consumers, or the withdrawal period is insufficient ; well done,

3) the medicinal product will be put up for sale to a use prohibited under other Community legislation ;

4) Whereas it is necessary to ensure the protection of public health, consumers or animal health, as long as Community legislation is in the process of being prepared ; or

5) the medicinal product is intended for submission to one or more food-producing species, and the pharmacologically active substances contained in the medicinal product, are not listed in Annexes I, II or III to Regulation on a common procedure for the fixing of : maximum residue levels for veterinary medicinal products residues in foodstuffs of animal origin (medical residues).

Paragraph 2. Notwithstanding paragraph 1 1, no. 5, the Board of Health may lay down detailed rules on the granting of marketing authorisation to medicinal products intended for specified animals of the Hestaste.

§ 14. The Board of Health shall amend, suspend or revoke a marketing authorisation for a medicinal product, if it proves that :

1) the relationship between benefits and risks is not favourable ;

3) the medicinal product does not have the qualitative or quantitative composition of the product,

4) the essential information supplied by the applicant to support the application for the marketing authorization is incorrect or

5) own checks according to the rules laid down in section 39 b (b), One-point-three, has not been implemented.

Paragraph 2. The Board of Health may amend, suspend or revoke a marketing authorisation for a medicinal product, if :

1) holder of the marketing authorization shall not comply with the terms of the authorisation laid down in accordance with section 9 (3). 1,

2) labelling or package leaflet is not in accordance with rules laid down in section 57 or

3) the marketing authorization holder shall modify the product summary or the documents relating to the marketing authorization without the consent of the Board of Health, in accordance with the authorization for the Health Board. Section 26 (1). 1.

§ 15. In addition to the cases referred to in section 14, the Board of Health shall suspend or revoke a marketing authorisation for a medicinal product for human beings, in addition to the case of :

1) the marketing authorization holder has not taken account of new information on technical and scientific developments in accordance with section 21 ; or

2) the marketing authorization holder has not notified the Board of Health for new information on the relationship between the benefits and risks of the medicinal product in accordance with section 25 (5). 1.

Paragraph 2. The Board of Health may amend, suspend or revoke a marketing authorisation for a medicinal product for human beings,

1) the medicinal product is not produced in accordance with the description of the manufacturing method, as shown in the application for marketing authorization and subsequent amendments thereto ; or

2) the marketing authorization holder does not carry out checks in accordance with the control methods laid down in the application for the marketing authorization and subsequent amendments thereto.

§ 16. In addition to the cases referred to in section 14, the Board of Health shall suspend or revoke a marketing authorisation for a medicinal product for animals if :

1) the specified detention period is insufficient to ensure that food derived from the treated animal does not contain residues which may be a danger to the health of consumers ;

2) the medicinal product is or will be put up for sale to a use prohibited under other Community legislation, or

3) the marketing authorization holder shall not make the necessary steps taken in accordance with section 26 (3). 2.

Paragraph 2. The Board of Health may modify, suspend or revoke a marketing authorisation for a medicinal product for animals,

1) the marketing authorization holder has not taken account of new information on technical and scientific developments in accordance with section 21 ;

2) the marketing authorization holder has not notified the Board of Health for new information on the relationship between the benefits and risks of the medicinal product in accordance with section 25 (5). 1, or

3) Whereas it is necessary to ensure the protection of public health, consumers or animal health, as long as Community legislation in this field is in preparation.

§ 17. The Board of Health shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities of the other EU/EEA countries when rapid action is considered necessary as a result of the evaluation of information from pharmacovigilance, if :

1) The Board of Health is considering suspending or revoking a marketing authorisation for a medicinal product for human beings ;

2) The Board of Health is considering banning the provision of a medicinal product for human beings ;

3) The Board of Health is considering rejecting the renewal of a marketing authorisation for a medicinal product for human beings ;

4) The health management of the marketing authorization holder of a medicinal product for human rights shall be informed that the safety of the medicinal product has stopped the marketing of the medicinal product or has taken steps to renunciate himself ; the marketing authorization or intends to do so ; or

5) The Board of Health considers it necessary to have a new countersign, a reduction in the recommended dose or a reduction in the indications of a medicinal product for human beings.

Paragraph 2. A quick procedure for dealing with a medicinal product subject to paragraph 1 shall be subject to paragraph 1 shall be provided by the Board of Health, if the medicinal product is authorized only for negotiation or extradition here in the country. If the medicinal product is approved for negotiation or extradition in more than one EU/EEA country, the assessment of the medicinal product after a special European Union emergency procedure shall be treated.

Paragraph 3. The Minister for Health and Prevention may lay down detailed rules on the treatment of medicinal products under paragraph 1. TWO, TWO. Act.

Paragraph 4. If the Board of Health, with an immediate effect, is to suspend a marketing authorisation for a medicinal product for human health, cf. Section 14, paragraph 14. 1, as a result of the evaluation of information from pharmacovigilance, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities at the latest, by the European Medicines Agency, the European Commission and the pharmaceutical authorities in the other EU/EEA countries.

§ 17 a. The Board of Health shall inform the European Medicines Agency if the Management Board initis a case of suspension or withdrawal of a marketing authorisation for a medicinal product for human beings.

Paragraph 2. The Board of Health shall inform the European Medicines Agency, the pharmaceutical authorities of the other EU/EEA countries and the marketing authorization holder if any new or modified risks or alterations in the relationship between benefits and risks are shown ; Medium.

§ 17 b. The Board of Health shall inform the European Medicines Agency if the Management Board initials a case of suspension or withdrawal of a marketing authorisation to a medicinal product for animals.

Paragraph 2. If the Board of Health, with an immediate effect, shall suspend a marketing authorisation to a medicinal product for animals to protect human and animal health, cf. Section 14, paragraph 14. 1, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities at the latest, by the European Medicines Agency, the Commission and the pharmaceutical authorities in the other EU/EEA countries.

Requirements for marketing authorisations

§ 18. The applicant and the holder of a marketing authorisation shall be established in an EU/EEA country. The holder may appoint a representative.

§ 19. The holder of a marketing authorisation shall not be affected by the fact that a marketing authorisation has been issued.

Paragraph 2. The holder of a marketing authorisation shall be responsible for the marketing of the medicinal product. Epipeting of a representative, cf. Section 18 does not release the holder of the marketing authorization for responsibility.

20. The applicant for or holder of a marketing authorisation shall ensure that documents and data submitted to the Board of Health are complete and fair.

§ 21. The holder of a marketing authorisation shall take account of technical and scientific developments and make the changes necessary for the preparation of the medicinal product and to be inspected according to generally accepted scientific methods.

Paragraph 2. The holder of a marketing authorisation for a medicinal product for human beings must update the information in the product's product summary, package leaflet and labelling with the current knowledge, including conclusions of assessments and recommendations published on ; The web portal of the European Medicines Agency on Medicinal Products.

§ 22. The holder of a marketing authorisation shall shortly inform the Board of Health of when, in actual fact, the marketing of the medicinal product is started and when the marketing of the marketing is temporarily or permanently discontinued.

Paragraph 2. Reporting to Pharmaceutical Prices, cf. section 82, and notification by the rules laid down in accordance with Article 78 shall be considered as a notification under paragraph 1. 1.

-23. The holder of a marketing authorisation shall inform the Board of Health of the cause in cases where the holder decides on the withdrawal of a marketing authorisation and withdrawal of repositories, as well as temporary or permanent ; the termination of the placing on the market where this is justified in the quality, safety or effinature of the medicinal product.

§ 24. The holder of a marketing authorisation shall immediately inform the Board of Health if there are errors in the production of a medicinal product which may have an impact on the quality, safety and effigory of the medicinal product.

§ 25. The holder of a marketing authorisation for a medicinal product shall immediately inform the Board of Health of any material new information relating to the relationship between the benefits and risks of the medicinal product, which shall not be informed of the steering system in accordance with the procedure for : approval of changes to marketing authorisations or in the form of periodic security updates ; If information is concerned with a medicinal product for human beings, the information on the part of the European Medicines Agency must also be subject to information.

Paragraph 2. The Board of Health may, at any time, invite the holder of a marketing authorisation to demonstrate that the ratio between benefits and risks remains favourable.

Paragraph 3. The Board of Health shall check that the requirement referred to in paragraph One is being respected, and the representatives of the board have to give due legitimacy and without a court order of access to businesses in order to carry out this control.

SECTION 26. The holder of a marketing authorisation issued by the Board of Health shall apply for the authorization of the Administrative Board on any modification to the product summary and the documents relating to the marketing authorization (variations application).

Paragraph 2. In the case of changes to the Annexes to the Medical Redef Regulation, the marketing authorization holder shall, within 60 days of its publication, apply the Board of Health to make the necessary changes or ; even withdraw the marketing authorization.

Duration, Extension and Wastes of Marketing Permissions

§ 27. A marketing authorisation for a medicinal product shall be valid for 5 years, cf. however, paragraph 1 2 and section 14-16.

Paragraph 2. The Board of Health may extend the marketing authorization if the relationship between benefits and risks remains favourable. A marketing authorization which has been extended has a limited period of validity, cf. however, paragraph 1 3 and section 14-16.

Paragraph 3. The Board of Health may decide that the marketing authorization may only be extended for a period of five years if the relationship between the benefits and risks of the medicinal product is attributable to it, including as a result of the evaluation of information from pharmacovigilance.

Paragraph 4. An application for the extension of a marketing authorisation to a medicinal product for human beings must be submitted to the Health Care Board of the marketing authorization holder no later than nine months before the expiry of the authorisation.

Paragraph 5. An application for the extension of a marketing authorisation to a medicinal product for animals shall be submitted to the Health Care Management holder of the marketing authorization holder no later than six months before the expiry of the authorisation.

§ 28. A marketing authorisation shall lapses if the permit has not been used in 3 consecuction years.

Paragraph 2. The health department may derogate from the provision of paragraph 1 in exceptional circumstances and in the interests of human and animal health. 1.

Other authorisations for the sale or supply of medicinal products

§ 29. The Board of Health may, upon application in specific cases, permit the sale or extradition in limited quantities of medicinal products not subject to a marketing authorisation or not placed on the market in Denmark.

Paragraph 2. The Board of Health may establish conditions for the delivery permit and can revoke a permit if these conditions are not met or there are serious problems with the quality, safety or efficability of the medicinal product, including serious adverse reactions.

