Appendix 1

Appendix 2

Publication of the item numbers for medicinal products 1)

In accordance with section 83 (2), 2, and section 104 (3). Three, in the law. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 534 of 17. June 2008 shall be determined :

§ 1. Each individual medicinal product, the strength and the size of an approved medicinal product must be given a unique item number, cf. However, section 7.

Paragraph 2. A pharmacogalification must be provided with a new item number if the medicinal product changes its name.

Paragraph 3. A pharmacovigilance must be replaced by a new item, in the case of a change to a new holder of the marketing authorization, or if the marketing authorization holder changes his name.

Paragraph 4. The requirement for new item number in accordance with paragraph 1. 3 shall not apply where the new holder of the marketing authorisation is another undertaking within the same group, and the name of the medicinal product and the name of the marketing authorization holder shall remain unchanged. However, the only indication of the company form in the name of the marketing authorization holder shall not, however, result in a change in the item number.

Paragraph 5. The provisions of paragraph 1. 2 and 3 shall not apply to medicinal products which have a product number, but have never been placed on the market.

§ 2. An assigned item number may be used only for one marketing authorization number.

§ 3. A multipacking, that is, a packaging consisting of two or more packs of an approved medicinal product (subpacks), which are also negotiated individually, shall be considered by a separate item number.

Paragraph 2. The individual subpacks in a multigasket must be provided with a separate item number. If the sub-pacts are part of multiple packs, they must have a separate item number for each size of multi-packing.

§ 4. In the case of a medicinal product for a medicinal product for animals consisting of several inner packs, which in themselves provide the medicinal product with sufficient protection against external influences (a stork), the insides of the core may have a separate item number.

Paragraph 2. The provision in paragraph 1 shall be 1 applies only to medicinal products approved for :

§ 5. Magistrelle medicinal products must be provided with the item number if they are listed in Annexes 1 or 2.

§ 6. The item number shall be subject to the pharmaceutical packaging in such a way that it cannot be removed.

§ 7. The product number of approved medicinal products shall be requested from the Medicinal Products Agency or an institution which is empowered by the Medicinal Products Agency for the award of the item numbers. Information on where the item numbers can be obtained may be obtained by contacting the Medicinal Products Agency.

Paragraph 2. No later than 14 days before an alert number is taken (the packing is placed on the market), this shall be reported to the Medicinal Board of Medicinal Products. This also applies to the item number for a part or inner gasket. The report shall be presented on a form which is available by way of a call to the Medicinal Board.

§ 8. The announcement does not apply to medicinal products covered by

§ 9. In exceptional cases, the governing board may dispense with the provisions of this notice in exceptional cases and in terms of conditions laid down in each individual case.

§ 10. The penalty shall be penalised by the penalty which is in breach of section 1 to 6 or section 7 (7). 2.

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

§ 11. The announcement shall enter into force on 3. July, 2009.

Paragraph 2. Publication no. 961 of 26. October 2000 on the goods numbers for medicinal products are hereby repealed.

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Appendix 1

Magistrelle medicinal products for human use which, in accordance with section 5, shall be provided with item number ;

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Appendix 2

Magistrelle medicinal products for veterinary use, which shall, in accordance with section 5, be provided with item number ;

1) The announcement has, as a draft, been notified in accordance with Directive 98 /34/EC of the European Parliament and of the Council (the Information Directive), as amended by Directive 98 /48/EC.