Pharmaceutical activities in the Republic of Belarus
Pharmaceutical activities relate to spheres that are regulated sufficiently detailed by legislation of the Republic of Belarus. There are the following components of the pharmaceutical activities:
- industrial production of medicines;
- wholesale trade in medicines;
- pharmacy manufacture of medicines;
- retail trade in medicines.
In addition to these components the issues of storage, transportation, medical use, disposal, advertising of medicines, pricing of medicines are also regulated.
1. Licensing of pharmaceutical activities
Licensing authority is the Ministry of Health.
Licenses are issued for a period of 10 years with the possibility of extension. In case the name, location of the licensee's place of activity and (or) the types of works (services), as well as other information specified in the license are changed, it’s necessary to make changes in the license.
Licensing requirements and conditions apply to the following criteria:
- education, skills and experience of the manager and personnel;
- availability of premises, equipment and vehicles that are needed for activities and that meet their business requirements, which is supported by technical documentation and by the opinion of a state body;
- nomenclature of medicines claimed for production that is coordinated with state authorities.
2. Registration of medicines
Legislation of the Republic of Belarus prohibits the import, sale and medical use of medicines that are not registered in Belarus. The registration procedure includes several stages:
1. preparation and submission of the registration dossier, which includes the established documents. There are certain requirements to the content and execution of documents established by the Ministry of Health;
2. conclusion of a contract for the provision of services for organizing and conducting of works for the state registration (re-registration) of medicinal products;
3. examination of the registration dossier, and the term for its carrying out shall not exceed 30 days from the date of the contract;
5. conduct of testing of control methods over the quality of medicines;
6. inspection of industrial production of medicines to check the compliance with the requirements of Good Manufacturing Practice approved by the Ministry of Health;
7. adoption by the Ministry of Health of the decision on state registration (denial of state registration) of medicinal products;
8. in case the Ministry of Health makes a decision on the state registration of medicinal products — entry of information about them into the State register, execution and issuance of the registration certificate.
In specific cases some of the prescribed procedures may not be required.
3. Pricing in medicines
Legislation of the Republic of Belarus establishes the limits of wholesale and trade (used in the retail trade) markups that must be met by distributors and retailers. The amount of the markup depends on the base cost (price of the Belarusian manufacturer or price of the imported goods with due account of customs duties, taxes and transportation costs), and this increases the base cost. Wholesale markups are installed within 2 - 11%, trade markups - 2 - 30%.
4. Advertising of medicines
In addition to the general requirements for advertising of any goods there are certain restrictions and prohibitions on advertising of medicines.
So, as a general rule, advertising of medicines is allowed only if the advertiser has agreement from the Ministry of Health of the Republic of Belarus.
Placement (distribution) of advertising of medicines, which are dispensed only on prescription, is allowed only in specialized print media, as well as in places of medical or pharmaceutical exhibitions, seminars, conferences and other similar events.
Advertising of medicines that are not registered in the Republic of Belarus is prohibited.
There are also certain requirements for the content of advertising materials.
It should be noted that legislation also regulates in detail other issues related to the handling of medicines: storage, transportation, disposal and etc. It’s noteworthy that there are certain measures on protection of the Belarusian (Russian) medicine manufacturers. This is done by establishing a list of Belarusian-made (Russian-made) medicines mandatory for availability in pharmacies of all forms of ownership.