Paragraph 3. The Board of Health may lay down rules on the distribution of medicinal products subject to authorisation under paragraph 1. 1.

-$30. The State Serum Institute and Veterinary Institute at Denmark ' s Technical University may, at the request of specific cases and in limited quantities, to sell or extradite sera, vaccines, specific immunological glodents and other immunological test preparations which do not ; are subject to a marketing authorisation. The Board of Health shall be informed of each sale or delivery.

§ 31. The Board of Health may, where necessary, in accordance with the rules laid down by the Minister for Health and Prevention of Prevention and Marketing of medicinal products not covered by a marketing authorisation, in accordance with the rules laid down by the Health and Prevention of Medicinal Products, in Denmark. The Minister may also lay down rules for the amendment, suspension and revocation of such authorisations.

Paragraph 2. The Board of Health shall inform the European Commission of the authorisations 1.

§ 32. If there is any suspicion or confirmation of the spread of pathogenic agents, toxins, chemical agents or nuclear radiation, the Board of Health may temporarily authorize the provisioning of a medicinal product, irrespective of the fact that the medicinal product is not covered by a product ; marketing authorization.

Paragraph 2. The Minister for Health and Prevention may lay down rules to permit holders of marketing authorisations, promoters and health professionals in the situations referred to in paragraph 1. 1 shall not be liable for the consequences resulting from the use of :

1) a medicinal product outside its approved indications or

2) a medicinal product which is not subject to a marketing authorisation.

Paragraph 3. Rules laid down in accordance with paragraph 1. 2 is not exempt from liability under the responsibility of product liability.

Health care processing of cases of marketing authorisations and other authorisations for the sale and supply of medicinal products

§ 33. In this country, the Board of Health shall attend to the tasks relating to the processing of applications for marketing authorisation following the reciprocal recognition procedure and the decentralisation procedure arising from the rules of the European Parliament and Council Directives on the establishment of a Community code on medicinal products for human use and veterinary medicinal products.

§ 34. The Minister for Health and Prevention shall lay down rules on :

1) The information to accompany an application for the granting or extension of a marketing authorisation, including information on the quality, safety and efficuse of the medicinal product and its possible impact on the environment, and the application for the issue of the authorization ; or an extension of a marketing authorization shall, in any case, satisfy.

2) Special conditions for granting marketing authorization to

a) Medicinal products,

b) vitamin and minerals, and

c) homeopathic medicinal products.

3) Special conditions for the registration of homeopathic medicinal products and traditional herbal medicinal products.

4) What special conditions have to be met in order that a radioactive medicinal product can obtain a marketing authorisation.

5) The health management processing of cases of marketing authorisations and information to the European Medicines Agency on the conditions laid down in the case of the management of the management board.

6) The processing of the cases and cases referred to in Section 33 of the Community marketing authorisations referred to in Section 33.

$35. In the case of the treatment of applications for marketing authorization and issue, extension, modification, suspension or revocation of a marketing authorization, the Board of Health may invite the applicant to, or the holder of a marketing authorisation to supply necessary information, including written material, samples of the medicinal product, including its packaging, and samples of intermediate products, active substances and formulants.

§ 36. The Board of Health may lay down detailed rules on the information to be provided for in applications and under-directions in accordance with sections 22-27, 29 and 30, and the time limits for submission of such information.

§ 37. The Board of Health may lay down requirements for the submission of applications and information under the provisions of this chapter, including that submission must be made electronically.

§ 38. The Board of Health shall keep a register of the medicinal products approved and approved by a marketing authorisation in accordance with the provisions of this Chapter.

Chapter 3

Manufacture, importation, negotiation, dissemination, etc. of medicinal products and intermediate products ;

§ 38 a. No production, import, export, storage, negotiation, dissemination or the supply of counterfeit medicinal products shall be prohibited. however, paragraph 1 2.

Paragraph 2. The one authorized in accordance with section 7 (2). 1, in limited quantities, may carry out and store medicinal products purchased in order to examine the presence of counterfeit medicines among the medicinal products subject to the authorisation.

§ 39. Manufacture, import, export, storage, distribution, distribution, distribution, discarding, splitting and packaging of medicinal products may only be authorised by the Board of Health.

Paragraph 2. Manufacture, importation, export, storage, distribution and distribution of intermediate products intended for subsequent processing to a medicinal product may only be carried out with the permission of the Board of Health.

Paragraph 3. Rule of paragraph (1) Paragraph 1 shall not apply to :

1) The distribution, fragmentation and distribution of medicinal products to be used in the treatment shall be broken down and the delivery of medicinal products.

2) The distribution, splitting and distribution of medicinal products for use in practice shall be divided into the distribution of the livestock and dentists.

3) Imports of private individuals and exports to their own consumption of medicinal products for human beings.

4) The distribution, fragmentation and distribution of medicinal products to humans for use on board and the import of such medicinal products at the port of foreign harbour shall be broken down and redistribute.

5) Imports, export and storage of medicinal products as referred to in section 38 (a) (a), 2.

Paragraph 4. The Board of Health may lay down rules on the handling of medicinal products referred to in paragraph 1. 3, no. 1-5.

§ 39 a. The Minister for Health and Prevention shall lay down rules on :

1) The information to accompany an application for authorization after paragraph 39 (3). 1 and 2, and the conditions for obtaining a permit.

2) Requirements for the requirements of no. 1 mentioned applications, including that the application shall be made electronically.

3) The health management examination of applications for authorization after paragraph 39 (5). One and two.

4) The disclosure of information on authorisations issued in accordance with section 39 (2) of the health management system shall be the case 1 and 2, amending, suspension and revocation of such authorisations and of checking activities carried out in accordance with section 44 to the European Medicines Agency, the European Commission and the pharmaceutical authorities of other EU/EEA countries.

Paragraph 2. In order to ensure compliance with the conditions laid down in paragraph 1. 1, no. 1, the Board of Health may attach conditions to the permit, including the time limit.

§ 39 b. The Board of Health shall provide for :

1) Requirements for technical management, professional knowledge, information and operation of the one authorized by Article 39 (3). One and two.

2) Requirements for the active substances and formulants, as authorised by Article 39 (2), 1 or 2 shall apply in the manufacture of medicinal products or intermediate products.

3) Actions like the one that has permission under Section 39 (2). 1 or 2, for the manufacture of medicinal products or intermediate products, to ensure that the active substances and formulants used in the manufacture of medicinal products or intermediate products meet the requirements laid down in paragraph 1. 2.

4) Shipping of medicinal products to users for the one authorized by Article 39 (3). 1, including rules concerning the obligation to provide information to the medicinal product on medicinal products.

§ 40. The Board of Health may amend, suspend or revoke a permit in accordance with section 39 (5). 1 and 2, if the conditions of the permit or terms associated with this are not met or if the holder of the authorization has been grossly or repeatedly infringed rules issued in accordance with section 39 b, nr. 1 3, or § 40 b or refuse to contribute to the control of health management after paragraph 44.

Treatment of medicinal products for production animals

§ 40 a. The one authorized in accordance with paragraph 39 (2). The first is the right to negotiate and to hand over all prescription-only medicines intended for production animals.

Paragraph 2. The one authorized in accordance with paragraph 39 (2). 1, for the distribution of medicinal products to the users of production animals, do not negotiate or extradict products other than medicinal products to production animals and only in exceptional cases and with the minister of health and prevention, to carry out other tasks ; than those set out in paragraph 1. 1 and by rules issued in accordance with section 40 b.

Paragraph 3. The one authorized in accordance with paragraph 39 (2). Paragraph 1, for the use of veterinary medicinal products for production animals, must not, without the authorisation of the Health Management Board, operate or be linked to another undertaking which is entitled to Article 39 (3). 1 or 2, to other than bargaining for the users of medicinal products for production.

§ 40 b. The Minister for Health and Prevention shall lay down detailed rules on the special, supplementary obligations incumbliging on the one authorized by the third paragraph of paragraph 39 ; 1 for the distribution of medicinal products to the animals for production animals, including rules concerning :

1) Disposal, negotiation and delivery of prescription-only medicinal products for users.

2) Information and guidance on users.

3) Service targets.

4) Collection of medical residue.

5) Compliance with risk management programs, cf. § 62.

6) The closure of accounts.

Online negotiation of medicinal products

§ 41. The one authorized in accordance with paragraph 39 (2). 1 and which, within the framework of its authorisation, wish to negotiate medicinal products online for users, shall notify the Board of Health before or at the beginning of this debate at the beginning of this debate.

Paragraph 2. The Board of Health shall, and shall publish on its website, a list of resellers who have notified the notification of paragraph 1. 1 and apothecaries that have notified the following section of section 43 (a), 1, in the case of apothecary.

Paragraph 3. The Board of Health shall inform its website of the online negotiation of medicinal products, including the risks associated with the purchase of medicinal products from Internet domains which are not subject to regulatory control. The Minister for Health and Prevention shall lay down detailed rules on this matter.

§ 41 a. The Board of Health shall lay down rules on the special, supplementary obligations incumblime to the one who has issued a notification in accordance with section 41 (1). 1, including rules concerning :

1) The information to accompany the communication and the obligation to notify the Board of Health to inform the Board of Health of any changes to this information.

2) Requirements for the message, including that the message is to be sent electronically.

3) Requirements for the Internet domain from which the medicinal products are offered for sale, including rules on the information to be included in the domain, the requirements of its technical reporting and the obligation to use a pan-European security logo.

Dissemination of medicinal products

§ 41 b. The marketing of medicinal products is only permitted for the person who has registered the Board of Health and which is listed in the list referred to in paragraph 1. 2.

Paragraph 2. The Board of Health shall, and shall publish on its website, a list of intermediaries registered in accordance with paragraph 1. 1.

Paragraph 3. The Board of Health may delete an amount of money from the list referred to in paragraph 1. 2 if the retailer has been brutally or repeatedly violating rules issued in accordance with section 41 or refuses to contribute to the control of the Board of Health after Section 44.

§ 41 c. The Minister for Health and Prevention shall lay down rules on :

1) The information to accompany a registration notification in accordance with section 41 (b) (b). 1, and the obligation to notify the Board of Health of any changes to this information.

2) Requirements for the requirements of section 41 (b), 1, the notifications referred to, including notification of the notification, shall be carried out electronically.

3) The health management treatment of notifications after paragraph 41 b (1) (b) ; 1.

