News about GMP/cGMP

20.05.2016

MRA EU/Switzerland to be amended

The European Commission is about to adopt an amendment to the Mutual Recognition Agreement (MRA) with Switzerland. The amendment would cover the mutual recognition of GMP inspections in third countries as well as products manufactured outside Switzerland.

 

In June 2015 Switzerland proposed amendments to Chapter 15 of the MRA which would allow the mutual recognition of GMP inspections in third countries. Switzerland suggested as well alignment of the material scope of the Chapter 15 with the scope of the MRA Agreement to cover also products manufactured outside Switzerland.

After discussions with the Commission services (SANTE, TRADE) on several occasions, DG SANTE advised DG TRADE to accept the Swiss proposal to recognize the outcomes of GMP inspections in third countries as this would allow better allocation of inspection resources. As regards the proposed alignment of the scope of Chapter 15 with the scope of MRA, DG SANTE advised DG TRADE to accept it only on the condition that a medicinal product manufactured outside Switzerland and imported into the EU from Switzerland can be retested in the EU in case it was not tested on the Swiss territory. Similar guarantee is provided in ACAA with Israel which applies also to products manufactured in third countries.

DG TRADE is currently preparing an EU-Switzerland Joint Committee Decision proposing mentioned amendments to the Chapter 15 of the EU-Switzerland MRA. The decision, before being presented to the Joint Committee, has to be adopted by the Commission.


Source:

Document pharm713 of the 76th Meeting of the Pharmaceutical Committee on 28 April 2016

 



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