Appendix 1

Publication on the amendment of publication of the advertising of medicinal products for medicinal products

§ 1

Notice no. 198 of 27. February 2013 on the advertising of medicinal products for medicinal products is hereby amended as follows :

1. Inline ITREAS :

" ... pursuant to section 67, paragraph. 3, section 68, paragraph. Paragraph 1, section 70, paragraph 1. 1, section 71 b, paragraph 1. 3 and 5, and section 104 (3). 3 in Law No 506 of 20. April 2013 on medicinal products, and section 3 b (b). Paragraph 1, and section 72, paragraph 1. 2, in the case of apothecary, cf. Law Order no. 855 of 4. August 2008 shall be : "

2. I Section 21 (1). 1, is inserted after "§ 26" : ", section 27 a".

3. The following section 27 is inserted :

" Credit and return of pharmaceuticals from pharmacy to wholesaler

§ 27 a. Regardless of the provision in section 21 (1). 1 is allowed for price discreditation. For price credit, a company that has a permit in accordance with Article 39 (s) of the medicinal product is referred to in paragraph 1. 1, compensates an apothecary of the value of a stocked medicinal product which occurs if the pharmacist buying-in-sale price of the health inspector declared the apothecary shall be declared.

Paragraph 2. A company may not give credit to a medicinal product for 30 packs of a medicinal product in a given pacing size, pharmaceutical form and strength (that is to say, per item number) per 14-day price period.

§ 27 b. A pharmacy may no longer return 30 packs of a medicinal product in a given pacing size, pharmaceutical form and strength (that is to say, per item number) per 14-day price period for the retailer.

Paragraph 2. A pharmacy may only return the purchased and delivered medicinal packages to the wholesaler who delivered the pakings to the pharmacy, cf. Section 36 a in the notice on the distribution of medicinal products.

Paragraph 3. The provision in paragraph 1 shall be 1 shall not apply where :

1) the medicinal product has been revoked by the company which puts it on the market ; or

2) the marketing authorization for the medicinal product has been suspended or withdrawn by the Board of Health or the European Commission.

§ 27 c. A apothecary shall not ask for or receive services in violation of section 27 a. ` ;

4. I § 38, paragraph. 1, is inserted after "§ 27" : ", section 27 a, paragraph. 2, section 27 b, paragraph 1. 1, section 27 c `.

5. Appendix 1 the text of Annex 1 shall be replaced by this notice.

§ 2

The announcement shall enter into force on 5. June 2013.

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Appendix 1

' 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. 198 of 27. February 2013 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 :

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(State sautorist/registered auditor) '