Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

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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.

In general, these responsibilities relate to outsourcing and technical agreements, that require the MAH to perform certain specific tasks (e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.). These responsibilities are spread over the various chapters and annexes of the GMP guide, and are quite numerous.

This Reflection Paper seeks to provide clarity as to what the various responsibilities are and what they mean for MAHs at a practical level. In addition to the MAH responsibilities in the GMP guide, this paper also addresses the various legislative provisions (i.e. in European Directives and in other guidelines) which relate to GMP and which concern MAHs. Some of the responsibilities stated in the legislation (e.g. in Directives 2001/83/EC and 2001/82/EC) and in applicable guidelines are written in a way that they apply to marketing authorisation applicants, and they are included in this Reflection Paper because those provisions also convey responsibilities upon marketing authorisation holders in the postauthorisation phase.

It should be noted that, as indicated in Annex 16 of the GMP guide, the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH. It is also important to note that, while certain activities of an MAH may be delegated to a manufacturer or other party, the MAH retains the responsibilities which are outlined in this paper. The GMP guide also does not provide for reduced MAH responsibilities (or for the delegation of responsibilities) in 99 situations where the MAH and the manufacturer belong to the same overall group of companies but 100 where the two companies are different legal entities. There is no difference in the responsibilities that apply to the MAH in this situation relative to when the MAH and the manufacturer are from separate and unrelated companies.

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