The implementation of directive 2011/62/EU of 8 June 2011 on falsified medicines implies changes to company authorisations.
At the same time, the concept of wholesale distribution becomes broader and will in future also cover distribution (purchase and sale) of medicinal products, whereas before the physical handling of medicinal products was the pivotal element in the granting of wholesale dealer's authorisations (GDP).
In continuation of the bill (L32) on amendment of the Danish Medicines Act, etc. published on 11 October 2012, a number of draft executive orders were submitted for consultation to come into force on 1 January 2013. With regard to company authorisations, the folowing executive orders are relevant:
- Executive order on manufacture and import of medicinal products and intermediate products (GMP) – Danish title: "Bekendtgørelse om fremstilling og indførsel af lægemidler og mellemprodukter (GMP)".
- Executive order on the distribution of medicinal products – Danish title: "Bekendtgørelse om distribution af lægemidler (GDP)".
- Executive order on manufacture, import and distribution of active substances for manufacture of medicinal products (API) – Danish title: "Bekendtgørelse om fremstilling, indførsel og distribution af aktive stoffer til fremstilling af lægemidler (API)".
The executive order on manufacture, importation and distribution of active substances for manufacture of medicinal products (API) is entirely new.
The new executive orders will, among other things, have the following significant implications for companies active in the pharmaceutical area in Denmark:
- After 1 January 2013, brokers of human and veterinary medicinal products must register with the Danish Health and Medicines Authority.
- After 1 January 2013, manufacturers, importers and distributors of APIs intended to be used in human medicinal products with a marketing authorisation must register with the Danish Health and Medicines Authority.
- Wholesale distribution (purchase and sale) of human and veterinary medicinal products is now defined as a wholesale distribution activity and therefore requires a wholesale dealer's authorisation.
Brokering is defined as all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution. Brokering does not include physical handling, but consists of negotiating independently and on behalf of another legal or natural person
Companies in Denmark that started their brokering of medicinal products and manufacture, import and distribution of APIs before 1 January 2013 must register with the Danish Health and Medicines Authority by 1 March 2013.
Registration of brokers
Registration of manufacturer, importer or distributor of active substance (used in medicinal products for human use)
Please see our notice in Danish here, which will be available in English in the new year.