askvity

What is MRP Pharma?

Published in Pharmaceutical Regulations 2 mins read

Based on the provided reference, MRP Pharma most likely refers to pharmaceutical products registered or undergoing registration via the Mutual Recognition Procedure (MRP). The Mutual Recognition Procedure is a process used to obtain marketing authorization for a medicinal product in multiple European Union (EU) member states, after it has already been authorized in one member state (the Reference Member State).

Here's a breakdown based on the context of the provided reference:

  • Mutual Recognition Procedure (MRP): A regulatory pathway for obtaining marketing authorization for pharmaceuticals in multiple EU member states.

  • Freyr Expertise (Reference): Offers regulatory consultation and strategic support during the development stage of medicinal products, including support related to Reference Medicinal Products (RMP) involved in the MRP.

Therefore, in the context of Freyr Expertise, MRP Pharma implicitly includes the regulatory processes and activities around:

  • Regulatory consultation and strategic support for medicinal product development related to MRP.
  • Support in selecting dissolution parameters and multimedia for performance of dissolution tests for both the test product and the Reference Medicinal Product (RMP) during MRP.

Essentially, the reference provided focuses on the regulatory support aspects related to the Mutual Recognition Procedure, and how a company like Freyr helps navigate the complexities when dealing with pharmaceuticals involved in MRP. Therefore, MRP Pharma isn't a specific thing, but rather refers to pharmaceuticals utilizing the Mutual Recognition Procedure for approval, and all the regulatory strategy and steps that involves.

Related Articles