Contacts

The laboratory carries out and performs:

  • as part of a complex of preliminary technical works that precede the state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus:
    • specialised expert examination of the relevant sections of the documents for compliance of the medicinal product with the requirements for safety and quality, considering their pharmaceutical characteristics;
    • testing of procedures for quality control of medicinal products in the cases stipulated by the laws of the Republic of Belarus;
    • carrying out quality control of medicinal products with the use of the claimed procedures when conducting clinical trials;
    • verification of the accuracy of reproducing quality control procedures at the address of the manufacturer of the medicinal product or drug substance that performs quality control in cases stipulated by the laws;
  • quality control of medicinal products on certain parameters in cases stipulated by the laws;
  • preparation for publication and updating of the State Pharmacopoeia of the Republic of Belarus;
  • creation and maintenance of an electronic archive of regulatory documents on quality control of medicinal products used by testing laboratories of state healthcare organisations accredited in the accreditation system of the Republic of Belarus to perform tasks on quality control of medicinal products registered in the Republic of Belarus before sale and medicinal products in circulation in the territory of the Republic of Belarus;
  • development of draft regulatory legal acts within the competence of the laboratory;
  • for the purpose of the registration of medicinal products for human use in order to create a common market of medicinal products within the Eurasian economic Union as well for the purpose of procedures related to the registration of medicinal products for human use:
    • specialised examination of the relevant sections of documents for compliance of a medicinal product with safety and quality requirements, taking into account their pharmaceutical characteristics within registration, confirmation of registration (re-registration) of medicinal products, amendments to the registration dossier for a previously registered medicinal product;
    • laboratory tests for compliance with the requirements of the regulatory document for quality and reproducibility of the claimed quality control procedures;
  • participation in the development of the Pharmacopoeia of the Eurasian economic Union.

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