Chapter 1	Definitions and scope
Chapter 2	General prohibition
Chapter 3	Promotion to the public
Chapter 4	Advertising to health professionals
Chapter 5	Advertising for homeopathic medicinal products
Chapter 6	Comparative advertising, storage of advertising, pharmaceutical consultants
Chapter 7	Economic benefits
Chapter 8	People employed in the sale of medicinal products outside pharmacies
Chapter 9	Cost-based rebates to apothecary and others
Chapter 10	Penalty and effective provisions
Appendix 1	Statement of Assurance for Medicinal Provider Service Provider's Cost-based Discount Service Provider

Publication of the advertising of medicinal products 1)

Purline to section 67 (4). 3, section 68, paragraph. Paragraph 1, section 70, paragraph 1. 1, section 71 b, paragraph 1. 3 and 5, and section 104 (3). Three, in the law. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 1557 of 20. December 2006 and Law No 1258 of 18. December 2012, and in accordance with section 3 b (b). Paragraph 1, and section 72, paragraph 1. 2, in the announcement of the apothecary, cf. Law Order no. 855 of 4. August 2008 shall be determined :

Chapter 1

Definitions and scope

§ 1. For the purposes of advertising of medicinal products, all information activities, customer searches or the holding of a shelf-life which are designed to promote the provision, supply, sale or consumption of medicinal products shall be taken into account.

Paragraph 2. The public shall be taken to mean anyone who is not a doctor, a dentist, veterinarian, pharmacist, nurse, veterinary nurse, pharmacist, or students in one of these classes, cf. Article 66 (3) of the medicinal product. 2.

Paragraph 3. In the case of health-care professionals, doctors, dentists, veterinarians, veterinary nurses, veterinary nurses, pharmacies, midwives, bioanalysts, clinical graduates, radiographers and students in these professions.

Paragraph 4. Vendors shall mean holders of authorization pursuant to Article 39 (3) of the medicinal product. 1, for the manufacture, introduction or negotiation of medicinal products.

Paragraph 5. Pharmaceuticals reserved for medicinal products for medicinal products to be traded only to the users through pharmacies, cf. Article 60 (3) of the medicinal product. 1.

§ 2. The rules on advertising for medicinal products in Chapter 7 of the medicinal products and in this notice shall not apply to :

1) The tagging and package leaflet of doctors.

2) Individual correspondence, if necessary accompanied by non-advertising documents, which serve to answer specific questions about a specific medicinal product.

3) Necessary and specific information or documentation that serves security and not adversarial purposes.

4) Prilists, product catalogs, and so on. that do not contain any other information about the medicinal products other than names and prices. The publications must not contain information on competing medicinal products.

5) Information on health and disease, provided that no direct or indirect reference is made to specific medicinal products.

6) Patient information folders provided by the receptor in connection with the prescribed by a medicinal product or of the pharmacy in connection with the delivery of a medicinal product and containing only objective information of the importance of the patient and its person ; Relative. The information in this folder must not be in conflict with the product summary.

7) Press releases,

a) containing short information about a medicinal product,

b) that have a general news value,

c) they have the press as a target group, and

d) to be sent to or made available to a majority of journalists or media for the purposes of journalistic evaluation and processing before publication.

8) Unredacted and unauthorised rendering of government-approved information on a medicinal product in the form of a package leaflet, product summary or public evaluation report, as provided for in the case of a medicinal product. Article 72 (3) of the medicinal product. 1, provided that such information is made available in such a way that users must actively seek information.

Chapter 2

General prohibition

§ 3. No advertising shall be adversated for :

1) medicinal products which are not legally permitted to be negotiated or made available in this country, cf. the section 64 of the medicinal product. 1,

2) Magistrelle medicinal products, cf. the section 64 of the medicinal product. 2,

3) medicinal products for non-clear and clinical trials when a marketing authorisation has not been issued for the medicinal products, cf. Article 7 of the medicinal product,

4) medicinal products sold or handed out in accordance with a special extradition permit in accordance with Article 29 of the medicinal product ; and

5) sera, vaccines, specific immunoglodents and other immunological test preparations not subject to a marketing authorisation, sold or handed out from the Serum Institute or Veterinary Institute at the Danish Technical University of Denmark ; According to the medical officer's section 30.

