of April 17, 2015 No. 48
About procedure for submission of information on the revealed undesirable reactions to medicines
Based on part four of article 13 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", 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 submission of information on the revealed undesirable reactions to medicines it (is applied).
the resolution of the Ministry of Health of the Republic of Belarus 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" (The national register of legal acts of the Republic of Belarus, 2008, No. 92, 8/18478);
the resolution of the Ministry of Health of the Republic of Belarus of November 18, 2008 No. 196 "About modification and amendments in the resolution of the Ministry of Health of the Republic of Belarus of March 20, 2008 No. 52" (The national register of legal acts of the Republic of Belarus, 2009, No. 27, 8/19937);
the resolution of the Ministry of Health of the Republic of Belarus of November 13, 2009 No. 121 "About entering of amendments and changes into the resolution of the Ministry of Health of the Republic of Belarus of March 20, 2008 No. 52" (The national register of legal acts of the Republic of Belarus, 2009, No. 288, 8/21612).
3. This resolution becomes effective since May 21, 2015.
First Deputy Minister
D.L.Pinevich
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 48
1. This Instruction determines procedure for submission by health and pharmaceutical workers of information on the revealed undesirable reactions to the medicines which are in circulation in the territory of the Republic of Belarus (further - information on undesirable reactions to 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" and also the following terms and their determinations are used:
probable cause and effect relationship between undesirable reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of undesirable reaction are connected on time with medicine acceptance have low probability of explanation availability of associated diseases or at the same time accepted other medicines, decrease after the medicine acceptance termination;
possible cause and effect relationship between undesirable reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of undesirable 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 undesirable reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of undesirable reaction are connected on time with medicine acceptance cannot be explained with availability of associated diseases or at the same time accepted other medicines, decrease after the termination of acceptance of medicine and arise in case of repeated acceptance of this medicine, can have pharmacological explanation;
the medicine which is subject to additional monitoring - medicine for which at stage of state registration or in case of accomplishment of review of ratio "advantage risk" is determined need of expanded data collection by safety with submission of information on all suspected undesirable reactions;
adverse ratio "advantage risk" for medicine (further - adverse ratio) - the characteristic of medicine testimonial of excess of risk of development of undesirable reactions over the expected therapeutic efficiency of medicine;
cause and effect relationship assessment between undesirable reaction and acceptance of medicine - determination of probability that the accepted medicine was the reason of development established undesirable reaction;
the suspected medicine - medicine between which acceptance and development of undesirable reaction cause and effect relationship availability is suspected;
the suspected undesirable reaction - undesirable reaction in case of which cause and effect relationship between acceptance of medicine and development of undesirable reaction is at least possible;
profile of safety of medicine - set of all undesirable reactions which can develop in case of use of medicine;
the cause and effect relationship between undesirable reaction and acceptance of medicine which is not subject to classification - cause and effect relationship which cannot be estimated because of insufficient or unreliable information and is absent possibility of refining or receipt of missing information;
serious undesirable reactions - undesirable 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 prolongation of finding of the patient in stationary conditions, or lead to the permanent or expressed restrictions of working capacity (disability), to congenital anomaly (malformation), or require medical intervention for prevention of development of the listed conditions;
doubtful cause and effect relationship between undesirable reaction and acceptance of medicine - cause and effect relationship in case of which clinical manifestations of symptoms of undesirable 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;
conditional cause and effect relationship between undesirable reaction and acceptance of medicine - the cause and effect relationship characterizing undesirable reaction which assessment requires receipt of the additional information about undesirable reaction and (or) about the patient accepting this medicine, or information analysis about the revealed undesirable reaction it is not ended at the time of cause and effect relationship assessment between undesirable reaction and acceptance of medicine.
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