§ 41 d. The Board of Health shall lay down rules relating to the requirements of intermediaries of medicinal products, including technical management, professional knowledge, information and operation of the undertaking. The Management Board shall also lay down rules on the types of medicinal products to be communicated by the person registered after paragraph 41 b (b). 1.

Signature of falsified medicinal products and intermediate products

§ 42. The one authorized in accordance with paragraph 39 (2). 1 or 2, for the manufacture of medicinal products or intermediate products, inform the Health and marketing authorization holder of the medicinal product concerned without delay and the marketing authorization holder for the medicinal product concerned, provided that it is known that a medicinal product or intermediate product, which is available for use, must be notified ; this maker is or may have been falsified.

Paragraph 2. The one authorized in accordance with paragraph 39 (2). 1, for the negotiation of medicinal products, and the one registered after paragraph 41 b (b). 1, shall notify the Board of Health and, where appropriate, the marketing authorization holder for the medicinal product concerned, if it receives or receives an offer to purchase medicinal products which are or may be falsified.

Paragraph 3. The Board of Health may lay down rules on the content and requirements of the requirements referred to in paragraph 1. 1 and 2 of the said information, including that the notification must be made electronically.

Paragraph 4. The Board of Health may lay down rules on the holder of a permit in accordance with section 7 (2). 1, inform the management board of the findings of falsified medicinal products.

§ 42 a. The Board of Health may, by findings or suspicions of the discovery of falsified medicinal products or intermediates, all information relating thereto to the holder of the marketing authorization for or the manufacturer of the medicinal product concerned or the intermediate product.

Information on non-application for marketing authorization

§ 43. The one authorized in accordance with paragraph 39 (2). 1, for the manufacture or export of medicinal products, shall, at the request of the Board of Health, inform the Board of Health of the reason for not applying for a marketing authorisation to one or more of the medicinal products in Denmark.

Records

§ 43 a. The one authorized in accordance with paragraph 39 (2). 1 and apothecaries shall keep records of the handling and other medicinal products. The Board of Health shall lay down rules on this

Assignment

§ 43 (b). The one authorized in accordance with section 7 (2). Paragraph 1, or Section 39 (2). 1, notify the Board of Health of doctors, dentists and pharmacists who are associated with the establishment. This does not, however, apply to public hospitals.

Paragraph 2. The minister of health and prevention shall lay down rules on the obligation to notify the person, including the rules on notification of notification of electronic means.

Name of administration

§ 44. The Board of Health controls compliance with the requirements laid down in this Act and in rules issued under the Act of Medicinal Products and Intermediates, and to the one handling medicinal products or intermediate products.

Paragraph 2. In order to carry out their control tasks in accordance with paragraph 1, 1 or in order to satisfy a request from another EU/EEA country, the European Commission or the European Medicines Agency, the representatives of the Health Management Board shall have the appropriate credentials and without a court order of access to :

1) Companies which have a permit in accordance with section 7 (2). 1.

2) Companies that have a permit in section 39 (s). One or two.

3) Companies registered after paragraph 41 b (s). 1.

4) Companies registered after paragraph 50 (a) (a) 1.

5) Undertakings producing or introducing formulants.

Paragraph 3. The control tasks of the health management service shall be carried out in cooperation with the European Medicines Agency. The Board of Health shall exchange information relating to this cooperation with the European Medicines Agency on Planned and superviable inspections.

Paragraph 4. The Board of Health shall draw up a report on any control visits carried out in accordance with paragraph 1. 2.

Paragraph 5. The Board of Health may, irrespective of the provision in paragraph 2, no. 5, take inspection visits to an establishment producing or introducing aids, if so requested.

§ 44 a. In order to carry out its control tasks in accordance with section 44 (2), 1, the Board of Health shall charge free of charge against receipt of the payment or call for extraditing samples of medicinal products and products which are grounds for the asument of medicinal products, including packaging and package leaflets, intermediate products, active substances and formulants. The Management Board may also require all information and materials necessary for the control company.

Section 44 b. The Board of Health may give the holder of a permit in accordance with section 39 (4). 1 or 2, and the one registered after paragraph 41 b (s). 1, the purpose of changing the task of the operation, organisation, construction or operation, and establishing a deadline for the implementation of the amendments to ensure compliance with rules issued under section 39 b, section 40 b, section 41 a, nr. 3, or § 41 d.

§ 44 c. The Board of Health may impound medicinal products and products which are grounds for demode of medicinal products to be traded to users in breach of section 7 (3). Paragraph 1, section 39, paragraph. Paragraph 1, or § 60 (2). 1. The Board of Health may also impound medicinal products and products which are grounds for the consumption of medicinal products which, contrary to the rules on the importation of private individuals, are to be imported from countries that are not a member ; by the EU or the EEA.

Paragraph 2. Poscation carried out pursuant to paragraph 1. 1 shall be carried out in accordance with Chapter 74 of the Court of Justice Chapter 74 of the seizure.

§ 44 d. The representatives of the Food Board shall have appropriate credentials and without a court order of access to establishments authorised to negotiate feed medicinal products for animals or fish after Article 39 (3). 1. The representatives of the Food Authority may require a presentation and a copy of the order of the order of animal feed prescribed by veterinary medicinal products.

§ 45. The Minister for Health and Prevention, in accordance with the minister concerned, may lay down rules that representatives of authorities belonging to the relevant ministers are able to carry out checks on behalf of the Board of Health and the exercise of their rights, powers of section 44 (a) and (44 c) of this law. ONE, ONE. pkt. shall be placed on the Board of Health, in order to ensure the lawful distribution of medicinal products.

Chapter 3 a

Prohibition, warning, revocation, etc.

§ 46. The Board of Health may prohibit the negotiation and delivery of a medicinal product and may claim that withdrawal from the market should be withdrawn ;

1) the relationship between the benefits and risks of the medicinal product is not favourable ;

2) the therapeutic effect of the medicinal product is lacking ;

3) the medicinal product does not have the qualitative or quantitative composition of the product,

4) the self-monitoring of the medicinal product, its intermediate products, active substances or formulants, according to rules laid down in accordance with section 39 b (b), 1 3, has not taken place or any other requirement related to the issuing of the authorization after paragraph 39 (3). 1 or 2 has not been met ;

5) the medicinal product derives from a company which does not have the consent of the Board of Health pursuant to Article 39 (3). 1 or 2 or not contributing to the control of the Board of Health after paragraph 44,

6) the medicinal product has not been produced in accordance with the description of the manufacturing method, which is stated in the marketing authorization and subsequent amendments thereto, or if checks are not carried out in accordance with the control methods laid down ; of the application for the marketing authorization and subsequent amendments thereto,

7) there is a reasoned request for the medicinal product to constitute a serious health risk ;

8) the marketing authorization of the medicinal product shall be suspended or revoked pursuant to section 14 to 16 ; or

9) a recommendation to comply with the applicable rules on the labelling of medicinal products has been unsuccessful.

Paragraph 2. The Board of Health shall forthwith inform the European Medicines Agency on Decisions pursuant to paragraph 1. 1 and of the reasons for this.

Paragraph 3. In exceptional circumstances, in a transitional period, the Board of Health may authorize the extradition of a medicinal product after 29 to patients in treatment with the medicinal product concerned, even though the medicinal product is subject to a prohibition or an injunction in accordance with paragraph 1. 1.

Paragraph 4. The Minister for Health and Prevention may lay down rules on the processing of the health management of cases subject to paragraph 1. 1.

§ 46 a. The Board of Health may require the negotiation and delivery of a medicinal product not subject to a marketing authorisation in accordance with the requirements of the marketing authorization. section 7, or any other permit for the sale or the supply of medicinal products, cf. Section 29-32, must be terminated and may claim that it is withdrawn from the market.

Prohibition of manufacture and importation

§ 47. The Board of Health may prohibit the manufacture of a medicinal product or imports thereof from a third country if a company authorised in accordance with paragraph 39 (5). Paragraph 1 violates the rules governing the production and importation of medicinal products in accordance with section 39 b, no. 1-3.

Monitoring and warning

§ 47 a. The Board of Health shall set up a system for preventing the risk of medicinal products which may constitute a health hazard when the users are present. The Minister for Health and Prevention shall lay down detailed rules on this matter.

Section 47 b. Evaluating Health Services, that a medicinal product being negotiated or delivered in this country is a serious health hazard, the Management Board shall immediately send an emergency alert to the competent authorities of other EU/EEA countries and all relevant actors in the supply chain in this country, according to rules laid down by the Minister for Health and Prevention. If the Board of Health assesses that such a medicinal product may have been available to users, the Management Board shall immediately send out a public warning to the use of the medicinal product.

Importation of feed medicinal products

§ 48. The Board of Health may lay down rules governing the importation of feed medicinal products derived from premixtures authorised in another EU/EEA country, the premixture of which has been a quantitative and qualitative equivalent to one of the FDA approved premixture.

Healthcare workers ' access to medicinal products

§ 49. Health professionals and other staff, including ambulance drivers established or employed in another EU/EEA country and which are requested for assistance to accidents and disasters in this country in accordance with bilateral agreements with neighbouring countries or in pursuance of a Nordic Health Emergency Agreement may, in limited extent, bring medicinal products from the home Member State to use in the premedial action. Such medicinal products may be brought into question, irrespective of the fact that a medicinal product is not subject to a marketing authorisation in Denmark when the medicinal product is approved in the country in which health care personnel and others are established or employed.

$50. A veterinarian established in another EU/EEA country may, by rules laid down by the Board of Health for limited use of medicinal products for the use of animals in this country, subject to rules laid down by the Board of Health in the limited amount of the animal health. Such medicinal products may be brought into the market, irrespective of the fact that the medicinal product is not subject to a marketing authorisation in Denmark.

Paragraph 2. A medicinal product to be brought in accordance with paragraph 1. Paragraph 1 shall be approved in the country in which the veterinarian is established and the composition of its composition shall be qualitatively and quantitatively equivalent to one of the Board of Health approved medicinal products.

Paragraph 3. Notwithstanding paragraph 1 1 and 2 sera and vaccines for animals must not be brought into the coasts.

Chapter 3 b

Manufacture, import and distribution, etc. of active substances

§ 50 a. Manufacture, importation and distribution of active substances which are intended to be used in the manufacture of medicinal products for human beings and which are subject to a marketing authorisation shall be permitted only for the person charged by his undertaking ; The Board of Health, which is listed in the list referred to in paragraph 1, shall be : 2.

