Parallel distribution is the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. The task of the European Medicines Agency (EMA) is to check compliance of products distributed in parallel with the conditions laid down in Community legislation on medicinal products and in the marketing authorisation of the product.
On 20 May 2004, notifications of parallel distribution of centrally authorised medicinal products became mandatory throughout the community, in accordance with Article 57(1)(o) of Regulation (EC) No 726/2004. Since that date, all medicinal products on the market in the EU distributed in parallel have to comply with the requirements of the EMA notification procedure for parallel distribution. Similarly, the parallel distribution of centrally authorised medicinal products on the market for which a notification has not been applied for must comply with those requirements.
For more information on parallel distribution and the notification procedure, see Frequently asked questions about parallel distribution.
On 17 December, the Executive Director signed a Decision on a 1-year pilot initiative for fee reductions for notifications of parallel distribution in the Maltese language.
For further information, please see the Fees payable to the European Medicines Agency page.
Public register of parallel distribution notices
The public register of parallel distribution notices, launched in July 2015, provides up-to-date information on parallel distribution notices currently held by the EMA.
Parallel distribution notices are notice letters which parallel distributors must obtain from EMA before placing a product on the market.
The register was created in consultation with parallel distribution stakeholders with the following objectives:
- to promote transparency about parallel distribution notices;
- to facilitate the identification of parallel distribution notices held by the Agency;
- to increase information available to national competent authorities, marketing-authorisation holders, parallel distributors and wholesalers;
- to facilitate the effective supervision of parallel trade.
The Agency issues approximately 2,500 parallel distribution notices each year. The parallel distribution register will be updated monthly by the Agency.
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Nikolaus Kriz - Head of parallel distribution and certificates
Tel. +44 (0)20 3660 7016