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Belarus

The Republic of Belarus is one of the largest post-Soviet countries with a population of about 9.5 million people. The country is a member of Eurasian Economic Union (EAEU) along with Russia, Kazakhstan, Armenia and Kyrgyzstan. Membership of Belarus in EAEU significantly influences regulatory policy of the state: currently there is a choice between “national” and “unified” registration procedure for medicinal products and medical devices.

Food products for special purpose (food supplements, baby food, sports nutrition, etc.) and cosmetic products pass registration procedure according to unified EAEU Technical Regulations only.

Belarus is characterized by strong state support and protection of national manufacturer (import substitution policy) which should be definitely taken into account when deciding to market medicinal products and medical devices that have equivalents produced by national manufacturers. Nevertheless, the imported pharmaceutical products share in Belarusian market is approximately 75%.

The health care system is financed from the state budget by more than 90%, the Constitution guarantees providing patients with free medical care in public health care institutions, and there is the state system for ensuring access to medicinal products.

The central executive authority implementing the state health care policy is the Ministry of Health of the Republic of Belarus (website: http://minzdrav.gov.by/).

The Ministry of Health of the Republic of Belarus performs registration of finished medicinal products and active pharmaceutical ingredients, medical equipment and medical devices based on the expert evaluation carried out 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/).

Special purpose food products and cosmetic products are subject to state legalization (registration or declaration) under the “centralized” procedure according to the Technical Regulations of the EAEU.

 
Medicines
According to the Law of the Republic of Belarus “On Medicinal Products” import and marketing of medicinal products in Belarus are allowed only after their state registration (confirmation of state registration). Both finished medicinal products and active pharmaceutical ingredients are subjected to registration.

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

Applicant can be represented 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 Examinations and Tests in Health Service” of the Ministry of Health of the Republic of Belarus (website: http://www.rceth.by/).

 
Stages of registration procedure may be presented as follows:

  1. Preparation of registration dossier and payment of the fee for primary examination.
  2. Filing of the dossier and conducting of the primary examination.
  3. Obtaining conclusion on results of primary examination, obtaining invoice and payment of the fee for specialized examination.
  4. Conducting of specialized examination of registration materials of medicinal product, providing replies to expert observations, if necessary.
  5. Conducting of laboratory analysis of registration samples according to  draft of Normative document for compliance with the requirements stated in finished product specification; providing replies to expert observations, if necessary.
  6. Conduction of inspection at manufacturing site on compliance to GMP requirements, if necessary.
  7. Conducting of clinical trials in certain cases if necessary.
  8. Obtaining the conclusion on results of specialized examination and making decision decision on recommending medicinal product for registration at meeting of Academic Council of the Unitary Enterprise “Center for Examinations and Tests in Health Service”.
  9. Drafting and issuing of Registration Certificate.

Inspection at manufacturing site is required in case when submitted manufacturing site has not been previously registered in Belarus.

 
Duration of examination for state registration of medicinal product is 6 months.  A critical point is that absolutely all activities must be completed within 6 months including expert examination of documentation and replies to observations and deficiency letters, laboratory analysis of samples, inspection at  manufacturing site.
 
Registration Certificate is issued for 5 years after first registration, and indefinitely after renewal. Medicinal product imported and marketed during validity of Registration Certificate is allowed to be marketed until expiry date. Registration Certificate package includes the following items:

  • Registration Certificate itself with Appendix indicating declared price of medicinal product.
  • Permission for use of Normative document. At the same time the Normative document itself (that includes composition of product, specification for release and shelf life, quality control methods, etc.) is not included in the package of approved documents.
  • Instructions for medical use and/or package leaflet.
  • Artworks  of primary and secondary packages.

Package labeling, instructions for use and package leaflet are submitted and approved in Russian or Belarusian languages.

NB: Belarus is a country with strict standards of regulation of marketed medicinal products. Inconsistencies between approved artworks and actual packaging labelling, instructions for use and/or package leaflets, certificates of analysis may lead to rejection of medicinal product and suspending or prohibition of sales.

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

  • Application form for registration of medicinal product.
  • Normative document that includes composition of 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 Rx medicinal product and/or package leaflet for OTC medicinal product.
  • Artworks of primary and secondary packaging.

Dossier is submitted in paper form, filing the dossier in electronic form is not applicable.

Part of documentation should be submitted with translation into Russian or Belarusian.

Part of administrative documentation should be properly legalized.