Paragraph 2. The Board of Health shall, and shall publish on its website, a list of the manufacturer, importers and distributors registered in accordance with paragraph 1. 1.

Paragraph 3. The Board of Health may delete a company from the list referred to in paragraph 1. 2, if the grossly or repeatedly violates rules issued after § 50 c or refuses to contribute to the control of the Board of Health after Section 50 e.

§ 50 b. The Minister for Health and Prevention shall lay down rules on :

1) The information to accompany a registration notification in accordance with section 50 (a) (a). 1, and the obligation to notify the Board of Health of any changes to this information.

2) When the production, import and distribution of the goods and distribution may be initiated after notification has been filed.

3) Requirements for the requirements of no. 1 the notifications referred to, including the time limits for notification and notification to be made by electronic means.

4) The health management treatment of those referred to in paragraph 1. 1 the notifications referred to, including laying down, of any visits to the establishment.

5) The disclosure of information by the Board of Health, pursuant to rules, 1 shall accompany a registration notification in accordance with section 50 (a) (a), 1, to the European Medicines Agency.

§ 50 c. The Board of Health shall lay down rules governing the technical management, technical knowledge, the establishment and operation of establishments registered in accordance with section 50 (a) (1). 1, including rules laying down the conditions for the lawful introduction of active substances in the form of such active substances.

1) requirements for the manufacture of the substances in the exporting country ; and

2) requirements for the control and enforcement of good manufacturing practices for active substances and procedures in the case of non-compliance with good manufacturing practice, unless the export country is listed on the list referred to in Article 1 ; 111 b of Directive 2001 /83/EC.

Signature of falsified active substances

§ 50 d. The one registered after Article 50 (a) (1). 1 and the one authorized in accordance with section 39 (3). 1 or 2 for the manufacture of medicinal products or intermediate products, shall inform the Health Services without delay if they receive or receive an offer to buy active substances which are or may be falsified.

Name of administration

$50 e. The Board of Health shall check compliance with requirements laid down in this Chapter and in accordance with Article 50 (c).

Paragraph 2. In order to carry out their control tasks in accordance with paragraph 1, 1 or in order to satisfy a request from another EU/EEA country, the European Commission or the European Medicines Agency, the representatives of the Health Management Board shall have the appropriate credentials and without a court order of access to establishments registered, after paragraph 50 (a) (a), 1.

Paragraph 3. The Board of Health shall draw up a report on any control visits carried out in accordance with paragraph 1. 2.

§ 50 f. In order to carry out its control tasks in accordance with section 50 e (2), 1, the Board of Health shall charge free of charge against receipt of the receipt or demand extraditing samples of active substances. The Management Board may also require all information and materials necessary for the control company.

§ 50 g. The Board of Health may provide a business registered in accordance with section 50 (a) (a). 1, the purpose of which is to amend the taking of tasks, organisation, business or operation and to set a time limit for the implementation of the amendments to ensure compliance with rules issued under § 50 c. ` ;

Chapter 4

Quality of medicinal products

§ 51. A medicinal product, including its packaging, as well as intermediate products, active substances and formulants, must be of satisfactory quality.

Paragraph 2. Documentation for the definition of quality must include information on :

1) qualitative and quantitative constituents of the medicinal product,

2) the method of manufacture,

3) control methods with associated acceptcriteria (specifications) and

4) shelf life.

Paragraph 3. The people in paragraph 3. 2, no. The methods referred to in paragraph 2 and 3 shall be described in such detail as to be repeated in monitoring analyses carried out on the grounds for the Health Board.

§ 52. The Board of Health may lay down rules on the quality of medicinal products, including the quality of the packaging of medicinal products, and the quality of intermediate products, active substances and formulants. The Board of Health may lay down such requirements for quality in the form of standards in a pharmacopoeia. Equine.

Chapter 5

Medicinal effects on medicinal products

§ 53. The holder of a marketing authorisation for a medicinal product shall :

1) use a pharmacovigilance system to monitor the safety of the medicinal product, assess the possibility of risk inimmation and, if necessary, take appropriate measures,

2) conduct a detailed description of the pharmacovigilance system and, on request, make a copy of the description available to the Health Services, cf. however, paragraph 1 2,

3) keep records of suspected adverse reactions,

4) make the records available to the Board of Health,

5) report information on suspected adverse reactions to the Health Services or the European Medicines Agency,

6) prepare and submit periodic security updates to the Health Services ; and

7) have a court of experts in the field of pharmacovigilance residing in the European Union.

Paragraph 2. Paragraph 1, no. Two, do not apply to medicines for animals.

Paragraph 3. In the case of pharmacovigilance, the Board of Health may require the marketing authorization holder to designate a medicinal product to designate a contact person in Denmark for the person referred to in paragraph 1. 1, no. Seven, referred to experts.

Paragraph 4. The minister of health and prevention shall lay down rules on the rules laid down in paragraph 1. 1 Obligations of the marketing authorization holder, including concerning the reporting of suspected adverse reactions, in Denmark or a country outside the EU and the EEA, and the professional knowledge, business area and contact of the person concerned ; experts in the field of pharmacovigilance.

Paragraph 5. The Board of Health shall check that the requirements of paragraph 1 are Paragraph 1 and the rules laid down in accordance with paragraph 1 shall apply. Four is respected. In addition, the Board of Health controls compliance with the requirements for pharmacovigilance in EU legislation laying down Community procedures for the authorisation and surveillance of medicinal products for human and veterinary medicinal products, etc.

Paragraph 6. The representatives of the Board of Health shall have the right and without a court order of access to undertakings with a view to implementing it in paragraph 1. 5 mentioned checks. The Board of Health may invite undertakings to supply all information, including written material, necessary for the control establishment.

Paragraph 7. The Board of Health shall inform the European Medicines Agency, the European Commission, the pharmaceutical authorities of the other EU/EEA countries and the marketing authorization holder, if the management board comes to conclude that the holder of the holder of the authorization is concluded ; the marketing authorization does not follow the pharmacovigilance system specified in the description of the system, cf. paragraph 1, no. 2.

§ 54. The holder of a marketing authorisation for a medicinal product for human beings shall not without prior or, at the same time, notification to the Board of Health, the European Medicines Agency and the Commission to publish information on matters relating to : the security of the medicinal product based on pharmacovigilance.

Paragraph 2. The holder of a marketing authorisation for a medicinal product for animals shall not, without prior or at the same time, inform the Board of Health Information on the safety of the medicinal product based on pharmacovigilance.

Paragraph 3. Information referred to in paragraph 1 1 and 2 shall be presented in an objective and not misleading manner.

§ 54 a. The Board of Health may require the marketing authorization holder to publish to a medicinal product publishes or to a specific range of health workers or hospitals to provide information on the medicinal product which serves patient safety ; purpose, including information about suspected side effects.

Paragraph 2. The Board of Health may make requirements and content of the management referred to in paragraph 1. 1 mentioned information. The Board of Health may also set a time limit for publication or dispatch of the information.

§ 55. The minister for health and prevention lays down rules on health professionals to report information on suspected adverse reactions, including information from journals and autopsy declarations, to the Board of Health and Health.

Paragraph 2. The minister for health and prevention lays down rules on patients, relatives and animal owners ' access to reporting information about suspected side effects directly to the Board of Health.

§ 56. The Board of Health shall use a pharmacovigilance system to monitor the safety of the medicinal products and shall keep a register of adverse reactions. The Minister for Health and Prevention shall lay down detailed rules on the processing of the health management of the reported information and the treatment of periodic security updates.

Paragraph 2. The Board of Health may provide information on the reporting of adverse reactions to the European Medicines Agency, the European Commission, the pharmaceutical sector in the other EU/EEA countries, the patient delivery and marketing authorization holder. The Minister for Health and Prevention shall lay down detailed rules on this matter.

§ 56 a. The Minister for Health and Prevention may lay down rules on the requirements for reporting and periodic safety updates drawn up by holders of marketing authorisations after this chapter, including that it should be made electronically.

Chapter 6

Labelling, apothecary reservations and delivery status

§ 57. The Board of Health may lay down rules on and make demands for medicinal products ' s package leaflet, labelling, packaging and packaging. Such requirements may be made to the holder of the marketing authorization and other persons or undertakings which bring a medicinal product to the market.

§ 58. A medicinal product which is subject to a marketing authorisation issued by the Board of Health must be negotiated and provided under a name approved by the Board of Health at the time of a health care agency.

Paragraph 2. The name must be

1) a distinguished name, which must not be confused with the common name,

2) a common name in the context of a trade mark or the name of the marketing authorization holder ; or

3) a scientific designation for a trade mark or the name of the marketing authorization holder.

Paragraph 3. The name must not be deceptive in terms of the composition of the product, its effects or its properties, and must not be suitable for an exchange of confusion with other medicinal products.

Paragraph 4. The Minister for Health and Prevention may lay down rules on the naming of parallelimported medicinal products.

$59. Anyone who brings a medicinal product to the market in Denmark shall submit the package leaflet to the Ministry of Health, at any time.

Paragraph 2. The Board of Health may lay down deadlines and requirements for the submission of leaflets under paragraph 1. 1, including submission of electronic means.

§ 60. Treatment of medicinal products to users must only be carried out through pharmacies (apothecary reservations), unless otherwise specified by law or by the minister for health and prevention, cf. however, paragraph 1 Two and three.

Paragraph 2. The Board of Health may, when it is considered in health terms, that a non-prescription medicinal product, including specific packaging sizes, medicinal products or strengths of the medicinal product, can be negotiated to the users outside the pharmacies. The Board of Health may lay down restrictions on the number of packs of a medicinal product to be negotiated for one user.

Paragraph 3. Receptionable and non-prescription medicinal products intended for production animals may, in the case of the health unit, be traded to the users outside the pharmacies.

Paragraph 4. The Board of Health may lay down rules on the fact that medicinal products not covered by the apothecary shall be subject to the rules laid down in paragraph 1. 1, may only be delivered in accordance with the order of doctors, dentists or veterinarians. The Board of Health may also lay down rules on the drafting of such orders and rules for the supply of such medicinal products.

§ 61. The Board of Health shall decide on the marketing authorisation for marketing authorization, by extension of the marketing authorization and where necessary, in the case of a medicinal product, the medicinal product must be prescriptive.

Paragraph 2. The Board of Health shall lay down rules on the medicinal products to be issued only after prescription and for the distribution of medicinal products into the supply groups.

