Ordinance Amending The Ordinance Concerning The Distribution Of Medicinal Products

Original Language Title: Bekendtgørelse om ændring af bekendtgørelse om distribution af lægemidler

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Ordinance amending the Ordinance concerning the distribution of medicinal products

§ 1

In executive order No. of 12 1243. December 2005 on the distribution of medicinal products, as amended by Decree No. 186 of 22. February 2007, shall be amended as follows:

1. section 4 (1) (8). 1 and 2, shall be replaced by the following: ' 1) have an adequate number of staff, who meets the requirements set out in §§ 13-14, and

2) have rooms and equipment that satisfies the requirements set out in §§ 15-18. '

2. In article 13, paragraph 1, the following is inserted as a 3. item:

» The responsible person must have his time in the company of an adequately taking into account the activity of the company or pharmacist. '

3. In article 20, paragraph 1, the words ' without prejudice to article. However, paragraph 2-4 ' to: ' without prejudice to article. However, paragraph 2-6 '.

4. In section 20 shall be inserted after paragraph 3 as new pieces: ' (4). In addition to those referred to in paragraph 1, the recipients can medical samples with the Danish Medicines Agency's permission, by the marketing authorisation holder or his representative, shall be handed over to doctors, dentists and veterinarians, see. notice of distribution of samples of medicinal products. The Danish Medicines Agency may determine the conditions of the permission.

(5). In addition to those referred to in paragraph 1, the recipients can radiopharmaceuticals supplied to nuclear medicine departments at hospitals, see. notice of radiopharmaceuticals and the Executive order on handling, etc. of radioactive medicines at hospitals. '

Paragraph 4 becomes paragraph 6.

5. Under section 26 shall be inserted:

» Counterfeit drugs

section 26 (a). Wholesalers and pharmacies to ensure that medicinal products which are or can be forged, be kept separate from other drugs. Medicinal products must also be marked, so it is clear that they are not for sale or dispensing. '

6. In article 27 paragraph 4 is inserted:

' (4). The provision in paragraph 1 shall apply mutatis mutandis in the extradition of drug samples to doctors, dentists and veterinarians, is happening on behalf of the holder of the marketing authorisation referred to in article 6. Article 20, paragraph 4. '

§ 2

The notice shall enter into force on 25 July. November 2008.
The Ministry of health and prevention, 12. November 2008 Jakob Axel Nielsen/Paul Schüder

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