RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of September 18, 2020 No. 545

About issue of the certificate of pharmaceutical product

Based on part of the twentieth article 10 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Council of Ministers of the Republic of Belarus DECIDES: No. 161-Z

1. Approve Regulations on procedure for issue of the certificate of the pharmaceutical product provided for international trade it (is applied).

2. No. 175 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022

3. To the Ministry of Health to take measures for implementation of this resolution.

4. This resolution becomes effective since November 20, 2020.

Approved by the Resolution of Council of Ministers of the Republic of Belarus of September 18, 2020 No. 545

Regulations on procedure for issue of the certificate of the pharmaceutical product provided for international trade

1. This Provision determines procedure for issue of the certificate of the pharmaceutical product provided for international trade according to recommendations of the World Health Organization on the medicines intended for industrial production for export (further - the certificate).

2. For the purposes of this provision terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation" are used.

3. The certificate is issued to the producer or the holder of the registration certificate of medicine who is the legal entity, the individual entrepreneur registered in the Republic of Belarus (further - the applicant), on the medicine intended for industrial production for export for the purpose of its registration in the states which legislation provides submission of the certificate.

4. Issue of the certificate is preceded by conducting examination of compliance to information of the applicant provided in the statement in the form established by the Ministry of Health, to the data containing:

in the registration file and the registration certificate on the medicine included in the State register of medicines of the Republic of Belarus (further - the State register) (in case of their availability);

in the registration file for registration of medicine in the importing country including data on the name (about the international non-proprietary name - in the presence) medicine, dosage form, structure on medicinal dose or unit of mass or amount (for not dosed medicines), primary package - for the medicine intended for industrial production only for export and not included in the State register;

in the documents confirming compliance of conditions of production of medicine to requirements of the Proper production practice (GMP).

5. The examination specified in item 4 of this provision is exercised by public institution "The state pharmaceutical supervision in the sphere of drug circulation the Gosfarmnadzor (further – Organization) based on the contract between Organization and the applicant in time which is not exceeding 15 working days from the date of its payment by the applicant.

6. For conducting the examination specified in item 4 of this provision, the applicant to Organization represents the statement called in paragraph one of item 4 of this provision and the documents provided in paragraph three of item 4 of this provision (for the medicine which is not included in the State register).

7. By results of conducting the examination specified in item 4 of this provision, the Organization draws up the conclusion about possibility (impossibility) of issue of the certificate (further, unless otherwise specified, – the conclusion) in the form established by the Ministry of Health.

In case of receipt of positive results of the examination specified in item 4 of this provision, the Organization constitutes the conclusion about possibility of issue of the certificate in triplicate and preparation of the draft of the certificate is performed. One copy of the conclusion goes to the applicant, the second copy and the prepared draft of the certificate – to the Ministry of Health. The third copy of the conclusion is stored in Organization.

In case of receipt of negative results of the examination specified in item 4 of this provision, the Organization constitutes the conclusion about impossibility of issue of the certificate in duplicate. One copy of the conclusion goes to the applicant, the second – is stored in Organization.

8. After receipt of the conclusion about possibility of issue of the certificate by the applicant the application for implementation of the ministerial procedure provided in subitem 9.12.3 of Item 9.12 of the single list of the ministerial procedures performed concerning subjects of the managing approved by the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548 is submitted in the Ministry of Health.

9. By results of the consideration of the application specified in Item 8 of this provision, and provided by Organization of the conclusion and draft of the certificate the Ministry of Health makes the decision on issue of the certificate.

10. The certificate is issued on one name of medicine for the specific importing country in the form established by the Ministry of Health.

Certificate effective period - 1 year.

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