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Drug Registration Process in Belarus

Drug Registration Process in Belarus

MoH: Ministry of Health of the Republic of Belarus.

MoH website:  https://minzdrav.gov.by/en/

Local Authorised Representative: yes

Liscense Validity: 5 years.

Liscense renewal:  3 months before expiry.

Registration timeline: 210 days.

Regulation: Issues associated with the state registration of medicinal products in Belarus are regulated by the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78.

Dossier: Common Technical Document (CTD) format.

With 9.5 million citizens, the Republic of Belarus is one of the biggest post-Soviet nations and a member of the Eurasian Economic Union (EAEU), which also includes Kyrgyzstan, Kazakhstan, Russia, and Armenia. The state’s regulatory policies are greatly impacted by Belarus’s membership in the EAEU: the “national” and “centralized” medical product registration processes are available.

Registration Process of Medicine in Belarus

The Republic of Belarus’s “On Medicinal Products” Law states that sales and imports of medications are only permitted upon state registration (or confirmation of state registration). Registration is required for both completed pharmaceutical products and active pharmaceutical components. The applicant, also known as the Marketing Authorization Holder (MAH), who may or may not be a resident of the Republic of Belarus, is named on the Registration Certificate. The Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” of the Ministry of Health of the Republic of Belarus conducts expert review during the registration of finished pharmaceutical products and active pharmaceutical components.

The following are the registration procedure’s stages:

  1. Preparing the paperwork and paying for the first professional assessment.
  2. Submitting the paperwork and carrying out the preliminary expert assessment.
  3. Acquiring the results of the preliminary expert assessment, acquiring the bill and payment for the additional expert assessment.
  4. Application of the specialized expert review of the medicine’s registration papers, and if required, supplying comments to expert observations.
  5. Implementing laboratory control of samples in accordance with a draft of the regulation document to ensure compliance with the specifications’ requirements; responding, as needed, to expert observations.
  6. Examination of the production facility, if required.
  7. Clinical studies in some cases, if required.
  8. Obtaining the results of the specialized expert review and the approval of the recommendation to register the medication at a meeting of the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care’s Academic Council.
  9. Issuance and completion of the first Registration Certificate.

Registration Requirements for Registration of Medicines in Belarus

To register a medication in accordance with the requirements of the Eurasian Economic Union, the “Centre of Examinations and Tests in Health Service” must receive the following documents:

1) Application form and papers attached:

  • A legalized Power of Attorney granted by the representation to the applicant;
  • Legalized copies of the Manufacturer’s Authorizations, granted by the relevant authorities of the producers’ home countries, for each production site engaged in the manufacturing process;
  • Official copies of the GMP Certificates, granted by the relevant authorities of the producers’ home countries, for each production site participating in the manufacturing process;
  • certified copies of the Eurasian GMP Certificates for all manufacturing sites involved in the manufacturing process issued by one of the competent Authorities of the member state of the Eurasian Economic Union: Russia, Belarus, Kazakhstan, Kyrgyzstan, or Armenia (if available) or the Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in the manufacturing process issued by one of the competent Authorities of the member state of the Eurasian Economic Union: Russia, Belarus, Kazakhstan, Kyrgyzstan, or Armenia.
  • Legalized copy of the registration certificate, or a statement explaining its absence, from the applicant’s and/or manufacturer’s national authorized organization;
  • An official list of the nations in which a medicine has been registered, re-registered, or canceled, together with the dates, numbers, and validity of the registration certificates, as well as the grounds for the cancellation;
  • Suggested prototypes for Belarus’s market;
  • official copy of the free sale certificate (if available), the certificate of pharmaceutical product, etc.

2) A registration dossier in Common Technical Document (CTD) format.

3) Standard samples and samples of pharmaceutical substances.

Note: The registration dossier is accepted both in the national and in the CTD format.  

Simplified State Registration of medicinal products

By means of the centralized procedure of recognizing the state registration in another member state of the Eurasian Economic Union after issuing the Eurasian Certificate, the state registration procedure for medicinal products conducted in accordance with the demands of the Eurasian Economic Union permits conducting the simplified state registration of said medicinal product in other member states of the Eurasian Economic Union.

Without having to wait for registration in the first nation, it is also feasible to apply for simplified state registration of the medication in another Eurasian Economic Union member state. However, in this scenario, the application for state registration in another member must be filed with the appropriate authority of that Eurasian.