The Draft Regulation of the Minister of Health amending the Regulation on Good Manufacturing Practice requirements has been submitted for consultation.
Good Manufacturing Practice requirements. Regulatory change
Published June 28, 2023 08:29
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:
1) Replacement of the existing regulations contained in Annex 13 in Annex 5 to the Order of the Minister of Health of November 9, 2015 on Good Manufacturing Practice requirements with the European Commission guidelines entitled "Good Manufacturing Practice for Investigational Medicinal Products for Human Use". "Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014" (Brussels, 8.12.2017 C(2017) 8179 final) only for investigational medicinal products for human use;
2) Alignment of the requirement in Annex 14 in Annex 5 to the Regulation of November 9, 2015 on Good Manufacturing Practice requirements with the European Commission's guideline "Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma" (Brussels, SANCO/C8/AM/an D(2010) 380358);
3) Implementation of the European Commission's guidelines entitled: The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 21: Importation of medicinal products, issued by the European Commission Brussels, 16.2.2022 C(2022) 843 final by introducing a new Annex 21 "Importation of medicinal products" in Annex 5 to the Regulation of the Minister of Health of November 9, 2015 on the requirements of Good Manufacturing Practice;
4) Implementation of the European Commission guidelines entitled "EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. "EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, issued by the European Commission (Brussels, 16.2.2022 C(2022) 843 final)" regarding the import of investigational medicinal products.
Implementation of the aforementioned requirements will ensure that the conditions for performing activities related to the manufacture and import of medicinal products in the Republic of Poland and in other European Union member states will be identical, which will allow mutual recognition of inspections of manufacturing conditions and Good Manufacturing Practice certificates for medicinal products.
Source: RCL
