The following products are affected by the draft Act: Critical medicinal products, cf. Annex 1 to the draftOrder on medicinal products covered by mandatory stocks and reporting obligations for critical medicinalproducts

Draft Act amending the Act on medicinal products

(Mandatory stocks of critical medicinal products etc.)

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 Act proposes that anyone who places a critical medicinal product for human use used in the primarysector on the market in Denmark will be obliged to maintain a security stock of the medicinal product inquestion. The security stock must, as a rule, be located in Denmark, but a derogation may be granted for thesecurity stock to be located in another EU/EEA country.
It is also proposed that the Danish Medicines Agency be authorised to lay down detailed rules on the stockobligation, including on:
- which medicinal products are defined as critical;
- the companies to which the obligation applies;
- possibilities of derogation;
- the size of the stock and its calculation; and
- consumption of the stock in case of supply difficulties, including requirements for the use of forms.
It is also proposed that the Danish Medicines Agency may lay down detailed rules on the Agency’s controls ofthe stock obligation.
The enabling provision will be used to issue the Order on mandatory stocks and reporting obligations forcritical medicinal products and the Order on medicinal products covered by mandatory stocks and reportingobligations for critical medicinal products, which are notified at the same time as the draft Act amending the Acton medicinal products (Mandatory stocks of critical medicinal products etc.).