Chapter 3

Promotion to the public

General

§ 4. Advertising to the public must be drawn up to make it clear that it is advertising and advertising of a medicinal product.

§ 5. Advertising, except for the cases referred to in section 6 and section 7, contain the following information :

1) Name and common name of the medicinal product.

2) Paking sizes.

3) Dateated price (register price) including VAT and a reference to a daily certificate of benefits in medicine price ser.dk if the medicinal product is reserved for the pharmacist, cf. Article 60 (3) of the medicinal product. 1.

4) Effect, cf. however, section 10 (1). 1, no. 13.

5) Side effects.

6) Dosage.

7) An express and indelible appeal to read the information in the package leaflet or on the packaging.

8) Other information necessary for the correct and appropriate use of the medicinal product, e.g. alerts and interaction conditions.

Paragraph 2. Indication of effect shall be required for a traditional herbal medicinal product, cf. The medical officer, 34, no. paragraph 2 is formulated as follows : ' Traditional herbal medicinal products for use (Indication (s) are specified). The effect has been reimbursed only through long-term experience with the use of the plant (or plants) '.

Paragraph 3. Where a veterinary medicinal product is approved for use in several animal species and an advertising is exclusively used against persons having a specific interest in a single species, the duty of duty may be limited to information that is relevant to this particular species.

Promotion in the free, on film and on radio

§ 6. Promotion in the free, in the film, including video films, and in the radio shall include the following information :

1) Name and common name of the medicinal product. However, if the medicinal product contains more than one active substance, common denominator may be omitted.

2) Effect.

3) Essential side effects.

4) An explicit request to read the information in the package leaflet or on the package.

5) An explicit request to contact the doctor (or the veterinarian) or the pharmacy in case of doubt.

Paragraph 2. Indication of effect shall be made for a traditional herbal medicinal product in accordance with section 5 (5). 2.

Promotion on television

§ 7. Advertising on television shall include the following information :

1) Name of the medicinal product.

2) Effect.

3) Essential side effects.

4) An explicit request to read the information in the package leaflet or on the package.

5) An explicit request to read more about the medicinal product on the television channel of television and on the Internet. The holder of the marketing authorization for the medicinal product shall publish all the information referred to in section 5 on text television and the Internet.

6) Page number of text television and internet address where they are in point 5 mentioned information has been published.

Paragraph 2. The people in paragraph 3. 1, no. 1-5, that information shall either be specified in a readily readable text on the screen or in the spearean information.

Paragraph 3. The people in paragraph 3. 1, no. The information referred to in paragraph 6 shall be recorded in legible text on the screen.

Paragraph 4. The provisions of paragraph 1. 1, no. 1-4, also for advertising that is displayed on the monitors in pharmacies or other shops that sell medicinal products, provided that there is free access to the Internet from a PC, information stander e.l. in the pharmacy or store room. The ad shall also include :

1) An explicit invitation to read more about the medicinal product on the Internet. The holder of the marketing authorization for the medicinal product shall publish all the information referred to in section 5 of the Internet.

2) Internet address, where they are in number 1 mentioned information has been published.

3) Information that there is free access to the Internet from a PC, information stander e.l. in the pharmacy or store room.

Paragraph 5. All those in the first paragraph. 4 mentioned information must be specified in text on the screen.

§ 8. The information referred to in section 5-7 shall show (or is to be stated) so that the natural target group of the advertiseable shall be read (or hear and reach) the information.

Advertising on the Internet

§ 9. Advertising for medicinal products on the Internet is subject to the same rules as other advertising for medicinal products.

Paragraph 2. Promotion on the Internet is treated as advertising to the public, cf. however, paragraph 1 3.

Paragraph 3. Advertising on the Internet, where access to information by requirements for personal access passwords or in other effective way is restricted to health-care professionals and persons employed by the sale of medicinal products outside pharmacies, are treated as advertising for : health professionals and others.

Special requirements

§ 10. Public advertising to the public must not :

1) give the impression that it is superfluous to consult a doctor or veterinary surgeon ;

2) to give the impression that the effect of the medicinal product is safe (guaranteed) is without adverse effects or is better than or as good as the effect of another treatment, including another medicinal product,

3) give the impression that the general well-being can be improved through the use of the medicinal product,

4) give the impression that, if the medicinal product is not used, the general well-being can deteriorate.

