of April 17, 2019 No. 34
About approval of the Instruction about procedure for forming of the Republican form of medicines
Based on part two of article 38-1 of the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care", subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve the Instruction about procedure for forming of the Republican form of medicines it (is applied).
2. This resolution becomes effective after its official publication.
Minister
V. A. Malashko
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2019 No. 34
1. This Instruction determines procedure for forming of the Republican form of medicines (further, unless otherwise specified, - the Form), its structure.
2. In this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus "About health care" are used.
3. Creation of the Form is directed to realization of state policy in the field of drug circulation.
4. Forming of the Form is performed by results of consideration of offers on inclusion (exception) of medicines in the Form (further, unless otherwise specified, - offers in the Form) and expert opinions about feasibility of inclusion (exception) of medicines in the Form (further, unless otherwise specified, - the conclusion) the commission created by the Ministry of Health (further - the Republican form commission).
5. The form is reviewed annually and established by the Ministry of Health after its approval by the Republican form commission, as a rule, no later than December 1 of the current year.
6. The structure of the Form is based on acting анатомо - the therapeutic and chemical classification system of medicines recommended by the World Health Organization.
7. The form is constituted according to international non-proprietary names of medicines, and in case of their absence - according to chemical names according to the systematic or replaceable nomenclature with indication of dosage form and dosage.
8. In the Form the medicine price for unit of measure (for release form dosage) is specified on which this medicine was purchased as a result of carrying out public procurement in the year preceding approval of the next edition of the Form.
9. The form is constituted in form according to appendix 1.
10. Offers in the Form are made in the Republican form commission:
chief regular and non-staff specialists of the Ministry of Health;
chief regular and non-staff specialists of head departments of health care of regional executive committees and Healthcare Committee of the Minsk city executive committee;
heads of the medical scientific organizations, the state organizations of health care subordinated to the Ministry of Health;
heads of the public institutions of education performing preparation, advanced training and (or) retraining of specialists with the higher or secondary vocational medical, pharmaceutical education;
the representatives of legal entities or individual entrepreneurs having special permission (license) for the implementation of medical and (or) pharmaceutical activities issued according to the procedure, established by the legislation;
representatives of domestic and foreign manufacturers of medicines, and also their representations.
11. Offers in the Form are constituted according to the requirements to submission of information on the medicine offered to inclusion (exception), specified in Chapter 4 of this Instruction, in form according to appendix 2, except as specified, specified in part two of this Item.
Offers on possibility of inclusion (exception) of medicine (medicines) for treatment of orphan (rare) diseases in the Form are constituted in form according to appendix 2-1.
12. Data on efficiency (are reflected in form Item 10 of the offer in the Form, except for offers on possibility of inclusion (exception) of medicine for treatment of orphan (rare) diseases) and safety (offers on possibility of inclusion (exception) of medicine for treatment of orphan (rare) diseases are reflected in form Item 11 of the offer in the Form, except for) medicine should be represented based on results of systematic reviews, metaanalyses, randomized controlled clinical trials published in the scientific reviewed seal and short summaries of these researches with observance of the following structure: name of research, authors, venue of research; design of research; the studied nosology; medicinal means of comparison; criteria for evaluation of efficiency; results of research with indication of digital values; conclusions; sponsors of research, conflict of interest of authors. Full text report versions and (or) Articles of clinical trials shall be provided as appendices.
Results of clinical trials shall be presented in the form of references to Articles in the reviewed scientific publications which are in open entry, and in case of their absence – in the form of copies of reports on the conducted researches or Articles from periodic scientific publications which are not in open entry.
It is necessary to determine degree of substantiality of efficiency of medicine by each of the provided researches. Certain levels of substantiality of efficiency of medicine can be reviewed afterwards. At the end of each research it is necessary to specify information on his sponsors and conflict of interest of authors.
In addition data on safety of medicine can be provided based on data national and foreign systems of pharmakonadzor.
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