Paragraph 3. The Board of Health shall lay down rules on the drafting of prescriptions and other prescriptions and substitutes and other prescriptions of prescription drugs and non-prescription medicinal products prescribed for prescription. In addition, the Board of Health shall lay down rules on the supply of medicinal products in exceptional cases, without security for payment.

§ 62. The Board of Health may lay down rules on the conditions for the prescribe and supply of medicinal products associated with a special programme for management, organisation and management of risks (risk management programme).

Paragraph 2. The Board of Health may, in exceptional cases, provide for specific restrictions to be specified in connection with the prescribed and the provision of a medicinal product which has a risk management programme referred to in paragraph 1. 1.

Chapter 7

Advertising, bonus, rebates, etc.

§ 63. Advertising for a medicinal product must be adequate and objectiable, and shall not be misleading or overdrive the properties of the medicinal product. Information in advertising must be in conformity with the approved product summary of the medicinal product.

§ 64. No advertising shall be adversated for :

1) medicinal products which are not legally to be negotiated or handed down in this country ; and

2) Magistrelle medicinal products.

§ 65. The Ori pharmacy should not be used in advertising for non-mail reserved medicinal products, cf. § 60, paragraph. 1 or other goods other than medicinal products, unless the person responsible for advertising can document the fact that the goods are generally negotiated in the pharmacist.

§ 66. The public must not be adversated for medicinal products, which :

1) are prescription-only,

2) is unsuitable for use without the examination of the patient for the diagnosis or surveillance of treatment, or

3) are subject to the rule of eeuphoria.

Paragraph 2. In the case of public opinion, anyone who is not a doctor, a dentist, veterinarian, pharmacist, pharmacist, veterinary nurse, pharmacist, midwife, bioanalyst, clinical diaptist, radiograf or students in one of these classes shall be considered.

Paragraph 3. The Board of Health may give trade unions for anything other than those referred to in paragraph 1. The health workers referred to in paragraph 2 shall be authorised to adverts them in accordance with paragraph 1. 1 the medicinal products referred to in the case of medicinal products having a particular interest in the use of medicinal products.

Paragraph 4. The prohibition in paragraph 1. Paragraph 1 does not include vaccination campaigns approved by the Board of Health.

§ 67. For the public, non-remunuation must not be provided for medicinal products. However, the Board of Health may authorise the provision of non-advertising of medicinal products to the public if the extradition does not take place in advertising.

Paragraph 2. The Minister for Health and Prevention shall lay down rules on the extent to which medicinal products are to be delivered free of charge to the products referred to in section 66 (2). 2, mentioned health professionals.

Paragraph 3. The Minister for Health and Prevention shall lay down rules on the activities of the pharmaceutical consultants.

§ 68. The holder of a marketing authorisation shall keep a copy of or other evidence for all advertising of the medicinal product concerned. The health and prevention minister shall lay down rules on the information to be retained, including information on the target group, content, use, release form, and distribution mode.

Paragraph 2. The one in paragraph 1. 1 mentioned material must be stored for 2 years. The material shall be made available to the Board of Health at the disposal of the Board of Health.

Paragraph 3. Where a marketing authorisation holder is advertised for a medicinal product, the obligation shall be incumlitiable in accordance with paragraph 1. 1 and 2 the person responsible for the advertised.

Paragraph 4. The Board of Health may provide all necessary information in order to verify that advertising of medicinal products, discounts and other services or processes which may have equivalent effect are in accordance with the provisions of this Chapter, including with rules laid down in accordance with section 67 (3). 2 and 3, or section 70 (3). 1.

§ 69. The Board of Health may require that advertising in violation of section 63 to 68 or with rules laid down in accordance with section 67 (s). Article 70 (2) and section 70 (3). 1, cease to be terminated.

Paragraph 2. The Board of Health may require the person responsible for an illegal advertising to publish a decision pursuant to paragraph 1. 1 or an enrichment of the advertising. The Board of Health may determine the form and content of the public service, including where it is to take place.

§ 70. The Minister for Health and Prevention may lay down detailed rules on the advertising of medicinal products, discounts and other services or processes which may have a similar effect.

Paragraph 2. The Minister for Health and Prevention may lay down rules that the Board of Health at the request of undertakings should give an opinion on its views on the legality of proposed advertising measures.

§ 71. The Board of Health may lay down rules that, in special cases, it may be permitted to adversate in the case of dental products not covered by Section 2 for the prevention of certain diseases in humans.

§ 71 a. There must not be any trade in an apothecary reserved for medicinal products, cf. § 60, paragraph. The benefits shall be paid or paid for the benefit of the medicinal product for the user of the medicinal product. However, in the case of sale of pharmacy reserved medicinal products to hospitals, bonuses are paid to the health owner.

Section 71 b. The holder of a permit after paragraph 39 (5). 1 (discounts giver), as part of the trade in an apothecary reserved for medicinal products, cf. § 60, paragraph. 1, an apothecary alone discounts, which is matched by the cost savings of the discounts giver. The discount must be proportionate to cost savings and must be a reduction in the price.

Paragraph 2. The Rabat giver shall prepare and publish information on access to the obtaining of the information referred to in paragraph 1. 1 mentioned discounts from this as part of the trade in apothecary-reserved medicinal products (source duty).

Paragraph 3. The Ministry of Health and Prevention shall lay down detailed rules for the granting of the aid referred to in paragraph 1. 1 mentioned discounts and the aboom referred to in paragraph 1. 2 (1), paragraph 2, and on accounting conditions, the management authority and the execution of auditing on the benefits of the discounts.

Paragraph 4. Pharmacists must not as part of the trade in the products referred to in paragraph 1. 1 mentioned medicinal products, request or receive discounts which are not in accordance with the information provided by the disorer in accordance with its source obligations and published.

Paragraph 5. For three years, rabbits and pharmacists shall keep documentation for the records referred to in paragraph 1. 1 mentioned discounts provided and received as part of the trade in apothecary reserved medicinal products. The minister of health and prevention may lay down rules on the documentation to be retained.

Paragraph 6. The Board of Health may provide discounts and pharmacists to supply all information necessary for the purpose of checking whether discounts are granted and received in accordance with paragraph 1. The provisions of paragraphs 1 and 4 and the rules adopted pursuant to paragraph 1. 3.

§ 71 c. The representatives of the Board of Health shall have appropriate credentials and without a court order of access to pharmacies and companies which are holders of a permit in accordance with section 39, paragraph 1. 1, in order to verify compliance with the provisions of section 71 a and section 71 b (b), 1, 2 and 4 and paragraph 1. FIVE, ONE. pkt; and in rules issued in accordance with section 71 b (b), 3 and paragraph 1. FIVE, TWO. Act.

Chapter 8

Information on medicinal products

§ 72. The Board of Health shall make the following information available to the public on the Health Board's website, cf. however, paragraph 1 2 :

1) The health management decisions on issue, suspension and revocation of marketing authorisations.

2) Terms and Conditions Associated to Marketing Permissions in accordance with section 9 (4). 1 and 2, and details of any deadline for fulfillment of the terms and conditions.

3) Health Services authorised product sumes for medicinal products have been approved by the Board of Health.

4) An assessment in Danish or English of the material for marketing authorisations issued by the Board of Health, in the form of a public evaluation report. For medicinal products for human marketing to human beings, a Danish or English summary of the evaluation report shall also be published.

5) Supplementary notes for medicinal products subject to a marketing authorisation in this country.

6) Summary of risk management plans and programmes for medicinal products for human beings.

7) The list of medicinal products subject to additional surveillance within the European Union, cf. Article 23 of Regulation (EC) No, The 726/2004 published by the European Medicines Agency's web portal on medicinal products.

8) Information on how health workers and patients can report suspected adverse reactions to the Health Services, including on digital reporting.

9) Business orders, agendas and meeting minutes accompanied by the decisions taken, poll results and explanations of vote, including minority opinion, for the advice and furnace referred to in Chapter 13.

Paragraph 2. Notwithstanding paragraph 1 1 shall not make the Board of Health information that is exempt from the public under the rules of access to documents available to the public.

Paragraph 3. The Board of Health must also inform the public when special health matters are, by the way, necessary. In this respect, the Board of Health may, notwithstanding paragraph 2 publish the name of the legal or physical person who has committed an offence.

§ 72 a. The Board of Health shall organise meetings with the participation of patients and consumer organisations in order to provide public information on measures taken to prevent and combat the falsification of medicinal products.

§ 73. The Board of Health may provide information on medicinal products and the appropriate use of medicinal products.

Paragraph 2. As a basis for the information company, the Board of Health may use all necessary information at the disposal of the Management Board in its activities.

Paragraph 3. The information referred to in paragraph 1. 2, after the Minister for Health and Prevention, may be provided to associations of doctors, dentists, veterinarians, pharmacists and pharmacists, and to undertakings whose purpose is to provide medical information on medicinal products, but not ; information that may be attribudeable to individuals.

Paragraph 4. The Board of Health may publish information on adverse reactions produced by medicinal products, but not information which may be attribucied to individuals.

Paragraph 5. When the Health Authority, on the basis of pharmacovigilance, informs concerns about the safety of a medicinal product for people in accordance with paragraph 1. In the case of 1 or 4, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities of the other EU/EECE countries at least 24 hours before publication of this information. However, the time limit for notification may be deviated if the publication is required in the interests of public health protection.

§ 74. The Ministry of Health and Prevention may instrumental health care professionals to inform health professionals of medicinal products according to the rules laid down.

Chapter 9

Mean supplies

§ 75. The person who brings a medicinal product to human beings on the market and wholesalers by such a medicinal product shall ensure the appropriate and continued delivery of the medicinal product in accordance with the rules laid down by the Board of Health, provided that the medicinal product concerned is :

1) A medicinal product which is subject to the subject of apothecary, cf. § 60, paragraph. 1.

2) A serum, a vaccine, an immunological test preparation or a medicinal product made from plasma.

3) It's a radioactive drug.

4) A medicinal product, including specific packaging sizes, pharmaceutical forms and the reinforcement of the medicinal product, which, according to the procedure for the Health Management Board, may be negotiated to the users outside the pharmacies, cf. § 60, paragraph. 2.

SECTION 76. The Minister for Health and Prevention may lay down rules on the obligation of establishments approved by the Board of Health after paragraph 39 (5). 1, in the case of emergency services and in the event of accidents and disasters, including acts of war, to take measures to maintain the supply of medicinal products.

