4. Documentation:

• Permission to release the medicinal product in the country of origin;
• Permission to label the medicinal product in the country of manufacture;
• Permission to advertise the medicinal product in the manufacturing country;
• Details of registration procedures in other countries.

5. Manufacturer information:

• The name of the manufacturing company;
• Manufacturer's address;
• Contact Information.

6. Information about the applicant:

• Name of the applicant company;
• Applicant's address;
• Contact Information.
• Details of registration procedures in other countries;

7. Results of studies on the safety and efficacy of the medicinal product:

• Results of studies on safety and efficacy;
• Information about adverse drug reactions.

After the submission of full documentation for the registration of a medicinal product in the EAEU, it is registered and a permit is issued for its sale in the territory of the EAEU member countries.

Certification of a production site according to GMP (Good Manufacturing Practice) requirements is a process of assessing and confirming the compliance of production processes and conditions for the production of medical products (drugs, medical devices, food additives) with international GMP standards.

GMP certification of a manufacturing site includes verification of compliance with the requirements established in the governing documents (for example, European Pharmacopoeia, FDA, PIC/S), as well as verification of compliance with legal and regulatory requirements in the country where the site is located.

Certification is carried out by independent experts or organizations accredited to conduct such assessments. After passing the certification check, the production site is issued a GMP certificate of conformity, which guarantees that the products manufactured at this site meet high quality and safety standards.

The production of medicines in Russia is possible only at factories that have a valid GMP certificate issued by the Ministry of Industry and Trade of the Russian Federation.