The following products are affected by the draft Act:

Critical medicinal products, cf. Annex 1 to the draft Order on medicinal products covered by mandatory stocksand reporting obligations for critical medicinal products

Order on mandatory stocks and reporting obligations for critical medicinal products

The following products are affected by the draft Act:

Critical medicinal products, cf. Annex 1 to the draft Order on medicinal products covered by mandatory stocksand reporting obligations for critical medicinal products
The following groups are affected by the draft Act:
Marketing authorisation holders in Denmark, holders of parallel import authorisations and companiesdistributing medicinal products in parallel to Denmark after notifying the European Medicines Agency.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Communitycode relating to medicinal products for human use, OJ 2001 L 311, p. 67, as amended, inter alia, by Directive2010/84/EU of 15 December 2010, OJ 2010 L 348, p. 74, Directive 2011/62/EU of 8 June 2011, OJ 2011 L174, p. 74, and Directive 2012/26/EU of 25 October 2012, OJ 2012 L 299, p. 1.
Implementation of parts of Directive 2001/83/EC of the European Parliament and of the Council of 6 November2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67, asamended, inter alia, by Directive 2010/84/EU of 15 December 2010, OJ 2010 L 348, p. 74, Directive2011/62/EU of 8 June 2011, OJ 2011 L 174, p. 74, and Directive 2012/26/EU of 25 October 2012, OJ 2012 L299, p. 1.
The draft Order, which is to be seen in the context of the Order on medicinal products covered by mandatorystocks and reporting obligations for critical medicinal products, will implement the enabling provisions inSection 75(4) and Section 75 b(2) of the draft Act amending the Act on medicinal products (Mandatory stocksof critical medicinal products etc.).
Order on mandatory stocks and reporting obligations for critical medicinal products lays down
- which companies are subject to the obligation to maintain security stocks of critical medicinal products;
- possibilities of derogation;
- the size of the stock and its calculation;
- consumption of the stock in case of supply difficulties, including requirements for the use of forms;
- reporting obligations for the stock of critical medicinal products, including frequency of reporting; and
- provisions on the Danish Medicines Agency’s controls of the stock obligation.