Variations
According to national legislation Application form for variations should be submitted within three months from the date of their approval by authorized body of country of manufacturer (if this variation is applicable for approval procedure). Variations to registration dossier are provided in the following cases:

  • Changes in the name of medicinal product.
  • Reorganization or changes in the name of manufacturing site.
  • Change of manufacturing site (country of manufacturer) of medicinal product.
  • Addition of new indication for medical use and/or new method (route) of administration to instructions for medical use of medicinal product and/or package leaflet.
  • Removal of indication for medical use and/or method (route) of administration previously approved from instructions for medical use and/or package leaflet.
  • Amendments of sections of instructions for medical use of medicinal product and/or package leaflet, including pharmacological and clinical sections.
  • changes in medicinal product composition such as addition, removal or substitution of a active substance, excipient, colorant, flavor, stabilizing agent, preservative, tablet or capsule coating components.
  • changes in tests (quality parameters) indicated in pharmacopoeial article or in-house specification and methods of control..
  • Change of shelf life of medicinal product.
  • changes in storage conditions.
  • changes in quality control methods of medicinal product.
  • changes in material or type of primary packaging.
  • changes in manufacturing process of medicinal product.
  • changes in package labeling of medicinal product.
  • changes in number of doses in a package during filling process.

Renewal (confirmation of state registration) should be submitted not later than 3 months before expiry of Registration Certificate. Renewal procedure is similar to new registration procedure in Belarus.

During  renewal laboratory analysis of samples may be assigned in case if changes in specifications and/or methods of quality control of finished product have took place. During renewal it may be also required to inspect manufacturing site.

Period of examination of renewal materials is 6 months. Registration Certificate issued based on performed renewal is indefinite.

 

Pharmacovigilance
Manufacturers of medicinal products as well as healthcare and pharmaceutical professionals are obliged to submit information on identified adverse reactions according to regulations implemented by Ministry of Health of the Republic of Belarus.

Manufacturers of medicinal products are obliged to ensure implementation and functioning of pharmacovigilance system in accordance with requirements of Good Pharmacovigilance Practices approved by Ministry of Health of the Republic of Belarus. The guideline (technical code of established practice) for pharmacovigilance is developed based on EU Directive 2012/26/EU, Regulation of the European Parliament and the Council of Europe No. 1027/2012 and European Commission Regulation No. 520/2012.

Competent state authority responsible for pharmacovigilance system in Belarus is the Ministry of Health on the base of the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” (website: http://www.rceth.by/).

To assure functioning of pharmacovigilance system manufacturer of the medicinal products should appoint authorized person for pharmacovigilance in Belarus. Pharmacovigilance system of manufacturer is subjected to control by the competent authority.

 

Medical devices and medical equipment
Medical devices and medical equipment of foreign manufacture may be imported and marketed in the territory of the Republic of Belarus after state registration. Currently Application form for registration may be submitted both under “national” Belarusian and under “unified” procedure of EAEU.

When performing registration under national procedure, the Registration Certificate is valid in the territory of Belarus only. The Registration Certificate is issued for the period of 5 years. At the same time, the right to import and market is valid until 31 December 2021 (this period will be possibly rescheduled).

It is not required to appoint the authorized representative of the manufacturer-resident under national registration. The Applicant of registration may be a person who manufactures or places an order for manufacture of medical devices and medical equipment.

The registration dossier is submitted in English, with the translation of some sections of the registration dossier into Russian.

The following preliminary technical activities are carried out prior to registration:

  • Initial expert examination of the documents.
  • Inspection at manufacturing site.
  • Sanitary-hygienic tests of the devices and equipment.
  • Technical tests.
  • Specialized examination of documents.
  • Clinical trials.
  • Other studies if necessary.

After completion of preliminary technical activities the following steps are performed:

  • Filing of registration dossier by Applicant to the Ministry of Health of Belarus.
  • Reviewing of submitted documents by Ministry of Health of Belarus and taking decision on acceptance of registration.
  • Drafting and issuing Registration Certificate.

Expert activities are carried out by Unitary Enterprise “Center for Examinations and Tests in Health Service”.

Renewal of medical devices and medical equipment is performed in the following cases:

  • Expiry of Registration Certificate.
  • Changes in name of medical device or medical equipment.
  • Reorganization or change in the name of legal entity - manufacturer of medical devices or medical equipment.
  • Changes in the country of manufacturer of medical device or medical equipment.
  • Variations to technical regulatory legal documents on manufactured medical devices and medical equipment.

