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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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Publication concerning the amendment of the notification of the distribution of medicinal products

§ 1

Notice no. 1243 of 12. In December 2005, on the distribution of medicinal products, as amended by publication No 2 ; 186 of 22. February 2007, the following changes are made :

1. Section 4 (4). 1, no. 1 and 2, ITREAS :

" 1) Councilor over a sufficient staff meeting the requirements of section 13-14 ; and

2) have rooms and equipment meeting the requirements of section 15 -18. ` ;

2. I Section 13 (1). 1, pasted as Three. Point. :

"The person responsible must be responsible for his time in a sufficient amount, taking into account the activity of the company or at the pharmacy."

3. I Section 20 (2). 1, is changed " cf. however, paragraph 1 2-4 "to :" cf. however, paragraph 1 2-6.

4. I § 20 inserted after paragraph 1. 3 as new slices :

" Stop. 4. In addition to the provisions of paragraph 1, 1 the beneficiaries may, in accordance with the authorisation of the medicinal product of the medicinal product, of the marketing authorization holder or his representative, the medicinal product shall be extradite to doctors, dentists and veterinarians, cf. notification of the supply of medicinal products for medicinal products. The governing board may lay down terms for the authorisation.

Paragraph 5. In addition to the provisions of paragraph 1, 1 mentioned recipients may be supplied to nuclear medical facilities in hospitals in hospitals, cf. the notification of radioactive medicinal products and the notification of handling and so forth of radioactive medicinal products in hospitals. ` ;

Paragraph 4 becomes paragraph 4. 6.

5. After paragraph 26 is inserted :

" Falsished medicinal products

§ 26 A. Wholesalers and pharmacies shall ensure that medicinal products that are or may be falsified are kept separate from other medicinal products. In addition, the medicinal products must be labelled, so that they are not for sale or extradition. '

6. I § 27 pasted as paragraph FOUR :

" Stop. 4. The provision in paragraph 1 shall be 1 shall apply mutatis mutandis by the supply of medicinal samples to doctors, dentists and veterinarians, which shall be made on behalf of the marketing authorization holder, cf. Section 20 (2). 4. "

§ 2

The announcement will enter into force on the 25th. November, 2008.

The Ministry of Health and Prevention, the 12th. November 2008 Jakob Axel Nielsen / Paul Schüder