Parallel distribution
HumanVeterinaryRegulatory and procedural guidanceParallel distribution
This content applies to human and veterinary medicines.
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 European Union, 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.
Using the IRIS platform
On 11 February 2019, EMA launched a secure online platform for submitting and managing parallel distribution notifications, called the IRIS platform:
EMA first launched IRIS in 2018 to manage orphan designation applications, and is expanding the system to handle other procedures beginning with parallel distribution.
IRIS reduces the time needed to prepare and submit notifications and ensures better data quality through integration with other EMA systems. Users can check the status of applications from any device and receive automatic notifications when the status changes.
Parallel distributors need to use IRIS to manage their ‘initial notification’, ‘safety update’ and ‘update of the status (dormancy/withdrawal)' procedures.
For guidance on how to use IRISfor parallel distribution notifications, see:
Public register of parallel distribution notices
The public register of parallel distribution notices provides up-to-date information on parallel distribution notices currently held by EMA.
Parallel distribution notices are notice letters which parallel distributors must obtain from EMA before placing a product on the market.
The register has 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.