In case of renewal due to expiry of registration new certificate is issued with the same number and renewed period of validity. In case of renewal due to changes the amended certificate is issued with the same validity period.

The language of package labeling and instructions for use (user manual) is Russian or Belarusian.

 

Food products for special purpose

Special purpose food products are listed below:

  • food supplements;
  • sport products;
  • food products for nutrition of pregnant and breast-feeding women;
  • food products for baby nutrition;
  • food products for dietary therapeutic and dietary preventive nutrition;
  • mineral natural, therapeutic-table, therapeutic mineral water with mineralization over 1 mg/dm3 or with less mineralization, containing biologically active substances in an amount not lower than balneological norms.

Special purpose food products are subjected to state registration under “unified” procedure, according to Technical Regulations of EAEU. The authorized body for registration of special purpose food products in Belarus is the Unitary Enterprise “Center for Examinations and Tests in Health Service” (link to the website: http://rcheph.by/).

State registration of special purpose food products is indefinite and valid in the territory of all EAEU member countries: Belarus, Russia, Kazakhstan, Armenia and Kyrgyzstan.

State registration of special purpose food products of foreign manufacture is performed before the products are imported into the customs territory of the EAEU.

Prior to registration procedure it is necessary to test samples of special purpose food products in accredited testing laboratory in the territory of Belarus or another EAEU country. Therefore, state registration procedure may be presented by following stages:

  1. Testing of samples in an accredited testing laboratory.
  2. Expert examination of application form, results of the samples tests and other necessary documents confirming safety and conformity of products in accordance with the requirements of EAEU Technical Regulations.
  3. Issuing of Certificate of Conformity and entering the relevant data information into unified register of special purpose food products.

Documentation for registration should be provided in Russian or Belarusian languages.

Prior to registration it is recommended to check composition of the product as well as quality safety and labeling requirements for compliance with requirements of EAEU Technical Regulations, for example:

For all special purpose food products it is recommended to check their compliance with:

  • Technical Regulations 021/2011 "On Food Products Safety", and in particular Annex 7 “ List of Plants and Products Derived Thereof, Objects of Animal Origin, Microorganisms, Fungi and Biologically Active Substances Prohibited for Use as Components of Food Supplements”.
  • Technical Regulations 029/2012 “Safety Requirements for Food Supplements, Flavorings and Processing Aids”.
  • Technical Regulations 022/2011 “Food Products in Terms of their Labeling”.

If the special purpose food product is indicated for use by children, it is also advisable to check the compliance with:

  • Annex 8 TR TS 021/2011 “Types of Plant Raw Materials for Manufacturing of Biologically Active Food Supplements for Children from 3 to 14 Years Old and Baby Herbal Teas (Herbal Drinks) for Infants.
  • Annex 9 TR TS 021/2011 “Vitamins and Mineral Salts Used in Manufacturing of Baby Food”.
  • Annex 10 TR TS 021/2011 “Pesticides Prohibited for Use in Manufacturing of Food (Nutritional) Raw Materials Intended for Manufacturing of Baby Food”.

If special purpose food product contains oils and/or fats it is also recommended to check their compliance with TR TS 024/2011 “Technical Regulations for Oil and Fat Products”.

When registering and subsequently marketing special purpose food product special attention should be paid to the issue of package labeling. Obligatory element of labeling is an unified sign of product marketing in EAEU member states. For bulk products (in-bulk) the unified sign is indicated in accompanying documents.

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Requirements for labeling of special purpose food products are specified in Technical Regulation 022/2011 “Food Products in Terms of Their Labeling”.

Labeling is reconciled in Russian or Belarusian languages.

 

Perfume and cosmetic products

Perfume and cosmetic products (PCP) are the products intended to be applied directly to common integument of human body (skin, hair, nails, lips and external genital organs) or to teeth and oral mucosa with primary purpose of cleansing, appearance modification, odorization and/or protection, and/or physiological state maintenance, and/or care.

Perfume and cosmetic products are subjected to “unified” authorization by means of conformity assessment (in the form of declaring or state registration with following granting of Registration Certificate).

Competent bodies for authorization of perfume and cosmetics in Belarus are certification authorities accredited under Technical Regulations of Eurasian Economic Union (EAEU).

