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.
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 IRIS for parallel distribution notifications, see:
- Frequently asked questions about parallel distribution
- IRIS quick guide to registration
- IRIS guide to the portal for parallel distribution users
To enable this change and EMA's Relocation to Amsterdam in March 2019, EMA will not be able to receive annual update submissions from 1 February to 30 April 2019. EMA strongly advises companies wishing to re-activate dormant products or product presentations to submit their notifications before the freeze period. To re-activate a product during the freeze period or for further questions, please contact firstname.lastname@example.org for guidance.
In addition, EMA will not post physical notice letters from 15 February to 1 April 2019. Following this period, stakeholders will be able to request individual signed notice letters if required.
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.