RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of May 19, 2020 No. 298

About state registration of medical products, medicines and pharmaceutical substances

For the purpose of optimization and enhancement of procedure for state registration (re-registration) of medical products, state registration (confirmation of state registration) of medicines and pharmaceutical substances the Council of Ministers of the Republic of Belarus DECIDES:

1. Make changes to the following resolutions of Council of Ministers of the Republic of Belarus:

1.1. in the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269 "About approval of the Regulations on state registration (re-registration) of products of medical appointment and medical equipment":

in Item 1:

exclude the word "enclosed";

add Item with the word "(is applied)";

in the Regulations on state registration (re-registration) of products of medical appointment and medical equipment approved by this resolution:

in Item 2:

in paragraph four the word "document" shall be replaced with words "the state information resource";

word in paragraph eight "person (persons)" shall be replaced with words "the legal entity or the individual entrepreneur";

the ninth to state the paragraph in the following edition:

"the production site - the location of the production and auxiliary rooms of the legal entity or individual entrepreneur intended for accomplishment of production process of products of medical appointment, medical equipment and (or) its certain stages;";

from part three of Item 3 of the word", including acquisition, storage, registration and use of forms of registration certificates. The form of the registration certificate is the form with certain degree of protection" to exclude;

Item 3-1 part one after words to Republic of Belarus to add with words of "feasibility of reference of products to products of medical appointment and medical equipment";

in item 4:

the fourth to exclude the paragraph;

to state the paragraph of the sixth in the following edition:

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