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Mutual Recognition Procedure
Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended. Mutual Recognition Procedures can be carried out on products approved under Article 10(1), using Article 28(2).
Abridged applications for veterinary medicinal products in the EU are applications made under Article 13(1) of Directive 2001/82/EC, as amended. Mutual Recognition Procedures can be carried out on products approved under Article 13(1), using Article 32(2).
A Mutual Recognition Procedure (MRP) is used when your company wishes to market the same medicinal product in more than one country in the EU and where you already have a licence in at least one EU MS.
This MRP may be initiated either by the Health Authority (HA) or by the Applicant.
- A HA may start an MRP 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 and issue a licence before recognising the application.
- An applicant may instigate an MRP by notifying the Health Authority into which the first National Application is made ( Reference Member State or RMS) that they intend to submit the approved dossier into a number of other Member States ( Concerned Member States or CMSs) following licence approval.
- Ivowen Limited has a wealth of experience in preparing and submitting dossiers using the MRP system.
- Ivowen Limited can manage all htmlects of the procedure independently or in liaison with your own Regulatory Affairs department.
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