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Decentralised Procedure
Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended. The Decentralised Procedure can be used to get more than one MA in the EU at the same time, using Article 28(3).
Abridged applications for veterinary medicinal products in the EU are applications made under Article 13(1) of Directive 2001/82/EC, as amended. Decentralised Procedures can be carried out on products approved under Article 13(1), using Article 32(3).
A Decentralised Procedure (DCP) is used when your company wishes to market the same medicinal product in more than one country in the EU and where you do not already have a licence in any EU MS.
This DCP may be initiated either by the Health Authority (HA) or by the Applicant.
- A HA may start a DCP when an application for the same product is submitted in more than one EU member state at the same time. In this case, one of the Member States suspends assessment of the application and waits for the other Member State to complete assessment before recognising the application.
- An applicant may instigate DCP by notifying the Health Authority that they wish to use them as Reference Member State (or RMS) and that they intend to submit an identical into a number of other Member States (Concerned Member States or CMSs) at the same time.
- Ivowen Limited has a wealth of experience in preparing and submitting dossiers using the DCP system.
- Ivowen Limited can manage all htmlects of the procedure independently or in liaison with your own Regulatory Affairs department. |