5) exclusively or principally, to children,

6) include a recommendation from health professionals, researchers or other persons, associations of persons, institutions, undertakings, etc., which, by virtue of their assuage, can encourage the use of medicinal products ;

7) equine the medicinal product with foodstuffs, cosmetics or other consumer goods ;

8) to give the impression that the safety of the medicinal product or the product ' s effects is due to the fact that the ingredients are derived from nature,

9) be suitable to lead to mistaken self-diagnosis,

10) contain excessive, frightening or misleading statements on health,

11) in the case of excessive, frightening or misleading use of visual posts of changes in the human body caused by disease or lesions, or of an impact of a medicinal product on the human body or parts thereof,

12) contain information that the medicinal product has been approved by the competent authority ;

13) directly or indirectly refer to serious diseases or symptoms of serious diseases, or

14) include references to studies, literary works, periodicals and so on.

Paragraph 2. The provision in paragraph 1 shall be 1, no. 4, do not apply to vaccination campaigns approved by the Medicinal Products Agency, cf. Article 66 (3) of the medicinal product. 4.

Chapter 4

Advertising to health professionals

§ 11. Advertising for a medicinal product to health-care professionals shall include the following information :

1) Name and common name of the medicinal product. The common name must be specified with the same type and as eminent as the special name of the medicinal product. For combinations of combination without a common name, a clear indication shall be given of the common names of all active ingredients.

2) The name of the holder of the marketing authorization.

3) Indication of information as specified in the product summary. Advertising exclusively for a limited group of health professionals may be limited to the indication of the indication of the indication of the indication of the relevant group.

4) Contracts.

5) Side effects and risks.

6) Dosage.

7) Meat forms.

8) Paking sizes.

9) Dateated price (register price) including VAT and a reference to a daily certificate of benefits in medicine price ser.dk if the medicinal product is reserved for the pharmacist, cf. however, paragraph 1 4.

10) Delivery group.

11) Deferred Status.

Paragraph 2. If a medicinal product has been approved in several medicinal products with different uses, and advertising only deals with one of the pharmaceutical forms, the advertiser shall contain only the information on this medicinal product. It must also be stated in the commercial, that the medicinal product also exists in other medicinal products.

Paragraph 3. Where a veterinary medicinal product is approved for use in several animal species and the advertising deals exclusively with the treatment of a single animal, the advertiser shall contain only information on the treatment of this species. It shall also be stated in the advertisement that the medicinal product has also been approved for the treatment of other species.

Paragraph 4. The price may be omitted from advertising which :

1) will be sent over a longer period of time if the advertised is attached to a price list e.l. , or

2) they are targeted only in section 1 (1). Three, mentioned students.

Paragraph 5. The people in paragraph 3. 1 the information provided must be made so clearly that the natural target group of the advertised can be read to them.

§ 12. Advertising geared exclusively to health-care professionals may be limited to the name and common name of the medicinal product.

§ 13. Information material for a medicinal product to be sent or delivered to health workers in sales promoters shall contain at least the information referred to in paragraph 11 (3). 1, mentioned information, cf. however, section 11 (1). 2 and 3, and the date on which the material has been produced or last amended.

Paragraph 2. All information contained in paragraph 1. 1 The information material referred to must be accurate, current, verifiable and sufficiently detailed to ensure that the consignee may form a personal opinion on the therapeutic value of the medicinal product.

Paragraph 3. Citates, tables and illustrations from medical journals, scientific works, etc., which are used in the provisions of paragraph 1. 1 mentioned information material, must be disloyal, and the exact source must be reported.

Paragraph 4. Evidence of information concerning a medicinal product may, in addition to the product summary, only be used scientifically under-built studies. The studies must have been published in recognized and independent Danish or foreign works, trade journals, etc. The studies must have been subject to unwilling judgement prior to the publication of the publication of the studies.

Chapter 5

Advertising for homeopathic medicinal products

§ 14. Advertising for a homeopathic medicinal product, registered after a particularly simplified procedure without documentation of the therapeutic effect, cf. The medical officer, 34, no. 3, and the announcement concerning homeopathic medicinal products, etc., shall include the following information :

1) The scientific name of the homeopathic tribal or the homeopathic tribes followed by the dilution degree.

2) Content quantity.

3) Applicable mode and possible dosage.

4) Name and address of the registration holder.

5) Any important warnings.

