According to the Law of the Republic of Belarus “On medicinal products”, import and sale of medicines in Belarus are allowed only after state registration (confirmation of state registration). Both finished medicinal products and active pharmaceutical ingredients are subject to registration.

The Registration Certificate is issued in the name of the Applicant (Marketing Authorization Holder – MAH) that can be both a resident and a non-resident of the Republic of Belarus.

Expert evaluation during registration of finished medicinal products and active pharmaceutical ingredients is performed by the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” of the Ministry of Health of the Republic of Belarus (website: http://www.rceth.by/). 

Registration of medicinal products may be performed under the “national” procedure until 31 December 2020, or under the “centralized” procedure; and only under the “centralized” procedure of the EAEU after 31 December 2020.

The procedure for national registration is described below. You can get information about registration under the EAEU’s unified rules by clicking on the link.

The national registration procedure in Belarus follows a “general” or “simplified” route. Registration under the “simplified” route is available for medicines registered in countries with high regulatory standards. 

Simplified state registration

Starting from 31 December 2019, Presidential Decree No. 499 “On Circulation of Medicines” approved medicines that are subject to state registration in a simplified procedure:

1. Medicinal products registered by authorized bodies of foreign states: Australian Union, Austrian Republic, United States of America, Canada, Swiss Confederation, Japan, United Kingdom of Great Britain and Northern Ireland, Federal Republic of Germany, Kingdom of Denmark, Kingdom of the Netherlands, Kingdom of Sweden, Kingdom of Spain, Portuguese Republic.
2. Medicines registered by the competent authority of the European Union under the central procedure for application in the territory of States: Australian Union, Canada, Republic of Austria, United States of America, Japan, Swiss Confederation, United Kingdom of Great Britain and Northern Ireland, Federal Republic of Germany, Kingdom of Denmark, Kingdom of the Netherlands, Kingdom of Spain, Portugal, Kingdom of Sweden.
3. Medicines for tuberculosis, hepatitis C, HIV, vaccines that have undergone a World Health Organization prequalification programme in accordance with the WHO/PQT and HPV Joint Procedure of 16 May 2018 to assess and accelerate government registration of pharmaceuticals and vaccines prequalified by WHO.

Procedure of specialized assessment of registration materials under “simplified” procedure should not exceed 30 working days. State fees for the “simplified” registration procedure are also decreased. 

National registration by “general” route 

The procedure for national state registration of medicinal products was approved by Law No. 161-3 “On medicinal products” and Resolution No. 156 “On approving the consolidated list of administrative procedures” with amendments dated July 28, 2018.

Belarus is a country with high standards of regulation of marketed medicinal products. Inconsistencies between approved and actual packaging layouts, instructions for use and (or) package leaflets, quality certificates may cause rejection of the medicinal product and temporary or permanent prohibition on sales.

The registration dossier is accepted both in the national and in the CTD format. Regardless of the format of the registration dossier, it is necessary to develop specific national documents, namely:

• Application for registration of the medicinal product.
• ND (Normative document) – regulatory document that includes the composition of the finished product, specification for release and shelf life, quality control methods, information on storage conditions, information on the manufacturers, etc.
• Instructions for medical use for the prescription medicinal product and (or) package leaflet for the OTC medicinal product.
• Graphical layouts of the primary and secondary packaging.

The last update of Regulation No. 52 introduced special requirements to validation documents, specifications and Normative document (ND), confirmation of copies of provided reports on drug stability, documents of the substance manufacturer and many others were put forward. The main peculiarity of requirements to a set of documents is provision of a certified copy of the contract between an applicant and a manufacturer of a medicinal product (in case of their difference).  

The dossier is submitted in paper form, the possibility of filing the dossier in electronic form is not available.

Part of the documentation must be submitted with translation into Russian or Belarusian. Part of the administrative documentation must be submitted according to the requirements for international legalization of documents.