Paragraph 2. The rules set out in accordance with paragraph 1 shall be adopted. 1 may include provisions concerning :

1) The undertaking ' s obligation to take measures for the relocation and distribution of commodities used, are produced or redeployed in their normal business.

2) Payment and delivery conditions for medicinal products moved or propagated in accordance with the rules laid down.

3) The availability of pharmacies and ordermatics to deliver medicinal products to pharmacies and orderpots.

4) The access to the health management system to provide the firm ' s specific requirements to implement measures deviating from the rules laid down.

Paragraph 3. Comes to the rules set out in accordance with paragraph 1. 1 or one of the health services issued by the Board of Health pursuant to the rules laid down in accordance with paragraph 1. 1, financial loss for a company, the State shall be liable for liability under the general rules of law.

Paragraph 4. The replacement shall be replaced by a lack of minable agreement in accordance with rules laid down by the Minister for Health and Prevention.

Chapter 10

Prices, sortiment, item numbers, and statistics

Prices and sortiment

§ 77. The person who brings an apothecary reserved to the market in Denmark shall notify the health department of the apothecary of the apothecary, and changes thereto on the medicinal product concerned within a period of 14 days before the price is to enter into force. However, the notification requirement shall not apply to medicinal products exempt from the marketing authorisation requirement in accordance with section 11.

Paragraph 2. The Minister for Health and Prevention may lay down rules on notification of notification under paragraph 1. 1, including a minimum limit for the changes to pharmacies of pharmacies for human beings, and the requirements for notification, including notification of notification by notification of electronic means.

§ 78. The minister for health and prevention may lay down rules that the subject of a medicinal product exempted from apothecary reservations on the market in Denmark shall notify the Board of Health, the papacing sizes of the medicinal product in, including the notification of any modification to the word.

Paragraph 2. The minister for health and prevention may lay down rules that, for some medicinal products exempted from apothecary reservations, the product of the medicinal product on the market in Denmark should notify the apothecary of the medicinal product to be charged at the level of the packing ; NHS.

Paragraph 3. Notification in accordance with paragraph 1. 1 and 2 shall be the Board of Health at the latest 14 days before the entry into force of the market or a package shall be placed on the market, changed or withdrawn from the market.

Paragraph 4. The Minister for Health and Prevention may lay down detailed rules for notification to the Board of Health in accordance with paragraph 1. 1-3, including a minimum limit for the changes to apothecary prices for medicinal products, and the requirements for notification, including notification of notification by notification of electronic means.

§ 79. The health management treatment of the pharmacies referred to in section 77 and under rules laid down in Article 78 shall not constitute approval.

$80. The person who brings a medicinal product to the market in Denmark shall indicate, at the request of the Board of Health, indicate the quantity of a given medicinal product to the market.

Paragraph 2. The Minister for Health and Prevention may lay down rules that the person who brings a medicinal product to humans on the market and wholesalers must inform the Board of Health of the expected and actual delivery failure.

Paragraph 3. The Ministry of Health and Prevention may lay down detailed rules on information and notification of information and notification under paragraph 1. One and two.

Paragraph 4. The Board of Health may lay down requirements for the submission of notification of notification of paragraph 1. 2, including submission of electronic means.

§ 81. The Board of Health shall inform the pharmacists of which packages of products are placed on the market in, including on any modification to the variety, and whether the consumer price of medicinal products is concerned. The notification takes place at the price of medicine, cf. $82.

Paragraph 2. However, the Board of Health may, on the basis of information received after Article 80 (3), can 1, do not notify the pharmacies of the consumer price of a medicinal product.

Paragraph 3. The Minister for Health and Prevention can lay down rules that information on medicinal products that cannot be delivered are not included in the price of medicines. In this context, the Minister may lay down rules on the notification of the health management of the pharmacists on alteration of the grant price, cf. public health insurance legislation if the medicinal product which provides the basis for the fixing of the grant price in a grant group cannot be delivered.

$82. In Medicinal Prices, the Health Board shall publish medicinal products covered by Section 77 and rules laid down in accordance with Article 78, information on :

1) extradition group,

2) a limitation of the number of packages available for the payment of each ; an expedition outside of drugstore.

3) medical specials empowered to prescribe the medicinal product ; and

4) the grant price, including, where appropriate, the unit grant price.

Paragraph 2. The minister for health and prevention may lay down detailed rules for the price of medicine, including :

1) the information which, in addition to those referred to in paragraph 1 1 may or shall be recorded in the Pharmaceutical Awards,

2) The disclosure of certain information in Medicine Prices prior to publication, including the precise time for such communication, shall be the health management board ; and

3) The disclosure of the information to the health management of Medicines Prices, including the precise time for such publication.

Paragraph 3. Medicine prices are not recorded in law-law.

Item Numbers

§ 83. Each individual pharmacovigilance must bear a unique item number. Item numbers shall be assigned by the Board of Health at the request of the product which puts the medicinal product on the market in Denmark.

Paragraph 2. The Board of Health may lay down detailed rules on the number of the item numbers, including that the intake of medicinal products to animals for animals must be fitted with a separate item number, that the entry into service of a given item must be reported to the Board of Health, and that : certain pharmaceutical groups shall be excluded from the requirement laid down in paragraph 1. ONE, ONE. Act.

Paragraph 3. On terms of conditions laid down by the Board of Health, the task referred to in paragraph 1 may be the case. ONE, TWO. arrangements, for an agreed period, to a private institution. Equine. If the terms of the transition are to be overtaken, the Board of Health shall deprive the institution of the assignment

Paragraph 4. The Board of Health may lay down requirements for notification of the alert for the Health Services, cf. paragraph 2, including that reporting must be digitally.

Statistics

§ 84. Companies producing, introducing, carrying out, stockpiling, distributor, distributor, distributor, distributor, splitter or packaged medicinal products, and the associations and inter-branch organizations of such undertakings shall be subject to rules laid down by the Minister on health and Prevention the Minister or the authority the Minister shall designate to receive the information, information in electronic form, etc. of medicinal products.

Paragraph 2. The Minister for Health and Prevention or the Authority appointed by the minister to receive the information may disclose information subject to rules laid down in accordance with paragraph 1. 1 to the public, including publication of statistics on the reproduction of all medicinal products and medicinal products.

Paragraph 3. The Minister for Health and Prevention may, from the authority the Minister appoints to receive the information, can receive the same information and transmit them to the same extent as the said authority.

Paragraph 4. The establishments and associations, etc., referred to in paragraph 1. In addition, at the request of the Board of Health, the Board shall give the Board of Health Information in electronic form, etc. of medicinal products. The relevant information may be disclosed in accordance with paragraph 1. The Board of Health shall lay down detailed rules for this.

§ 84 a. The minister for health and prevention may lay down rules on the information on medicinal products, including confidential information, Health Services, to the authority the Minister designates to draw up and publish statistics ; the circulation of medicinal products. The authority concerned may use the confidential information in connection with the production of pharmaceutical statistics.

Chapter 11

Attempt

Non-clinical trials of medicinal products

§ 85. Execution of toxicological and pharmacological studies (non-clinical trials) in order to assess the safety of medicinal products for use in the application of clinical trials, application for marketing authorization or to maintain marketing authorisation may be required ; Only happen with the permission of the Board of Health.

Paragraph 2. The Minister for Health and Prevention shall lay down rules on the conditions for obtaining an authorization to carry out tests in accordance with paragraph 1. 1 on the information to accompany the application and the processing of the health management of the application.

Paragraph 3. In order to ensure compliance with the conditions laid down in paragraph 1. 2, the Board of Health may attach special conditions to the permit, including the time limit.

Paragraph 4. The Board of Health shall lay down rules governing the technical management, technical knowledge, the establishment and operation of establishments authorized in accordance with paragraph 1. 1.

§ 86. The Board of Health may withdraw or suspend a permit in accordance with Article 85 (3). 1 if the conditions of the permit or terms associated with this are not fulfilled if the establishment violates rules established by the Board of Health in accordance with Article 85 (3). 4, or if the establishment refuses to contribute to the control of health management after Article 87.

§ 87. The Board of Health shall check undertakings, etc., with permits in accordance with Article 85 (3). 1. The check includes planning, execution, monitoring, registration, reporting, and archiving of the tests. The Minister for Health and Prevention shall lay down detailed rules on this control activity.

Paragraph 2. The representatives of the Board of Health shall have appropriate credentials and without a court order of access to undertakings and so on with permits under Article 85 (3). 1 for the implementation of the provisions of paragraph 1. 1 mention of checks. The Board of Health may provide or invite the undertaking, and so on, to supply samples of the subject or substance under investigation (test substance). The management may require all information, including written material, necessary for the control establishment. The Board of Health may require changes and time limits for the implementation of the change in order to ensure compliance with the rules laid down in Article 85 (1). 4.

Paragraph 3. The Board of Health may disclose relevant information concerning authorisations issued in accordance with section 85 (3). 1, and about the check-up operation after paragraph 1. 2 to the European Commission and the pharmaceutical authorities in the other EU/EEA countries and in third countries.

Clinical trials with medicinal products and so on

§ 88. A clinical trial of medicinal products shall be carried out only when the Board of Health has authorised the study. In addition, in the trial of human trials, an authorisation has to be provided for the study by a scientific committee, cf. law on the scientific treatment of scientific research projects.

Paragraph 2. Attempts of medicinal products on human beings must be carried out in accordance with good clinical practice. The Board of Health shall lay down rules concerning good clinical practice, including the quality standards for planning, implementation and reporting of clinical trials.

Paragraph 3. Applications for a clinical trial shall be submitted to the Board of Health of the person, undertaking or institution responsible for initiation, management and, where appropriate, the financing of a clinical trial.

Paragraph 4. If the Board of Health has a reasoned objection, the sponsor may change the application once to take account of the objection. If the application is not amended in accordance with the notice, the application shall be rejected.

Paragraph 5. The agent shall inform the manufacturer or his representative on the application, at the same time as the submission of an application to the Health Care Board.

Paragraph 6. In the case of an application for drug trials on humans, the Board of Health shall notify its decision of the authorization pursuant to paragraph 1. 1 or on the application for authorisation to the affected scientific committee, cf. law on the scientific treatment of scientific research projects.

Paragraph 7. Sponsor or his representative must be resident in an EU/EEA country.

Paragraph 8. The Minister for Health and Prevention shall lay down detailed rules concerning the applications for authorisation for clinical trials shall contain and on the processing of such applications.

