Law on the amendment of the law on medicinal products, the apothecary and the tissue slots 1)

(Strength of action against illegal drugs and others)

We, by God's grace, the Queen of the Danes, do our thing.

The parliament has adopted the following law, and we know that the following law has been approved by Parliament's consent :

§ 1

Law no. 1180 of 12. In December 2005 on medicinal products, as amended by Section 81 of Law No 538 of eight. June 2006 and section 1 of the Law No 1557 of 20. December 2006, the following changes are made :

1. I footnote shall be deleted by the law ' by ' no later `, and after ' (EU Official Journal 2004) L 136, s. The following shall be inserted : ' and at the latest by Regulation (EC) No (EC) No (EC) No 1394/2007 of 13. November 2007 on medicinal products for advanced therapies and amending Directive 2001 /83/EC and Regulation (EC) No 19. 726/2004 (EU Official Journal, 2007 # L 324, s.121) ".

2. The following section 4 is inserted :

" § 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. ` ;

3. I § 30, 1. pkt., the words ' Danish Food Research ` shall be replaced by ' the Veterinary Institute at Denmark ' s Technical University ` ;

4. the following title shall be inserted after section 43 " Inspection and inspection " :

" § 43 a. The holder of a permit after Section 7 or Section 39 (3). 1, notify the medical board of doctors, dentists and pharmacists who are associated with the establishment.

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.

Falsied medicinal products

§ 43 (b). No production, import, export, storage, negotiation or the supply of counterfeit medicinal products shall be prohibited.

Paragraph 2. The holder of a permit after Section 7 and section 39 (3). 1, shall immediately report findings in the establishment of counterfeit medicinal products to the Medicinal Products Agency. For holders of a permit in accordance with section 7 and holders of a licence for the manufacture of medicinal products, the obligation to report shall also be subject to a find outside their activities to which they are informed.

§ 43 c. The governing board may, on suspicion of the discovery of a falsified medicinal product, to disclose all information on the discovery of a falsified medicinal product to the marketing authorization holder for the specific named medicinal product, as the medicinal product falsified. appear to be identical to. "

5. Section 44 (2). ONE, TWO. pkt., is hereby repealed and the following shall be inserted :

' The governing board shall also check that the medicinal products, a company with a permit in accordance with paragraph 39, are checked. 1, reseller or distributor is subject to a marketing authorisation, cf. section 7, or permission after sections, 29, 31 or 32. The governing board shall, moreover, control compliance with § 40 a, paragraph 1. 3, and section 43 b. "

6. I Section 44 (2). TWO, THREE. pkt., inserted after ' information ` shall be inserted : ' and materials `.

7. After section 45, pasted before heading " Prohibition of negotiation and delivery ' :

" § 45 a. The Minister for Health and Prevention may, in consultation with the person concerned, lay down rules that representatives of authorities belonging to the relevant ministers ' rescheum, on behalf of the Medicinal Board, may carry out checks for purposes of this purpose ; to ensure the lawful distribution of medicinal products. ` ;

8. After section 46, pasted before heading " Prohibition of manufacture and importation ' :

" § 46 a. The governing board 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. `

9. § 49 ITREAS :

" § 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. ` ;

10. § 77, paragraph. 2, ITREAS :

" Stop. 2 The minister for health and prevention may lay down rules on notification under paragraph 1. 1, including a minimum limit for the changes to apothecary content of medicinal products for human beings, and the requirements for notification, including notification of notification by notification of electronic means. ` ;

11. Section 78 (1). 4, ITREAS :

" Stop. 4 The Minister for Health and Prevention may lay down detailed rules for notification to the Medicinal Agency (FDA) under paragraph 1. 1-3, including a minimum limit for the changes to pharmacies of pharmacies for medicinal products, and the requirements for notification, including notification of notification by notification of electronic means. `

12. I section 103 (3). 1, no. 6, the following shall be inserted after ' approval of ' : ' and the charge for checking the '.

