RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of November 18, 2020 No. 103

About procedure for certification, forming and maintaining registers of authorized persons of producers of medicines, pharmaceutical inspectors

Based on parts seven, the ninth Article 20, No. 161-Z "About drug circulation" the Ministry of Health of the Republic of Belarus DECIDES: parts four of article 21 of the Law of the Republic of Belarus of July 20, 2006

1. Approve:

The instruction about requirements imposed to authorized persons of producers of medicines, and procedure for their certification (is attached);

The instruction about procedure for forming and maintaining the register of authorized persons of producers of medicines of the Republic of Belarus (is attached);

The instruction about procedure for forming and maintaining the register of pharmaceutical inspectors of the Republic of Belarus (is attached).

2. Determine that producers of medicines provide the direction of the officials on whom responsibility for quality of the medicines made and issued in realization, is conferred on the training specified in Items 9 and 10 of the Instruction on requirements imposed to authorized persons of producers of medicines and procedure for their certification since May 1, 2021.

3. This resolution becomes effective after its official publication.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of November 18, 2020 No. 103

The instruction about requirements imposed to authorized persons of producers of medicines and procedure for their certification

1. This Instruction determines requirements imposed to education, training and length of service of authorized persons of producers of medicines and procedure for carrying out their certification.

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

certification – assessment procedure of theoretical knowledge and practical skills of the official of the producer of medicines on the right of implementation of professional obligations of the authorized person by it by the corresponding type (types) of the works and services connected with industrial production of the medicines specified in the license for implementation of pharmaceutical activities regarding industrial production of medicines and their wholesale (further if other is not established, – production of medicines);

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