6) The statement : ' Homopathic medicinal product without approved therapeutic indications ' means the medicinal product is for human use and the phrase : "Homopathic medicinal product for animals without approved therapeutic indications" when the medicinal product is intended for use in animals.

Paragraph 2. Advertising for a homeopathic medicinal product for animals shall in addition to the animals referred to in paragraph 1. 1 information shall include the medicinal product for which the medicinal product is intended for use.

Paragraph 3. In addition, the advertised may contain this information :

1) The possible distinguished name of the medicinal product (trade name), cf. The medical officer's section 58.

2) Mediocat form.

3) Composition.

4) If this is a person other than the registration holder.

Paragraph 4. The information referred to in paragraph 1 of the television may be that 1, no. 2-4, if they are instead published on the television channel of the television and registration holder, the internet address of the holder of the television network shall be deleted. The ad shall include an explicit invitation to read this additional information. Page numbers on text-TV and internet address must be marked in clear text on the screen.

Paragraph 5. On advertising, which is shown on the monitors in pharmacies or other shops that sell homeopathic medicinal products, the information referred to in paragraph 1 may be subject to the information provided for in paragraph 1. 1, no. 2-4, if they are published on the registration holder's home page, and there is free access to the Internet from a PC, information stander e.l. in the pharmacy or store room. The commercial must include an explicit invitation to read more about the medicinal product on the registration holder ' s website. The internet address must be marked in clear text on the screen.

Paragraph 6. The commercial may not contain any information other than those set out in paragraph 1. 1-5.

§ 15. For homeopathic medicinal products covered by § 14, the provisions of section 4, section 10 and section 20-30 shall apply.

Chapter 6

Comparative advertising, storage of advertising, pharmaceutical consultants

Comparative advertising

§ 16. If a commercial contains a comparison between several medicinal products, including a price comparison, the medicinal products, including the strengths, the wrapping, etc., the comparison shall be clearly visible. Comparison may only include medicinal products, including strengths and packaging sizes, which are objectively appropriate to compare, i.e. medicinal products with a duplicate area of application.

Paragraph 2. Comparative advertising must be prepared on the basis of the information contained in the product sumes for the medicinal products that are part of the comparison.

Paragraph 3. The impact of medicinal products in advertising to the public shall not be compared to the public, cf. ~ 10 (1)) 1, no. 2.

Storage of advertising material

§ 17. The person who advertises for a medicinal product shall keep a copy of or other documentation for the advertised, cf. Article 68 (3) of the medicinal product. One and three.

Paragraph 2. The ad shall be kept in printed form e.l. or digitally in the format of a normal format.

Paragraph 3. In addition to advertising itself, this information must be kept :

1) The target group of advertising, that is, the social circle that has been used in the advertising.

2) The distribution mode.

3) A list of media outlets where advertising has been shown.

4) The time period in which advertising has been used.

Medicinal Consultants

§ 18. Pharmaceuticals must have undergone appropriate training in the company they work for and be in possession of professional knowledge sufficient to provide accurate and complete information on the medicinal products they are displaying or mentions.

Paragraph 2. Medical consultants shall make available to the person visiting the product for each of the medicinal product available to the medicinal product. Product trisuction must be supplemented with information on prices (if the medicinal product is apothecary reserved and the grant status.

§ 19. If a pharmacovigilconsultant of persons whom he / she visits receive information about the use of any of the medicinal products available, including the adverse effects of the medicinal product, the pharmaceutical consultants shall report this to the holder of : the marketing authorization for the medicinal product.

Chapter 7

Economic benefits

Economic benefits for the public

Representation

20. In the case of advertising and the professional information on medicinal products, no representation of or offered to the public in the form of payment of the spending on the payment of iris, travel, accommoding and soot.

Economic benefits for health professionals

Presents

§ 21. The marketing of a medicinal product shall not be used in advertising, nor in the interests of promoting the sale of a medicinal product or offered to health professionals in accordance with the case of the sale of a medicinal product. however, paragraph 1 2, section 23, section 25, section 26, section 29 and section 30.

Paragraph 2. The prohibition in paragraph 1. 1 does not include gifts of insignificant value when the present can be used in the recipient's profession, or given to the recipient's anniversary, for example, to a nomination or broadcast birthday.

Competitions

§ 22. It shall not be used for advertising purposes or, by the way, to promote the sale of a medicinal product in the name of competitions and the cost of the award of health professionals.