The stages of the registration procedure may be presented as follows:

1. Preparation of the documents and payment for the initial expert evaluation.
2. Submission of the documents and implementation of the initial expert evaluation.
3. Obtaining the conclusion on the initial expert evaluation, obtaining the invoice and payment for the specialized expert evaluation.
4. Implementation of the specialized expert evaluation of the registration materials for the medicinal product, providing responses to expert observations if necessary.
5. Implementation of laboratory control of samples according to a draft of the regulatory document for compliance with the requirements stated in the specifications; providing responses to expert observations if necessary.
6. Inspection of the manufacturing site if necessary.
7. Clinical trials in some cases if necessary.
8. Obtaining the conclusion on the specialized expert evaluation and adoption of the decision on recommending the medicinal product for registration at a meeting of the Academic Council of the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care”.
9. Completion and issue of the original Registration Certificate.

The period of expert activities for state registration of the medicinal product is 6 months.  A crucial point is that absolutely all activities must be completed within 6 months, including the expert evaluation of the documentation and the responses to observations, laboratory analysis of samples, inspection of the manufacturing site.

Inspection of manufacturing site 

The procedure for inspection of manufacturing site is approved by Resolution No. 72 “On approval of instruction on cases and procedure for inspection of industrial production of medicinal products” dated May 14, 2015.

Inspection is required during the first state registration of the site.

Inspection is carried out by a group of state experts. The Applicant of registration pays for the cost of the inspection activities, as well as transport and accommodation expenses.

The results of the inspection are valid for 5 years.

Language and labeling

The package labeling, instructions for use and (or) package leaflet are submitted and approved in Russian or Belarusian. According to Resolution of the Ministry of Health of the Republic of Belarus dated May 5, 2009 No. 52 “On the requirements to the documents submitted for state registration…” (with amendments dd 05.11.2019), MAH has the choice of the language. 

Registration certificate includes approved text of the instruction for use (or package leaflet) and color package artworks (mock-ups). 

The Registration Certificate is issued for a period of 5 years after the first registration, and indefinitely after renewal of registration. The medicinal product that has been placed on the market during the validity of the Registration Certificate validity is allowed to sale until the expiration date. 

The Registration Certificate consists of:

• The Registration Certificate itself with the Annex that indicates the declared price of the medicinal product;
• Permissions for use of the Normative document (ND). Whereas the Normative document itself (that includes the composition of the product, the specification for release and expiration date, quality control methods, etc.) is not amended to the package of the approved registration documents.
• Instructions for medical use and/or package leaflet.
• Color primary and secondary package artworks (mock-ups). 

Variations

According to the national legislation, the Application for variations should be submitted within three months from the date of approval by the competent authority of the manufacturing country (if this variation requires approval or notification procedure). 

Variations to the registration dossier should be applied in the following cases:

• Changes in the name of the medicinal product;
• Reorganization or changes in the name of the manufacturer;
• Changes in the manufacturer (country of the manufacturer) of the medicinal product;
• Addition of a new indication for medical use and (or) new method of administration (application) to the instructions for medical use of the medicinal product and (or) package leaflet;
• Removal of an indication for medical use and (or) method of administration (application) previously approved from the instructions for medical use and (or) package leaflet;
• Amendments to sections of the instructions for medical use of the medicinal product and (or) package leaflet, including the pharmacological and clinical sections;
• Changes in the medicinal product composition as addition, removal or substitution of a pharmaceutical substance, excipient, colorant, flavor, stabilizer, preservative, tablet or capsule coating components;
• Changes in the tests (quality parameters) indicated in the pharmacopoeial article or manufacturer’s regulatory document containing parameters and methods of quality control of the medicinal product;
• Changes in the shelf life of the medicinal product;
• Changes in its storage conditions;
• Changes in the quality control methods of the medicinal product;
• Changes in the material or type of its primary packaging;
• Changes in the medicinal product manufacturing process;
• Changes in the medicinal product package labeling;
• Changes in the number of doses in the package when filling it.

Renewal of registration

Application for renewal should be submitted not later than 3 months before expiry of the registration certificate. The renewal procedure is similar to the new registration.

In-renewal quality control of the samples can be required in case of changes in the Specification and/or control methods of the finished product. Inspection of the manufacturing site can be required. 

The period of expert evaluation should not exceed 6 months. 

The Registration certificate without expiry will be issued based on the positive decision of the expert evaluation of renewal procedure. 

Cratia provides professional services of state registration (renewals, variations) of medicinal products in Belarus. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.