This Annex provides guidance on the certification by a Qualified Person (QP) and on
batch release within the European Union (EU) of medicinal products for human or
veterinary use holding a marketing authorisation (MA) or made for export. The
principles of this guidance also apply to investigational medicinal products (IMP) for
human use, subject to any difference in the legal provisions and more specific guidance
published by the European Commission.
The relevant legislative requirements are provided in Article 51 of Directive 2001/83/EC,
as amended, and in Article 55 of Directive 2001/82/EC. Notice is taken of the
arrangements referred to in Article 51(2) of Directive 2001/83/EC, as amended, and
Article 55(2) of Directive 2001/82/EC, e.g. Mutual Recognition Agreements (MRA).
Continue at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf
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