Parallel distribution means the distribution of a centrally authorised medicinal product from one Member State to another independently of the marketing authorisation.
The European Medicines Agency (EMA) confirms receipt of notifications about parallel distribution. This facilitates the surveillance of the market and the monitoring of compliance with the provisions on parallel distribution established in EU law.
The parallel distributor thus does not receive a separate marketing authorisation, but instead receives a confirmation from EMA, stating that parallel distribution of the product is now permitted along with information about which types of packages the permission covers.
EMA notifies the Danish Health and Medicines Authority when a company has been granted permission to distribute packages of a centrally authorised medicinal product in parallel, stating the medicinal product concerned and the packages covered by the permission.
The Danish Health and Medicines Authority then makes it possible for the company to see the product in DKMAnet so that the company can notify their authorised packages to Medicine Prices via DKMAnet.
Parallel distribution of products linked to risk management plans
If a company wants to distribute in parallel a medicinal product which is linked to a risk management plan, cf. Article 127a of Directive 2001/83/EC: conditions or restrictions with regard to the safe and effective use of the medicinal product concerned, it is the marketing authorisation holder who is legally obliged to ensure continuous compliance with the provisions laid down in Annex II of the marketing authorisation.
The parallel distributor must ensure and, to the extent necessary, contribute to ensuring that the provisions laid down in Annex II of the marketing authorisation have been fulfilled before the product is placed on the market.
For further information, please see the EMA website:
European Medicines Agency - parallel distribution of human products
European Medicines Agency - parallel distribution of veterinary products