Supervisory and Authorization System of the Ministry of Health of Belarus

Pharmaceuticals and medical products form a specific category of products which may damage human health in case production and use rules are violated, thereby necessitating a tight control system starting from their production to consumption. To ensure state guarantees of providing the population with high-quality drugs, the public enterprise Republican Center of Examination and Testing in Health Sector was established.

The drug supervisory and authorization system encompasses the following spheres:

- developing normative documents regulating circulation of drugs and indicators of their efficiency, safety and quality;

- supervising the observance of rules of conducting drug trials on animals and humans;

- accrediting therapeutic and preventive institutions to conduct clinical trials of drugs and certify specialists involved in these trials;

- controlling the process of pioneering and production of drugs at pharmaceutical enterprises;

- recording and generalizing side effects of drugs and preparing recommendations to limit their application or withdraw them from the sales outlets, if required;

- controlling drug advertising in the mass media;

- issuing special permits (licenses) entitling to pharmaceutical activities and exerting control over the observance of rules of pharmaceutical activity by economy entities having such licenses irrespective of category of ownership and departmental subordination;

- issuing licenses for importing drugs from other countries, including special licenses for import, export and transit of narcotics, psychotropic substances and precursors;

- exerting the state control over quality of drugs both produced locally and imported, certifying them.

The supervisory and authorization system of medical equipment is designated for examining the documentation as regards compliance with requirements of safety, quality and efficiency of medical products and medical equipment, arranging and conducting all necessary tests, providing organizational and technical support to the Medical Equipment Committee and preparing proposals regarding their production and medical application.

The supervisory and authorization system of licensing is designated to examine the documentation, professional knowledge, conduct field inspections to determine the degree of readiness for receiving licenses for medical, pharmaceutical and other categories of activity being under the authority of the Ministry of Health, to control the observance of conditions of the activity being licensed.

IV. Read the text and decide which of the following statements are correct.

1. Republican Center of Examination and Testing in Health Sector was established to provide a tight control system starting from pharmaceuticals production to consumption.

2. The drug supervisory and authorization system controls normative documents regulating circulation of drugs and indicators of their efficiency, safety and quality.

3. The drug supervisory and authorization system promotes drug advertising in the mass media.

4. The drug supervisory and authorization system withdraw drugs from the sales outlets, if required.

5.The drug supervisory and authorization system finances the process of pioneering and production of drugs at pharmaceutical enterprises.

V. Speak about the functions of the supervisory and authorization system.