MUTUAL RECOGNITION PROCEDURE | PROCESS FLOW CHART

The mutual recognition procedure and decentralised procedure must be used for applications for marketing authorisation for medicinal products in more than one Member State. The requirements of submitting an application are described in section 3 and 4. Once the procedure has been used, all variations to these medicinal products must use the procedure foreseen in the Variations Regulation.

The mutual recognition procedure and decentralised procedure must be used for applications for marketing authorisation for medicinal products in more than one Member State. The requirements of submitting an application are described in section 3 and 4. Once the procedure has been used, all variations to these medicinal products must use the procedure foreseen in the Variations Regulation.
June 13, 2023

The mutual recognition procedure (MRP) is the European Union-wide procedure through which a granted marketing authorisation of a medicine in one European Union Member State is recognised in other EU countries.

The legal provisions covering the mutual recognition procedure for human medicinal products are contained in Directive 2001/83/EC.

The process of a MRP is quite challenging and there are a lot of timelines to be kept.

We have summarized all MRP steps in this flow chart for you to download and keep always at hand. You can view it here:

Infografia MRP ASPHALION.

For further information, you can contact us at: info@asphalion.com

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