Contacts

The laboratory organises and carries out a set of works on:

  • assessment of clinical and pharmacological section of the registration dossier of medicinal products as part of their state registration, confirming of state registration, amending the registration dossier, scheduling and carrying out clinical trials of medicinal products in the territory of the Republic of Belarus;
  • assessment of documents in modules 2, 4 and 5 of the registration dossier of medicinal products for human use within the framework of their registration (bringing the registration dossier of a medicinal product into compliance with the requirements of the Eurasian Economic Union), confirmation of registration (re-registration), amending the registration dossier in accordance with the requirements of the Eurasian Economic Union;
  • organisation and carrying out the analytical stage of studying bioequivalence of medicinal products;
  • pharmacovigilance;
  • organisation of examination of documents for scheduling clinical trials of medicinal products in the territory of the Republic of Belarus;
  • inspection of clinical trials of medicinal products for compliance with the requirements of Good clinical practice;
  • ensuring compliance of advertising of medicinal products, methods of medical care delivery, works and (or) services that make up medical activities, medical devices and medical equipment with advertising law before placement of such advertising in the mass media;
  • examination of documents and inspection of state health organisations for inclusion in the list of research centres that have the permission of the Ministry of Health of the Republic of Belarus to conduct clinical trials of medicinal products.

Our partners