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Good Manufacturing Practice requirements. Regulatory change

MedExpress Team


Published June 28, 2023 08:29

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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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