Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

EMA/457570/2019

Jenson R+ Limited can facilitate Marketing Authorisation Holder services both in the UK and Europe. We take these responsibilities seriously. This consultation paper sets out where the responsibilities lies with the MAH. At this stage this is consultation but often indicates the Commission’s thinking for the future. This is your chance along with ourselves to comment on these proposals.

End of consultation – deadline for comments 17 April 2020.

EMA/457570/2019

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) guide to GMP (hereafter referred to as the ‘GMP guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.

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Janet Worrell