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Good Manufacturing Practice requirements. Regulatory change

MedExpress Team

Medexpress

Published June 28, 2023 08:29

Good Manufacturing Practice requirements. Regulatory change - Header image
The Draft Regulation of the Minister of Health amending the Regulation on Good Manufacturing Practice requirements has been submitted for consultation.

The changes in the regulation are dictated by:

(1) the revision of the European Commission's Good Manufacturing Practice guidelines for investigational medicinal products for human use;

2) the adaptation of the requirements for the employment of a Qualified Person to the manufacturing carried out at the blood establishment;

3) the need to implement the European Commission's guidelines for importing medicinal products.

The project has been amended to include:

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