$89. When an attempt has been initiated, the sponsor may only change the test protocol according to rules laid down by the Ministry of Health and Prevention.

Paragraph 2. Sponsor must

1) notify the Health Services without delay, if during the trial, unexpected and serious adverse reactions occur ;

2) prior to 15 days, the Board of Health shall notify the Board of Health in the event of an attempt to terminate earlier than planned and provide the Board with a clear justification for the interruption,

3) annually, during the whole trial period, a list of all the serious adverse reactions taken during the experimental period shall be drawn up and a report on the safety of the test subjects and submitted them to the Board of Health and

4) no more than 90 days after completion of the study, the Health Board shall inform the Board of Health that the experiment has been completed and, as soon as possible, and, within one year, submit the test results to the board.

Paragraph 3. The minister of health and prevention shall lay down rules on the rules laid down in paragraph 1. 2 mentioned information.

Paragraph 4. The Minister for Health and Prevention shall lay down rules on the obligation to notify others, including those responsible for clinical trials and the pharmacovigilance authorities of the other EU/EEA countries, whether or not they are in accordance with paragraph 1. 2 reported information.

§ 90. The Board of Health may, to the sponsor and to the doctor, dentist or veterinarian responsible for the practical implementation of the study (investigator), may make a term for the experiment.

Paragraph 2. The health inspector may, during and after the implementation of a clinical trial of medicinal products, including in the course of the examination of an application for marketing authorization and following up the marketing authorization, any checks on the application of a marketing authorisation ; company, etc., performing or carried out a clinical trial. The Management Board may provide for the supply of all information, including written material, necessary for the checks.

Paragraph 3. In the light of a request from a competent authority of another EU/EEA country, on the basis of a request from a competent authority in another EU/EEA country, for the control of a clinical trial, control any activity, etc., carrying out or carried out a clinical trial of medicinal products. The Management Board may provide for the supply of all information, including written material, necessary for the checks.

Paragraph 4. As part of the control of health management in accordance with paragraph 1. 2 and 3 have the Management Board's representatives against appropriate legitimacy and without a court order of access to establishments, hospitals, practices and other places that are affected by the implementation of the study.

Paragraph 5. Dissemination and treatment of information on health conditions and other purely private and other confidential information as part of the control of the Health Management Board, cf. paragraph 2-4, happen without the consent of the subject.

Paragraph 6. In the case of medicinal products for human beings, the control of health management shall be carried out in accordance with paragraph 1. 2 and 3 that good clinical practice is complied with. The Minister for Health and Prevention lays down detailed rules on this control.

Paragraph 7. If an investigator or other party is not in the study, the Board of Health shall submit to these proposals to address these proposals to address the problem and submit the proposal to the person concerned ; the scientific committee, the Commission and the pharmaceutical authorities of the other EU/EEA countries.

Paragraph 8. During the trial, the Board of Health to the sponsor and investigator may require a change of or suspended attempt, or the Management Board may prohibit the attempt. The Minister for Health and Prevention shall lay down detailed rules on this matter.

Niner. 9. In the case of a decision to stop or prohibit a drug trial for human beings, the Board of Health must promptly notify its decision and its reasons for the Scientific Committee, the European Medicines Agency, the European Commission, and the pharmaceutical authorities of the other EU/EEA countries.

§ 91. The Board of Health shall provide for the introduction of information on all clinical trials of medicinal products on humans, on which the Management Board has decided, in a European database. The Ministry of Health and Prevention shall lay down detailed rules on the information to the Board of Health and of the information provided by the Board of Directions and of the Management of the Administrative Board.

Paragraph 2. The Board of Health may disclose relevant information on clinical trials to the European Medicines Agency, the European Commission, the pharmaceutical authorities of the other EU/EEA countries and the Scientific Committee for the Scientific Committee. The Minister for Health and Prevention shall lay down detailed rules on this matter.

§ 92. Clinical trials shall be required to comply with the applicable standards for good manufacturing practice. Compliance with this shall be subject to the testing of clinical trials in the Health Management Board pursuant to Article 90 (3). 2.

Paragraph 2. The Board of Health may, upon reasoned request, communicate information from the checks provided for in Article 90 (2) 2, to the European Medicines Agency, the pharmaceutical authorities of the other EU/EEA countries and the Scientific Committee for the Scientific Committee.

Paragraph 3. The Board of Health shall lay down detailed rules on the manufacture, import, marking and distribution of, and control of medicinal products for clinical trials.

FormRequirements

§ 92 a. The Minister for Health and Prevention may lay down rules on the requirements for applications and information provided for in this Chapter, including that the application or notification shall be made electronically.

Non-intervention security surveys

§ 92 b. A non-intervention safety examination of an approved medicinal product for human beings, which is a condition for a marketing authorisation, as determined by the marketing authorisation, cf. Section 9 (1). First, when the Board of Health has authorised the investigation, the second Health Services Board shall first be implemented. The Management Board shall be available when the investigation is to be carried out only in Denmark.

Paragraph 2. The Minister for Health and Prevention shall lay down detailed rules on the applications for authorisation pursuant to paragraph 1. 1 shall include, and the processing of such applications.

Paragraph 3. When a non-intervention security inquiry is permitted in accordance with paragraph 1. 1 has been initiated, the marketing authorization holder may only make significant changes to the protocol on the subject of rules laid down by the Minister for Health and Prevention.

§ 92 c. The holder of a marketing authorisation shall send a report on the results of a non-intervention safety survey to the Health Care Board. Furthermore, if a study is carried out in other EU/EEA countries, the report shall also be forwarded to the countries concerned. Transmission shall be completed within 12 months of the completion of the examination of the data submitted by the investigation, unless the Board of Health has authorized a derogation from this time limit.

Paragraph 2. The Minister for Health and Prevention shall lay down rules on the requirements for content and the submission of the measures referred to in paragraph 1. 1 mentioned reports, including separate requirements for reports from non-intervention safety tests, which are a condition for the marketing authorization.

§ 92. Non-intervention safety examinations of authorised medicinal products must not be carried out if the use of a medicinal product is thus promoted.

Paragraph 2. Remuneration to health professionals who have taken part in a non-intervention safety examination of an approved medicinal product may only be compensated for for the time spent and expenditure related to the investigation.

Chapter 12

Certain substances which may be used as medicinal products for animals

§ 93. Manufacture, importation, export, stockpiling, distribution, distribution, distribution, division, packaging, possession or availability of substances which may be used as medicinal products for animals which have calculated the characteristics of the Board of Health of the Board of Health, only when notified to the Health Service and the company have received receipt of notification in advance. The Board of Health shall lay down detailed rules for the procedure for notification, etc.

Paragraph 2. The provision in paragraph 1 shall be 1 shall also apply to products in which one or more of the substances in question are included as a constituent.

Paragraph 3. Private persons must not also acquire, possess or have any substances or products covered by paragraph 1. 1 and 2, unless the substance or product has been acquired through a company that filed a notification to the Board of Health and received acknowledgement for this, cf. paragraph 1. The substances and products must not be administered animals, used on animals, transferred or resold, unless the Board of Health in special cases has given permission for it. The Board of Health shall lay down rules on this

Paragraph 4. The Board of Health may lay down rules on the negotiation and supply of the substances and products covered by paragraph 1. 1 and 2, including that extradition may be made only by the requisite sign of the local Chief of Police. The Board of Health may lay down detailed rules on the drafting and content of the requisition, as well as on the duty of private persons to retain a copy of the requisition.

Paragraph 5. The Board of Health may lay down rules concerning the requirements for notifications and applications pursuant to paragraph 1. 1 and 3, including notification or application shall be made by electronic means.

$94. The Board of Health shall establish a register of establishments and pharmacies which make notification pursuant to section 93 (3). 1.

Paragraph 2. The establishments and pharmacies referred to in paragraph 1. 1, shall keep accurate records of all transactions with the substances and products concerned. The Board of Health shall lay down rules on this

§ 95. The Board of Health shall check companies and pharmacies which are subject to section 93 (3). 1, and they after paragraph 94 (1). 2, kept records.

Paragraph 2. Following negotiations with the minister in question, the Minister for Health and Prevention may lay down rules on the participation of other authorities or institutions by means of control tasks in accordance with paragraph 1. 1.

Paragraph 3. Representatives of the inspection authority shall have at all times against appropriate credentials and without a court order of access to public and private properties and premises, as well as access to the testing of substances and products and other products to the inspection authorities ; all information, including written material, necessary for the control establishment.

Chapter 13

Council and name, etc.

§ 96. The Board of Health may consult the Mediemedial Board on matters of :

1) Issue, alteration, suspension or revocation of marketing authorisations for medicinal products.

2) Monitoring of adverse reactions and other risks of medicinal products.

3) weighing up the benefits of a medicinal product to the risks of the medicinal product.

4) Clinical trials with medicinal products.

Paragraph 2. The Medical Board shall consist of a maximum of 15 members, two of whom shall represent the interests of patients and consumers.

§ 97. In cases of requirements for the quality of medicinal products, cf. Section 52, Health Services may consult the Pharmacopoeia board. The Pharmacopoeia Board shall consist of not more than 6 members.

-98. Members of the name referred to in sections 96 and 97 shall be appointed for four years at a time of the Ministry of Health and Prevention, by the Health and Health Board setting. The Minister nominates one of the members of the members of the House and a Vice-President of the House.

Paragraph 2. The Minister for Health and Prevention may refer further tasks to the latter.

Paragraph 3. The names can make up for statements by experts in particular.

Paragraph 4. With the Minister for Health and Prevention Approval, a standing committee may be set up under the latter. For members of these, the Minister may not be able to prunes people who are not members of the jury.

§ 99. The Ministry of Health and Prevention shall establish rules of procedure for the furnace referred to in sections 96 and 97.

§ 100. Members of the denominated in section 96 and 97 and experts who make declarations to the latter shall be responsible for the confidentiality of Article 152 of the penal code of Article 152, to all the non-they who are to be kept secret of their activities ; knowing that when the information is classified as confidential.

§ 101. In the case of adverse reactions and other risks of medicinal products, the Board of Health shall consult the Council for Medicinal Products for the Health Services.

Paragraph 2. The Council for Medicinal Products shall consist of not more than 11 members. Among the members, there must be representations on health professionals, pharmaceutical companies, pharmacists and other retailers of medicinal products, patients and consumers.

Paragraph 3. The Council for Medicinal Products shall be set up by the Board of Health in accordance with public record. The Board of Health shall appoint 1 President of the Council members.