13. I § 104, paragraph 1. 1, no. 1, the words ' section 7, ` and ' section 39 (4) are deleted ; The following shall be added : 1 or 2 ` and after ' section 43 ` shall be inserted : " § 43 a, stk.1, and § 43 b (3) (b). TWO, "

14. I § 104 inserted after paragraph 1. 1 as new paragraph :

" Stop. 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, section 39 (4). 1 or 2, or § 43 (b) (b) ; 1 or fail to comply with an injunction issued in accordance with section 46 a. ` ;

§ 2

In the case of apothecary, cf. Law Order no. 657 of 28. July 1995, as amended in particular by Law No 1. 1042 of 23. In December 1998 and at the latest in paragraph 2 of the Act 1557 of 20. December 2006, the following changes are made :

1. I Section 3, paragraph 3. 2, in the words ' consent ' shall be replaced by ' authorisation `.

2. I Section 3, paragraph 3. 2 and 3 , in the words ' section 39 (4), 1 or 2, "to :", section 7 or section 39, paragraph 1. 1, "

3. I § 3 pasted as paragraph FOUR :

" Stop. 4 Permissions under paragraph 1. 2 or 3 may be published on the Homepage Home Page. `

4. I Section 11 (1). 1, pasted as no. 13 :

" 13) Inversive reporting to the Medicinal Products Agency of the Drug Pharmacy found in the pharmacy of falsified medicinal products, cf. Section 43 (b) in the law on medicinal products. ` ;

5. I Section 65 (2). 1, is inserted after 1. Act. :

§ 3

Law no. 273 of 1. April 2006 on the requirements for quality and safety in the handling of human tissues and cells (tissue slop) is amended as follows :

1. I footnote the title of the law shall be inserted after ' (the Official Journal of 2004, no. L 102, s. (48) " and parts of Directive 2001 /83/EC of the European Parliament and of the Council on the establishment of a Community code relating to medicinal products for human use in the Official Journal of the European Communities (EC Official Journal 2001). L 311, s. Regulation (67), as amended by Regulation (EC) No later of the European Parliament and of the Council 1394/2007 of 13. November 2007 on medicinal products for advanced therapies and amending Directive 2001 /83/EC and Regulation (EC) No 19. 726/2004 (EU Official Journal, 2007 # L 324, s.121) ".

2. I Section 2 (2). 1, pasted as Act 2. :

3. The following section 11 is inserted :

" Chapter 4 a

Sales and delivery of hospital-produced medicinal products for advanced therapy

§ 11 a. Advanced therapy medicinal products made in a hospital in Denmark specially adapted to a particular patient after the individual display of a doctor, cf. the provisions of Article 4 of the medicinal product, section 4 (a), must be sold or delivered only for the use of patient care after the Medicinal Board has issued an extradition authorisation to the practising physician.

Paragraph 2. The governing board may assign conditions to the permit and may revoke the authorization if these conditions are not met or there are serious problems with the quality, safety or efficuse of the medicinal product, including serious adverse reactions. ` ;

4. Section 13 (1). 1, ITREAS :

5. I Section 13 (1). 2, ' serious adverse reactions ` shall be replaced by : ' serious adverse reactions to the donor '.

6. I Section 14, paragraph 14. 1, is inserted after no 2 as new number :

" 3) The sale or supply of hospital-inducing medicinal products to advanced therapy. `

7. I § 17, paragraph 1. 2, ' serious adverse reactions ` shall be replaced by ' serious adverse reactions '.

8. I Section 21 (1). 1, no. 1, is inserted after "§ 5," : "§ 11 a, stk.1,".

§ 4

The law shall enter into force on 1. July 2008.

§ 5

The law does not apply to Faeroe Islands and Greenland

1) The law provides for the implementation of a Community code of medicinal products for human use (EC Official Journal 2001) by Directive 2001 /83/EC of the European Parliament and of the Council. L 311 s. Regulation (67), as amended by Regulation (EC) No later of the European Parliament and of the Council 1394/2007 of 13. November 2007 on medicinal products for advanced therapies and amending Directive 2001 /83/EC and Regulation (EC) No 19. 726/2004 (EU Official Journal, 2007 # L 324, s.121).