State authorization of perfume and cosmetic products is indefinite (or until variations are made in the name and/or composition of products), and is valid in the territory of all EAEU member countries: Belarus, Russia, Kazakhstan, Armenia and Kyrgyzstan.

State authorization of perfume and cosmetic products of foreign manufacturer should be performed before the products are imported into customs territory of EAEU.

Documentation for authorization should be provided in Russian or Belarusian languages.

Prior to the authorization procedure it is recommended to check the products documentation  for compliance with requirements of EAEU Technical Regulations, namely:

  1. Requirements for composition.
  2. Requirements for physical and chemical parameters.
  3. Requirements for microbiological parameters.
  4. Requirements for containing toxic elements.
  5. Requirements for toxicologic parameters.
  6. Requirements for clinical (clinical and laboratory) parameters.
  7. Requirements for manufacturing process.
  8. Requirements for consumer packaging.
  9. Requirements for labeling.

 

Declaring perfume and cosmetic products

Prior to the declaring procedure it is required to conduct testing of samples of perfume and cosmetic products in an accredited testing laboratory in the territory of Belarus or another EAEU country. Therefore, the declaring procedure may be presented by the following stages:

  1. Testing of samples in an accredited testing laboratory.
  2. Expert examination of application form, results of the samples testing and other necessary documents confirming safety and conformity of the products to requirements of the EAEU Technical Regulations.
  3. Registration of the declaration in accredited body.

Unified register of perfume and cosmetic products which havepassed declaring procedure is updated on a daily basis and is available at the following link: https://tsouz.belgiss.by/.

 

Registration of perfume and cosmetic products

List of products subjected to registration:

  • Perfume and cosmetic products for artificial tanning.
  • Perfume and cosmetic products for skin whitening/lightening.
  • Perfume and cosmetic products for personal skin protection from impact of negative workplace factors.
  • Perfumes and cosmetics for hair dyeing, lightening and highlighting.
  • Perfume and cosmetic products for perming or straightening hair.
  • Perfume and cosmetic products for depilation.
  • Perfume and cosmetic products for peeling.
  • Cosmetics for tattooing (except tattooing products applied with skin integrity damaging).
  • Intimate cosmetics.
  • Baby cosmetics.
  • Fluorinated oral hygiene products (fluorides ≥ 0.15% for solid and semi-solid products, fluorides ≥ 0.05% for liquid products).
  • Products for teeth whitening (with concentration of hydrogen peroxide 0.1-6.0%).
  • Perfume and cosmetic products produced using nanomaterials.

Prior to registration procedure it is required to conduct testing of samples of perfume and cosmetic products in an accredited testing laboratory in the territory of Belarus or another EAEU country. Therefore, the state registration procedure may be presented as the following stages:

  1. Testing of samples in an accredited testing laboratory.
  2. Expert examination of application form, results of the samples testing and other necessary documents confirming safety and conformity of the products to the requirements of EAEU Technical Regulations.
  3. Entering data on the products into unified register and issuing Registration Certificate.

The unified register of perfume and cosmetic products which have passed registration procedure is updated on a daily basis and is available at the following link:

(https://portal.eaeunion.org/sites/odata/_layouts/15/Portal.EEC.Registry.Ui/DirectoryForm.aspx?ViewId=1631d8b8-efd5-4a46-80d9-5e252e7986bb&ListId=0e3ead06-5475-466a-a340-6f69c01b5687&ItemId=231#). The national register is also maintained on the website of the State Institution “Republican Center for Hygiene, Epidemiology and Public Health” (link: http://gr.rcheph.by/default.aspx).

When authorizing and subsequently marketing perfume and cosmetic products special attention should be paid to the issue of package labeling.  Obligatory element of labeling is an unified sign of product marketing in EAEU member states which should be indicated on each product unit.

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Requirements for labeling of perfume and cosmetic products are specified in Technical Regulation 009/2011 “On Safety of Perfume and Cosmetic Products”.

Labeling should be provided in Russian or Belarusian languages.

 

The company Cratia offers provision of services for state registration of medicinal products, development and maintenance of pharmacovigilance system, registration of medical devices and medical equipment, special purpose food products and cosmetics in Belarus.

To start cooperation or get advice, you can contact us:

  • telephone +38 044 361-48-28, +38 044 221-71-29,
  • Skype: maxim.bagreev,
  • WhatsApp, Viber, Telegram +38 067 238-31-37,
  • e-mail info@cratia.ua,
  • or meet us in our office.