Paragraph 4. The Board of Health shall lay down rules for the Council of the Medicinal Products Council.

independence of the health management

§ 102. The Board of Health, Members of the Board of Health, Board, Name and Committee set up under this law and other persons shall consult the Board of Health, including in the processing of decisions on the authorisation, control and the efficuse of medicinal products, must not have any economic or other interests in the pharmaceutical industry, which may affect their impartiality.

Paragraph 2. The persons referred to in paragraph 1. 1, each year, must make a declaration on their economic interests in the pharmaceutical industry.

Chapter 14

Fees

§ 103. The Ministry of Health and Prevention may establish rules for the payment of the Health Management Company under this law and pursuant to rules laid down under the law, including

1) fees for medicinal products and pharmaceutical companies, and to the operators, importers and distributors of active substances ;

2) fees for the registration of medicinal products,

3) the payment for allocation, etc., of the product numbers for medicinal products,

4) the payment of the expenses incurred by the Health Board on a voyage and residence if the examination of an application or control of the approved medicinal product requires that the Board of Health carries out an inspection of a company situated in a third country,

5) fees for the notification of prices and the notification of the pharmacies of medicinal products for pharmacies,

6) fees for the notification of wrapping sizes on non-mail reserved medicinal products and

7) fees for the application for approval and charge for the testing of clinical trials.

Paragraph 2. Payment pursuant to rules laid down in paragraph 1. 1 may be recovered by panting.

§ 103 a. At the one authorized by the third paragraph of paragraph 39. 1, for the production of medicinal products for the production of animals, the Board of Health shall levy a charge as laid down in paragraph 1. 2-5 to finance initiatives to strengthen food safety and animal welfare.

Paragraph 2. The levy shall be fixed at 0,77%. by the distributor ' s turnover by simple greens of penicillin to production animals.

Paragraph 3. The levy shall be EUR 10,77%. by the distributor's turnover of critical important antibiotics for production animals.

Paragraph 4. The levy shall be fixed to 5,44%. by the distributor ' s circulation of other antibiotics to production animals.

Paragraph 5. The levy shall be fixed at 0,77%. by the distributor ' s circulation of other medicinal products for production animals, however, where a charge is not fixed in the case of the distributor ' s circulation of vaccines for the production of animals.

Chapter 14 a

Kundstatement

§ 103 b. The minister for health and prevention may lay down rules that standards for the quality and manufacture, control and storage of medicinal products referred to by the Health Services granted by the Board of Health in accordance with this law, shall not be established ; shall be introduced in the law of law.

Paragraph 2. The Ministry of Health and Prevention may lay down rules on how the Board of Health should give information on the content of the rules issued by the Management Board, cf. paragraph 1.

Paragraph 3. The Ministry of Health and Prevention may lay down rules that prescribe regulations and technical specifications which are not introduced in the law, cf. paragraph 1 shall apply even if they are not available in Danish.

Chapter 14 (b)

Appeal access

§ 103 c. The Minister for Health and Prevention can lay down rules on complaints against the health management decisions, including rules on complaints.

Chapter 15

Punishment, etc.

§ 104. Unless higher penalties have been inflited on the other legislation, penalty of fine or imprisonment shall be penalised up to four months of the sentence of the person who :

1) is breaching section 7 (3). 2, section 20, section 21, section 26, section 40 a, paragraph 2 or 3, section 41 (4). 1, section 41 (b) (b) Paragraph 1, section 42, paragraph. One or two, section 43 a, section 50, paragraph. Three, section 50 a, paragraph. 1, 50 d, section 53 (3). 1, Section 54, section 58 (3). 3, section 59, paragraph. Paragraph 1, section 60, paragraph. Paragraph 62, paragraph 2. 2, section 63, section 64, section 65, section 66, section. Paragraph 1, section 67, paragraph. ONE, ONE. pkt., section 68, paragraph. ONE, ONE. pkt., paragraph TWO, ONE. pktor, or paragraph, 3, section 71 a, section 71 b, paragraph 1. 1, 2, 4 or 4. FIVE, ONE. Pkt., section 83, paragraph. ONE, ONE. pkt., section 85, paragraph. Paragraph 1, section 88, paragraph. ONE, ONE. pkt., paragraph TWO, ONE. pktor, or paragraph, 5, section 92 (2). ONE, ONE. pkt., section 92 b (b). 1 and 3, Section 92 c (3). 1, Section 92 d, section 93, paragraph ONE, ONE. pktor, or paragraph, Two or three, section 94, paragraph. TWO, ONE. pkt; or Community regulations on medicinal products and pharmaceutical companies,

2) will override the terms provided for in a permit or approval under the law or rules laid down by the law,

3) is in violation of paragraph 46 (3). Paragraph 1, section 47, or section 90 (3). 8,

4) omits to comply with an obligation or information to be provided for in section 22 (2). Paragraph 1, section 23, section 24, section 25, paragraph 25. 1 or 2, section 35, section 43, section 43 (b), paragraph 43. ONE, ONE. pkt., section 44 a, section 44 b, section 44 d, 2. pkt., section 46, paragraph. 1, 50 f, 50 g, section 53 (3). Paragraph 1 (1). 3 or 3. FIVE, TWO. pkt., section 54 a, section 68 (6). TWO, TWO. pktor, or paragraph, 4, section 69, section 70 b (3) (b) 6, section 80, paragraph. 1, Article 84 (4). Paragraph 1 or paragraph 1. FOUR, ONE. pkt., section 87, paragraph. TWO, TWO, FOUR. pkt., section 89, paragraph. Two, section 90, paragraph. TWO, TWO. pkt., paragraph THREE, TWO. pktor, or paragraph, Article 95 (8) or Article 95 (5). THREE, TWO. pkt., or

5) refuse representatives of the inspection authority in accordance with section 25 (5). 3, section 44 (4). 2, section 44 d, 1. pkt., 50 e (s). 2, section 53, paragraph. FIVE, ONE. pkt., section 71 c, section 87 (3). TWO, ONE. pkt., section 90, paragraph. 4, or Section 95 (3). THREE, ONE. Act.

Paragraph 2. Unless higher penalties are inflited on the other legislation, penalty shall be penalized for a sentence of 1 year and 6 months in violation of section 7 (7). 1, section 38 (a) (a), Paragraph 1, or Section 39 (2). 1 or 2, or fails to comply with an injunction issued in accordance with section 46 a.

Paragraph 3. The rules set out under the law can be punished for the penalties imposed on the rules laid down in the rules.

Paragraph 4. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 104 a. The Minister for Health and Prevention may lay down rules that the Health Services Board, in more detail, on punishment after section 104 (2) shall be subject to the rules on penalties. 1, or rules laid down in accordance with the law which is not deemed to be higher than penalty in a fine-in-presentation, the case may be decided without trial, if the offence committed by it pleads to the infringement and the case ; shall declare itself prepared before any further specified period, which may be extended, after application, to pay a fine as indicated in the penalty. The Minister for Health and Prevention can also lay down rules that the requirement for the confiscation of medicinal products seized under Article 44 c may be adopted in the same way without legal proceedings.

Paragraph 2. The rules on the Law of the Court of Justice shall apply to the contents of an indictment and that a charge is not required to express an opinion shall apply mutatis muchal to a fine.

Paragraph 3. If the ticket is adopted, further proceedings shall be suspended.

§ 105. The Board of Health may impose on the one who disregards the submission of information pursuant to Article 84 (3). FOUR, ONE. pkt; and undertakings which disregarding the obligation to provide information in section 84 (4) ; 1, a tax. The tax is 500 kroner. per started week until the information is correctly submitted. The levy due to the Treasury shall be attributed to the panting.

Chapter 16

Entry into force, alteration and transitional provisions

§ 106. The timing of the law or parts of the law shall be established by the Minister for Health and Prevention ;

Paragraph 2. The Minister for Health and Prevention can repeal the law on medicinal products, cf. Law Order no. 656 of 28. July 1995.

Paragraph 3. Rules set out under the rule of medicinal products, cf. Law Order no. 656 of 28. July 1995, remain in force until they are replaced by or repealed by rules laid down in accordance with this Act.

Paragraph 4. The first one. in January 2007, Section 81 (2) is amended. THREE, TWO. Pkton, 'Law on Public Health Insurance' to the 'health law'.

§ 107. All authorisations and authorisations granted under law no. 327 of 26. In June 1975 on medicinal products with subsequent amendments valid at the time of the entry into force of the law, they shall remain in force until they were amended or repealed in accordance with the rules of the law.

Paragraph 2. A marketing authorisation for a medicinal product may not be limited to a time limit, cf. § 27, paragraph. 2, where a marketing authorization has been extended pursuant to this law, where a holder of a marketing authorization has submitted an application for the marketing authorization to be granted before the entry into force of this law, the Board of Health may require : additional information provided that the application does not comply with the requirements of this Act ; the Board of Health may dispense from the period of application in section 27 (3). 3, for medicinal products whose marketing authorization expires within six months of the entry into force of the law.

Paragraph 3. For medicinal products subject to a marketing authorisation at the time of entry into force of the law, the 3-year deadline shall begin in section 28 to run at the entry into force of the law.

§ 108. (Udelades)

-109. (Udelades)

§ 110. The law does not apply to Greenland and Faroe Islands.

1) The law provides for the implementation of 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. Paragraph 311, page 1, as amended by Regulation (EC) No, by the Regulation of the European Parliament and of the Council. 596/2009 of 18. June 2009, EU-Official Journal 2009, nr. In 188, page 14, 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. In 311, page 67, as amended in particular by Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, page 74, and Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, page 74, parts of Directive 2001 /20/EC of the European Parliament and of the Council of 4. April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice through the conduct of clinical trials of medicinal products for human use, in the Official Journal of the European Communities, no. L 121, page 34, parts of Council Directive 90 /167/EEC of 26. March 1990 laying down the conditions for the preparation, marketing and use of feed medicinal products in the Community, the Community Official Journal of 1990, In 1992, p. 42, parts of Parliament and Council Directive 2004 /9/EC of 11. February 2004 on the inspection and verification of good laboratory practice (GLP), EU Official Journal 2004, nr. L 50, page 28, and parts of Directive 2004 /10/EC of 11. February 2004 on the approximation of legislation on the application of principles of good laboratory practice and control of their use in the case of chemical substances, the EU Official Journal 2004, nr. I'm 50, page 44.