Merit benefits

-23. Regardless of the provision in section 21 (1). 1, it shall be permitted to pay for benefits from a health expert or a pharmacy where the remuneration is proportionate to the benefit. As a recipient of the remuneration, the basis for the remuneration of the Medicinal Board of Medicinal Products shall be provided, in accordance with its payment, in accordance with the basis of the remuneration.

Paragraph 2. Remuneration in accordance with paragraph 1. 1 may be granted only in the form of actual payment, not by means of offsetting, the transfer of naturai or other indirect means.

§ 24. Healthcare workers may not request or receive services which are in breach of section 21 (1). One, and section 22 and section 23.

Representation and sponsorship, etc.

§ 25. Regardless of the provision in section 21 (1). 1, is it permissible to provide or offer a health expert ;

1) representation, in the form of payment of the direct costs of ordering, travel, accommoding and soot. , in the case of advertising and technical information on medicinal products and

2) vocational information and training on medicinal products, in the form of payment of the direct costs of courses, and other professional and scientific activities to which health workers participate or hold.

Paragraph 2. The one in paragraph 1. 1, no. Paragraph 1 shall be kept at a reasonable level and be strictly limited to the main purpose of the meeting, including in time, in relation to that of advertising or professional activity. The presentation must include only health-care professionals.

Paragraph 3. In the event of commercial or professional activity abroad, only payment shall be made to those referred to in paragraph 1. 1 (1), in the case of non-compliance with the relevant services, the reasons for which are justified in substantive, practical or economic circumstances. These essential circumstances must be documented in the face of the Agency for the Evaluation of Medicinal Products.

Citizen meetings

SECTION 26. Regardless of the provision in section 21 (1). 1, it is permissible to sponsor meetings with technical information on medicinal products which are to be held by pharmacies to the public.

Paragraph 2. The sponsorship of the sponsorship referred to in paragraph .1 shall not exceed the direct costs of holding the activity in question, and representatives of the sponsorship ' s activities must not contribute to the holding.

Substance

§ 27. The participation of health-care workers in purely social or cultural events must not be paid.

Chapter 8

People employed in the sale of medicinal products outside pharmacies

§ 28. For holders of and employees in business approved to sell not for sale medicinal products or medicinal products for production animals, in accordance with the rules of the trade in the case of the products, Article 39, paragraph 39 of the medicinal product. Paragraph 60 (1) and 60 (2). The provisions of sections 11 to 13, sections 21 to 27, sections 21 and 30, shall apply when advertising or economic benefit relates to such medicinal products. However, the provisions shall apply only to employees employed by the said medicinal products.

Chapter 9

Cost-based rebates to apothecary and others

Requirements for discounts

§ 29. Regardless of the provision in section 21 (1). 1, if the discount is based on the cost lesions of the supplier, the rebate is permitted, and is a direct result of a purchase order shown by the recipient who differs from the standard conditions (cost justified) Discount.

Paragraph 2. The discount will have to be proportionate to the cost savings. A supplier must apply the same principles to calculation of discounts to recipients who display the same purchasing behavior.

Paragraph 3. No discounts shall be granted, as

1) are calculated on the basis of the purchase price of the supplier or calculated with the supplier ' s purchase price as an element in the bill,

2) are based on cost facilitations resulting from rationalizations within the supplier, or

3) are based on rebates provided by others to the supplier.

Paragraph 4. By way of derogation from paragraph 1 3, no. 3, the supplier can provide cost-based rebates based on cost relief in the form of discounts provided to the supplier of a service company that bids the distributor for distribution of medicinal products (e.g. a carrier). The discount from the service company must be based on a cost relief from this, as a result of the purchasing behaviour of the recipient, and the rebate must be proportionate to the cost of the cost.

Payment of discounts

-$30. The cost-based rebate may only be granted in the form of a reduction in the retail vendor purchase price. The discount must go to the direct buyer of the medicinal product and may be related to the delivery of the individual medicinal products or any batch of medicinal products.

Sign duty for dispensers for medicinal products

§ 31. Vendors must prepare and publish updated information about the access of pharmacists to obtain cost substantiated discounts as part of the pharmaceutical trade in pharmaceutical products. The information must be made available in clear and easily accessible manner on the supplier's website on the Internet.

