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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