of March 20, 2008 No. 52
About approval of the Instruction about procedure for submission of information on the revealed collateral reactions to medicines and control of collateral reactions to medicines
Based on article 11 of the Law of the Republic of Belarus of July 20, 2006 "About medicines" the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve the enclosed Instruction about procedure for submission of information on the revealed collateral reactions to medicines and control of collateral reactions to medicines.
2. This resolution becomes effective after its official publication.
First Deputy Minister
R.A.Chasnoyt
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of March 20, 2008 No. 52
1. This Instruction determines procedure for submission of information on the revealed collateral reactions to medicines (further - collateral reaction) and control of collateral reactions to medicines.
2. In this Instruction the main terms in the values established by the Law of the Republic of Belarus of July 20, 2006 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258), and also the following terms and determinations:
probable cause and effect relationship between collateral reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of collateral reaction are connected on time with medicine acceptance cannot be explained with availability of associated diseases or at the same time accepted other medicines, regress after the medicine acceptance termination;
possible cause and effect relationship between collateral reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of collateral reaction are connected on time with medicine acceptance can be explained with availability of associated diseases or at the same time accepted medicines, information on results of the termination of acceptance of medicine is absent or is doubtful;
reliable cause and effect relationship between collateral reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of collateral reaction are connected on time with medicine acceptance cannot be explained with availability of associated diseases or at the same time accepted other medicines, regress after the termination of acceptance of medicine and arise in case of repeated acceptance of this medicine;
adverse ratio risk advantage for medicine (further - adverse ratio) - the characteristic of medicine testimonial of excess of risk of development of collateral reactions over the expected therapeutic efficiency of medicine in case of its medical application in the dose specified in the instruction on medical application and (or) leaf insert;
unexpected collateral reaction - collateral reaction, nature or weight of which will not be approved with the available information on medicine specified in the instruction on medical application and (or) leaf insert or the program (protocol) of clinical testing;
cause and effect relationship assessment between collateral reaction and acceptance of medicine - determination of probability that the accepted medicine was the reason of development established collateral reaction;
the suspected medicine - medicine between which acceptance and development of collateral reaction cause and effect relationship availability is suspected;
the suspected collateral reaction - collateral reaction in case of which cause and effect relationship between acceptance of medicine and development of collateral reaction is possible;
profile of safety of medicine - set of all collateral reactions which can develop in case of medical application of medicine in the dose specified in the instruction on medical application and (or) leaf insert;
serious collateral reactions - collateral reactions which regardless of the accepted dose of medicine lead to death or pose threat for life, or require delivery of health care in stationary conditions, or lead to the permanent or expressed restrictions of viability (disability), to congenital anomaly (malformation), or require medical intervention for prevention of development of the listed conditions;
doubtful cause and effect relationship between collateral reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of collateral reaction are not connected obviously on time with acceptance of medicine and can be explained with availability of associated diseases or at the same time accepted other medicines;
ratio risk advantage - ratio of the estimated risk of development of collateral reactions in case of medical application of medicine to the expected therapeutic efficiency;
essential changes of assessment of safety of medicine - the changes based on results of control of collateral reactions after state registration of medicine which lead to cancellation or suspension of action of the registration certificate of medicine or modification and (or) amendments in earlier approved instruction on medical application and (or) leaf insert;
conditional cause and effect relationship between collateral reaction and acceptance of medicine - the cause and effect relationship characterizing collateral reaction which assessment requires receipt of the additional information about collateral reaction and (or) about the patient accepting this medicine, or information analysis about the revealed collateral reaction it is not ended at the time of cause and effect relationship assessment between collateral reaction and acceptance of medicine.
3. Health and pharmaceutical workers provide information on the revealed collateral reactions to medicines in the republican unitary enterprise "The Center of Examinations and Testing in Health Care".
The republican unitary enterprise "The Center of Examinations and Testing in Health Care" performs acceptance, accounting and assessment of all information on the revealed collateral reactions to medicines arriving from health and pharmaceutical workers, and also bodies and the organizations (including international) other countries exercising control of safety of medicines.
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The document ceased to be valid since May 21, 2015 according to Item 2 of the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 48.