RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS
No. 78 dated September 24, 2020
On the criteria for trade names of medicinal products
On grounds of paragraph thirteen of part twenty-two of Article 10 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "On Medicine Circulation", the Ministry of Health of the Republic of Belarus RESOLVES:
1. To approve the Regulation on the criteria for trade names of medicinal products (attached).
2. This Resolution shall enter into force on November 20, 2020.
 
Acting Minister	D.L. Pinevich	
 
 	APPROVED
Resolution of 
the Ministry of Health
 of the Republic of Belarus
 No. 78 dated November 24, 2020	
REGULATION
 on the criteria for trade names of medicinal products
1. This Regulation defines the criteria for trade names of medicinal products.
2. In this Regulation the terms and their definitions are used in the meanings established by the Law of the Republic of Belarus "On Medicine Circulation", as well as terms in the meanings determined by international legal acts constituting the law of the Eurasian Economic Union in the field of medicine circulation.
3. The trade name of the medicinal product shall be chosen independently by the manufacturer of the medicinal product or the holder of the registration certificate for the medicinal product. At the same time, the holder of the registration certificate ensures compliance with the legislation on intellectual property.
4. The trade name of a medicinal product may be:
a new invented word (word combination);
international common, non-proprietary (generic) name, scientific (chemical) name, accompanied by a trademark or the name of the holder of the registration certificate.
5. If the trade name of a medicinal product is a new invented word (word combination), it should not be confusingly similar (graphically or phonetically) or reproduce another international non-proprietary or common (generic) name, scientific (chemical) name or trade name of another medicinal product.
6. The following general criteria apply to trade names of medicinal products:
6.1. it is not allowed to use the following as a trade name of a medicinal product:
a name that fully reproduces the name of a dietary food supplement;
a name consonant with obscene words;
a word (words) representing the medicinal product as unique, the most effective, exclusive in the absence of side effects, etc.;
designations identical or having a phonetic similarity with the official names of objects of historical and cultural heritage of the Republic of Belarus, objects of world cultural heritage or natural heritage;
6.2. the trade name of a medicinal product shall not have additional meanings misleading about the therapeutic properties of this medicinal product;
6.3. the trade name of the medicinal product shall not be misleading with respect to its composition;
6.4. it is allowed to use partial abbreviations and alphabetic acronyms in the trade name of the medicinal product;
6.5. it is not allowed to use the trade name for the medicinal product, if it is of an advertising nature in relation to the therapeutic and (or) pharmaceutical characteristics and (or) composition of the medicinal product;
6.6. the use of the name of the holder of the registration certificate for the medicinal product as part of its name must correspond to all or part of the official name of the holder of the registration certificate specified in its constituent documents;
6.7. international non-proprietary names can be used as a trade name of a medicinal product in relation to medicinal products containing only one active pharmaceutical ingredient.
7. The trade name of a combined medicinal product shall be sufficiently different from the names of individual active ingredients and (or) other combined medicinal products containing the same active ingredient (s).
8. The trade names for medicinal products containing the same active substance, but used for different indications, shall be different.
9. When adding a new serotype to a vaccine consisting of multiple serotypes, the original trade name may be retained. In this case, the number of serotypes contained should be indicated after the name. The description of the serotypes contained is given in qualitative and quantitative composition, in the approximate format of the proposed trade name and may be as follows: "Trade name + X (number of serotypes)".
10. When adding different types of antigens, it is allowed to retain the original trade name. In this case, the type of antigen should be indicated after the name. The description of the antigens contained is given in qualitative and quantitative composition, in the approximate format of the proposed trade name and may be as follows: "Trade name + type of antigen".
11. The trade names of radiopharmaceutical medicinal products shall not include the names of target organs.
The trade names of radiopharmaceutical medicinal products shall not include the numbers. If numbers are present in the designation of a radionuclide, they shall be indicated in the superscript in the following form: "mass number Element + trade name".
12. For the trade name of a medicinal product, one of the indications of which is diagnostics, etiopathogenetic or pathogenetic treatment (treatment aimed at the mechanism of development of the disease) of orphan (rare) diseases, it is necessary to provide a separate (other) trade name that will be assigned to the medicinal product intended exclusively for the treatment of orphan (rare) diseases.