Paragraph 2. It must be provided for in paragraph 1. Paragraph 1 shall indicate which delivery conditions the supplier considers to be standard conditions and under which discounts are not provided. The standard delivery terms shall contain basic information about the associated delivery terms, including information about the conditions of delivery frequency, quantum and time. It must also indicate which types of deviations in the purchase order in relation to the standard delivery conditions, the apothecary shall have to display in order to be able to obtain a discount.

Paragraph 3. Of the information, cf. paragraph 1, it shall also indicate which discounts a particular purchase order, or the individual changes thereto, which may be triggered by the maximum. The discount is specified as an amount or a percentage, and can be redone within a range.

Documentation for discounts on pharmacy reserved medicinal products

Suppliers

§ 32. The evidence of the valid cost-founded discounts on pharmacists reserved for medicinal products referred to in Article 71 b (b) of the medicinal product (s) of the medicinal product. 5, must hold for three years :

1) the information on the availability of discounts, which have been the sign, including details of during which time period the discounts have been in force ; and

2) invoices and credits issued no later than 30 days after the shipment has taken place, with information on how the discounts have been made together and calculated.

Pharmacists

§ 33. The evidence of cost-founded discounts on pharmacists reserved in pharmacists in accordance with the provisions of Article 71 (b) of the medicinal product (s) of the medicinal product are subject to the provisions of the medicinal product. 5, must hold for 3 years, or shall consist of invoices or credits issued not later than 30 days after the delivery has taken place, which shall include the following information :

1) Medioid name and number.

2) Price.

3) Discount Amount Received.

Leadership Declaration on Pharmaceuticals-Medicinal Products

§ 34. In the light of the data stored in Article 32, suppliers shall draw up a declaration of management in which it is declared,

1) the storage of documentation satisfies the conditions of section 32,

2) that the discounts have been provided in accordance with the information provided by the supplier and published information on the availability of cost-founded discounts, cf. § 31, as well as

3) that the discounts have been provided in accordance with the rules on cost-justified discounts in this notice, including the fact that the discounts provided are in relation to the cost execution.

Paragraph 2. The management declaration shall be drawn up for each calendar year and shall be submitted to the Medicinal Products Management Board no later than 1. April of the following calendar year.

Revision of discounts on pharmacy reserved medicinal products

$35. The documentation to be provided by suppliers shall be subject to the treatment of a state authorised or registered auditor to be provided under section 32.

Paragraph 2. The examination of the documents shall be subject to the examination of :

1) if the discounts have been granted in accordance with the information provided by the supplier and published information on access to cost-founded discounts, cf. § 31, as well as

2) whether or not the discounts have been granted in accordance with the rules on cost-reasoned discounts in this notice, including the amount of discounts involved in relation to the cost of the cost.

Paragraph 3. The auditor shall be based on his treatment in accordance with paragraph 1. 1 and 2 prepare a statement of assurance. The statement of assurance shall be replaced by the text of the certificate of assurance on the provision of a statement of assurance relating to the provision of cost-substantiated discounts by the pharmaceutical supplier. The statement of assurance shall be drawn up for each calendar year and shall be submitted to the Medicinal Products Management Board no later than 1. April of the following calendar year.

Pharmacies chains

§ 36. Cost-founded discounts on all medicinal products obtained by an association of pharmacists (apothecary chain) shall be added immediately, direct and uncut each of the pharmacies which are part of the association.

§ 37. Conferences of pharmacists must not request or receive discounts on apothecary reserved medicinal products which are not in conformity with the information on access to discounts as the supplier pursuant to Article 31 is obliged to draw up and shall make public or, in any case, contrary to the rules thereof in this notice.

Paragraph 2. Pharmaceuticals shall keep documentation (in the form of invoices or credits issued not later than 30 days after the delivery has taken place) for obtained and disclosed cost substantiated discounts on pharmacies reserved for medicinal products. The documentation must be kept for three years.

Chapter 10

Penalty and effective provisions

§ 38. Penis punished. The one who breached section 3, no. 3-5, section 4, section 5, section 5. One and two, section 6-8, section 10, paragraph 10. Paragraph 1, section 11, paragraph 11. 1-3 and 5, section 13, section 14 (4). One, two, four and five, section 16, section 17, paragraph 17. 2 and 3, section 18-20, section 21, paragraph. Paragraph 1, section 22, section 23, paragraph 23. 2, section 24, section 25 (4). 2 and 3, section 26 (4). 2, section 27 and section 29-37.

