Pharmaceutical products (pharmaceuticals) can be manufactured only by a legal entity that holds a pharmaceutical licence covering manufacturing (manufacturing licence) issued by the Ministry of Healthcare of the Republic of Belarus (Ministry). This licence allows industrial manufacturing of and wholesale trade in pharmaceuticals, which must be performed in compliance with Good Manufacturing Practice and Good Wholesale Practice approved by the Ministry.
Requirements for obtaining a licence
A legal entity seeking a manufacturing licence must:
- specify the nomenclature of the pharmaceuticals preliminarily adjusted by the Department of the Pharmaceutical Industry of the Ministry;
- have at its disposal sufficient and appropriate premises as well as technical equipment complying with the requirements established by law;
- enter into an employment contract with a qualified person responsible for the quality of the manufactured pharmaceuticals.
Additional requirements may be established depending on the type of product being manufactured.
Issue of licence
The Ministry decides to issue the manufacturing license (or justifies refusal to issue) within 15 days from receiving the application; the term may be prolonged for 10 days if additional examination is required. The licence is valid for 10 years and can be renewed.
ENTERING THE MARKET
Pharmaceuticals manufactured and/or sold within Belarus, including pharmaceutical substances used in the manufacturing process, must be registered by the Ministry in the State Register of Pharmaceutical Products unless intended for the purposes of clinical trials or made in a pharmacy. Marketing authorisation for pharmaceuticals is granted by the Ministry.
Requirements for marketing authorisation
A person seeking marketing authorisation must:
- conclude an agreement on provision of services with the Centre for Expertise and Testing in Healthcare (CETH); and
- submit to the CETH the documents and information required by law (eg reports on pre-clinica and clinical trials, information on experience of application of the pharmaceutical).
Issuing marketing authorisation
On the basis of the application and upon examination of a pharmaceutical, CETH prepares a draft decision to issue (or to refuse to issue) marketing authorisation which is then adopted by the Ministry. Refusal must be justified. The whole procedure should take no more than 6 months from the day of receiving the application. Marketing authorisation is granted for 5 years, then re-registration is required.
Retail or wholesale trading (without manufacturing) requires a pharmaceutical licence covering trade services (trade license). This licence may cover one or several of the following activities: preparation of pharmaceuticals in pharmacies, the pharmaceuticals retail trade, and the pharmaceuticals wholesale trade. Within Belarus retail trade can be performed exclusively through pharmacies. Requirements for obtaining this licence are similar to those for a manufacturing licence; particular requirements vary depending on the type of the activity planned.
All clinical trials of pharmaceuticals must comply with Good Clinical Practice adopted by the Ministry. Clinical trials can be commenced only if pre-trial research has shown that the pharmaceutical is safe and effective and if the risk of side effects is reasonable in the light of the expected positive effects. The rights of individuals participating in the trial must be protected according to law. Clinical trials of pharmaceuticals are performed by state healthcare organisations defined by the Ministry.
Requirements for clinical trial authorisations
Authorisation of clinical trials requires the following information to be submitted to the CETH:
- trial protocol indicating the objective, design, methodology, statistical criteria, and organisation of the trial;
- other documents and information required by law (eg investigator brochure, information on investigator's qualification, informed consent form).
Clinical trial agreement
Performance of clinical trials as a subject matter can only be set in contracts between a sponsor (or a contract research organisation) and a healthcare organisation, not with an investigator. A clinical trials agreement requires approval by the Ministry. A template form of a clinical trials agreement is set by legislation. The flexibility of institutions in accepting amendments to the template form differs.
Issue of permit
Preliminary investigation of the application is performed by the CETH within 10 days. Then the CETH conducts a specialised examination of the material of the clinical trials within 30 days. This term can be extended if the CETH requests additional information.
PROMOTION OF PHARMACEUTICAL PRODUCTS
Advertising and presents
Advertising pharmaceuticals requires approval of the Ministry. Advertising pharmaceuticals that require medical prescription to the general public is prohibited. Advertising may not contain images or statements of medical professionals and non-commercial healthcare organisations. Advertising to doctors and pharmacists is subject to different specific rules. No material or other kind of benefit for prescribing pharmaceutical products may be accepted by doctors of Public Health Institutions (PHI), since acceptance may be qualified as "illegal remuneration" from the criminal law perspective. Giving presents to PHI doctors may also be considered as financial motivation for recommending certain pharmaceuticals, which is prohibited under a Letter from the Ministry which binds PHI. Moreover, some PHI doctors (eg heads of PHI) may be considered state officials from the perspective of anti -corruption laws so that gifts may be qualified as bribery; giving them souvenirs at protocol and other formal events with a value not exceeding EUR 44 is allowed.
Professional medical training and marketing events
Sponsoring medical training or marketing events is qualified as gratuitous aid which is subject to specific regulation. Sponsoring by a foreign entity is considered as foreign gratuitous aid which must be registered by the recipient of the aid according to the procedure established by law and must fit the purpose "research, development, training or implementation of research programs". If a sponsor is a local entity, an agreement on gratuitous aid must be concluded with the recipient; the aid must fit the purpose "support of activity in the sphere of protection of the population's health, promotion of a healthy lifestyle".
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SORAINEN Pharmaceuticals & Life Sciences Practice lawyers offer an understanding of the pharmaceuticals business, alongside comprehensive sector knowledge and experience. Understanding the Baltic and Belarusian pharmaceuticals market puts the firm in a unique position to assess risks and stay ahead of the innovation curve.
SORAINEN offers expertise in all key pharmaceuticals areas in the Baltic States and Belarus, including:
- pharmaceuticals industry research;
- trade, marketing and distribution;
- licences, permits, certification, clinical trials and other regulatory issues;
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- representation before local authorities and courts.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.