RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 17, 2015 No. 44

About procedure and conditions of informing health and pharmaceutical workers on medicines

Based on part three of article 28 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", the paragraph of the twelfth subitem 8.17 of Item 8 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 and conditions of informing health and pharmaceutical workers on the medicines included in the State register of medicines of the Republic of Belarus, by manufacturer representatives of medicines it (is applied).

2. This resolution becomes effective since May 21, 2015.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 44

The instruction about procedure and conditions of informing health and pharmaceutical workers on the medicines included in the State register of medicines of the Republic of Belarus, manufacturer representatives of medicines

1. This Instruction determines procedure and conditions of informing health and pharmaceutical workers (further - workers) the organizations of health care, including the medical scientific organizations, other organizations which along with the main activities perform medical, pharmaceutical activities (further - the organizations), about the medicines included in the State register of medicines of the Republic of Belarus (further - informing workers), manufacturer representatives of medicines.

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

3. The manufacturer representatives of medicines having the higher medical, pharmaceutical education and having knowledge in the sphere of drug circulation can perform informing workers (further – representatives).

4. Representatives perform informing employees of the organizations according to the procedure, established by this Instruction, in the following forms:

oral performance with (without) demonstration of information and other materials about medicine, including on electronic media (further – information materials), when holding the meetings, conferences, seminars, symposiums and other actions (further – actions) determined by the Ministry of Health;

placements (distribution) of information materials within the held events;

provisions of information materials in the organization in electronic form or on paper (without visit of the organization).

5. Information materials are led up to employees of the organization by the authorized person determined by the order of the head of the organization (further – the authorized person).

The authorized person performs maintaining the magazine of registration of informing health and pharmaceutical workers on the medicines included in the State register of medicines of the Republic of Belarus in form according to appendix.

6. Representatives for the purpose of informing employees of the organization have no right:

perform informing workers in other forms, not stipulated in Item the 4th this Instruction;

provide unreliable and (or) incomplete information about the medicines including having the identical international non-proprietary name;

extend (to provide) on paid or non-paid basis according to article 25 of the Law of the Republic of Belarus "About drug circulation" samples of medicines, including for the purpose of their medical application patients, and also the information materials representing the forms of recipes of the doctor printed by typographical method on which the trade name of medicine, and also forms containing information of advertizing nature on medicines is in advance printed;

carry out any actions directed to establishment of interest of workers in appointment or realization to patients of medicines;

violate other requirements established by the legislation.

7. Data of representatives to informing employees of the organization:

7.1. shall correspond to the data of the instruction on medical application (leaf insert) and (or) general characteristic of medicine approved by the Ministry of Health in case of state registration (confirmation of state registration) of medicine and to contain the following information:

trade name of medicine (in the presence);

composition of medicine and the name (names) of active ingredient (substances) with use of international non-proprietary names;

indications to medical application of medicine according to the instruction on medical application (leaf insert) and (or) general characteristic of medicine;

precautionary measures and special instructions in case of use of medicine, contraindication to application and collateral reactions;

interaction with other medicines;

leave conditions from drugstores;

the name of the producer of medicine and its official distributor (dealer) in the Republic of Belarus;

specifying of date of coordination by the Ministry of Health of the instruction on medical application (leaf insert) and (or) general characteristic of medicine.

The comparative characteristic of medicine represented in data shall be used in relation to the proof of equivalence of generic medicine to original medicine. Use of the discrediting comparative information in respect of other medicines is not allowed.

Approval "new" concerning medicine can be used if after state registration of this medicine in the Republic of Belarus there passed no more than 3 years.

Use of the quotes, tables and other illustrative materials taken from the reviewed scientific publications or other scientific publications shall be reproduced and followed by references to the source precisely. Results of the preclinical (not clinical) researches or other researches of medicine conducted out of human body shall have accurate instructions that the effects (actions) of medicine gained during these researches were not studied and were not reproduced on patients;

7.2. shall conform to other requirements established by the legislation.

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