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

§ 39. The announcement shall enter into force on 1. March, 2013.

Paragraph 2. Publication no. 272 of 21. March 2007, on the advertising of medicinal products for medicinal products.

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Appendix 1

Statement of Assurance for Medicinal Provider Service Provider's Cost-based Discount Service Provider

Declaration by an independent auditor

NHS

Introduction

After agreement, we have completed the work actions that are listed below for the cost-reasoned discounts of the pharmaceutical suppliers, cf. § 35 in Bekendtstatement no. 272 of 21. March 2007, on advertising, etc. for medicinal products. Our declaration was only drawn up for the use of the pharmaceutical supplier and the Health Agency for the purpose referred to in this declaration.

The objective of the agreed work actions is that as auditors we carry out audit-like work actions concerning the pharmaceutical supplier ' s cost substantiated discounts required by the Ministry of Health and Preventative Ministry of the Ministry of the Ministry of the European Union, the 25-year audit instrument. -February 2008. We declare on the outcome of the audit-like work actions carried out below, under the "Actual Results" section.

The following work actions have been completed in accordance with the Danish audit standard of agreed work actions. The following work actions are neither audit nor review in accordance with Danish auditing standards in this respect, and we are alone on the actual results of the actions carried out, and thus do not express a conclusion. whether or not the pharmacovigilance supplier alone has provided cost-substantiated discounts within the applicable rules.

If we had carried out further work actions, revised or carried out review in accordance with Danish auditing standards, other circumstances may have been found and reported, and the declaration alone relates to the conditions specified ; below, it may not be extended to redirect the accounts of the pharmaceutical supplier as a whole.

Completed Actions

Our work has been carried out in accordance with the Danish auditing standard of agreed work actions.

Thus, our completed work actions can be summed up as follows :

1) We have at a random sample of the relevant annexes [ x comprise 10%. -However, at least 5 of them. and a maximum of 25 paragraph ] checked on the pharmaceutical supplier shall keep documentation, in the form of invoices and credits and the information on access to obtaining a discount on which there has been a sign with regard to cost substantiated discounts, cf. Section 32 of the promosection of advertising.

2) We have checked that the combination of the pharmaceutical supplier ' s cost substantiated discounts-as documented, cf. Section 32 of the advertising notice is consistent with the discounts which have been given to the apostles or the apothecary chains. We have at a random sample of x [ x represents 10%. -However, at least 5 of them. and not more than 25 (5), obtained confirmation from apothecary and apothecary chains on the rebates received during the calendar year.

3) We have at a random sample of x [ x represents 10%. -However, at least 5 of them. and no more than 25 paragraph ] checked whether the discounts provided are in accordance with the supplier ' s prepared and published information on access to cost-substantiated discounts. The check has been based on the supplier of the pharmaceutical supplier, storing documentation related to cost-reasoned discounts, including documentation in the form of the information on access to a discount, as has been signpost, and invoices and creditations, cf. The section 32 of the advertising notice. The checks shall therefore not include a review of the physical conditions lying on the basis of the documentation provided for in the records of the relevant discounts.

4) We have at a random sample of x [ x represents 10%. -However, at least 5 of them. and at the most 25 paragraph ] checked whether there is a clear basis for the assumption that discounts have been granted outside the framework of the rules in the section 29-31 and section 37 (3) of the advertising notice. 1. The check has been based on the supplier of the pharmaceutical supplier, storing documentation concerning cost-founded discounts, including documentation in the form of the information about access to obtaining a discount, as has been signpost, and invoices and creditations, cf. The section 32 of the advertising notice. The checks shall therefore not include a review of the physical conditions lying on the basis of the documentation provided for in the records of the relevant discounts.

Actual results

We have found the following conditions :

1) For example, no comments.

2) For example, we found that the combination of the pharmaceutical supplier's cost substantiated discounts-as documented, cf. Section 32 of the advertising notice is consistent with the discounts which have been given to the apostles or the apothecary chains. We have obtained confirmation from x apothecary and x apothecary chains of the discounts receipts of the calendar year.

3) For example, we have found that the sample was found that ...

4) For example, no comments.

(Actual results must include adequate errors and exceptions found.).

Date :

_____________________________

(State sautorist/registered auditor)

1) The commotion contains provisions that implement parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. 67.