RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS
April 17, 2015 No. 48
On the procedure for submitting information on detected adverse reactions to medicinal products
Amendments and additions:
Resolution of the Ministry of Health of the Republic of Belarus No. 87 dated October 23, 2020 (registered in the National Register - No. 8/36091 dated 30.11.2020) <W22036091>
 
Pursuant to the part four of Article 13 of the Law of the Republic of Belarus No. 161-Z dated July 20, 2006 "On the Circulation of Medicinal Products", subparagraph 9.1 of paragraph 9 of the Regulations on the Ministry of Health of the Republic of Belarus, approved by Resolution of the Council of Ministers of the Republic of Belarus No. 1446 dated October 28, 2011, the Ministry of Health of the Republic of Belarus RESOLVES:
1. Approve the Instructions on the procedure for submitting information on identified adverse reactions to medicinal products (attached).
2. Declare to be no longer in force:
Resolution of the Ministry of Health of the Republic of Belarus No. 52 dated March 20, 2008 "On approval of the Instructions on the procedure for submitting information on identified adverse reactions to medicinal products and monitoring adverse reactions to medicinal products" (National Register of Legal Acts of the Republic of Belarus, 2008, No. 92, 8/18478);
Resolution of the Ministry of Health of the Republic of Belarus No. 196 dated November 18, 2008 "On Amendments and Additions to the Resolution of the Ministry of Health of the Republic of Belarus No. 52 dated March 20, 2008" (National Register of Legal Acts of the Republic of Belarus, 2009, No. 27, 8/19937);
Resolution of the Ministry of Health of the Republic of Belarus No. 121dated November 13, 2009 "On making additions and amendments to the Resolution of the Ministry of Health of the Republic of Belarus No. 52 dated March 20, 2008" (National Register of Legal Acts of the Republic of Belarus, 2009, No. 288, 8/21612).
3. This Resolution comes into force on May 21, 2015.
 
First Deputy Minister	D. L. Pinevich	

 	APPROVED
Resolution
 of the Ministry of Health 
of the Republic of Belaru
s No. 48 dated 17.04.2015
 (as amended by the Resolution of 
the Ministry of Health 
of the Republic of Belarus 
No. 87 dated 23.10.2020)	
INSTRUCTIONS
 on the procedure for submitting information on identified adverse reactions to medicinal products
1. These Instructions define the procedure for submitting information on identified adverse reactions to medicinal products in circulation on the territory of the Republic of Belarus by medical and pharmaceutical professionals (hereinafter – information on adverse reactions to medicinal products).
2. The main terms and their definitions in the meanings established by the Law of the Republic of Belarus "On the Circulation of Medicinal Products" are used in these Instructions, as well as the following terms and their definitions:
probable causal relationship between an adverse reaction and taking a medicinal product is a causal relationship in which the clinical manifestations of symptoms of an adverse reaction are related in time to taking a medicinal product, have a low probability of being explained by the presence of concurrent diseases or simultaneously taken other medicinal products, decrease after discontinuation of taking the medicinal product;
possible causal relationship between an adverse reaction and taking a medicinal product is a causal relationship in which the clinical manifestations of the symptoms of an adverse reaction are related in time to taking a medicinal product, can be explained by the presence of concurrent diseases or simultaneously taken medicinal products, information about the results of discontinuation of taking the medicinal product is missing or unreliable;
certain causal relationship between an adverse reaction and taking a medicinal product is a causal relationship in which the clinical manifestations of symptoms of an adverse reaction are related in time to taking a medicinal product, cannot be explained by the presence of concurrent diseases or other medicinal products taken simultaneously, decrease after discontinuation of taking a medicinal product and occur when taking this medicinal product again, may have a pharmacological explanation;
medicinal product subject to additional monitoring is a medicinal product for which, at the stage of state registration or when performing a revision of the risk-benefit balance, the need for expanded collection of safety data with information on all suspected adverse reactions has been determined;
unfavorable risk-benefit balance for the medicinal product (hereinafter referred to as the unfavorable balance) - characteristics of the medicinal product, indicating that the risk of developing adverse reactions exceeds the expected therapeutic effectiveness of the medicinal product;
causality assessment of an adverse reaction and taking a medicinal product - determining the probability that the medicinal product being taken was the cause of the development of the identified adverse reaction;
suspected medicinal product – a medicinal product, between the intake of which and the development of an adverse reaction, the presence of a causal relationship is suspected;
suspected adverse reaction is an adverse reaction in which a causal relationship between taking a medicinal product and the development of an adverse reaction is at least possible;
safety profile of a medicinal product is a set of all adverse reactions that can develop when using a medicinal product;
unclassifiable causal relationship between an adverse reaction and taking a medicinal product is a casual relationship that cannot be evaluated due to insufficient or unreliable information and there is no possibility of clarifying or obtaining missing information;
serious adverse reactions – adverse reactions that, regardless of the dose of the medicinal product taken, result in death, are life-threatening, require hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability (incapacity), or lead to a congenital anomaly (birth defect), or require medical intervention to prevent the development of these conditions;
unlikely causal relationship between an adverse reaction and taking a medicinal product is a causal relationship in which the clinical manifestations of the symptoms of an adverse reaction are not clearly related in time to taking a medicinal product and can be explained by the presence of concurrent diseases or other medical products taken simultaneously;
conditional causal relationship between an adverse reaction and taking a medicinal product is a causal relationship that characterizes an adverse reaction, the assessment of which requires additional information about the adverse reaction and (or) about the patient who took this medicinal product, or the analysis of information about the detected adverse reaction is not completed at the time of assessing the causal relationship between the adverse reaction and taking the medicinal product.
3. Medical and pharmaceutical professionals submit information about adverse reactions to medicinal products to the Republican Unitary Enterprise "Center for Examinations and Tests in Health Service" (hereinafter referred to as the "Center for Examinations and Tests in Health Service") in electronic form or on paper in accordance with the Annex. Information about adverse reactions to medicinal products can also be sent to the marketing authorisation holders.
4. The Republican Unitary Enterprise "Center for Examinations and Tests in Health Service" receives, records and evaluates information about adverse reactions to medicinal products received in accordance with paragraph 3 of these Instructions, as well as in the case of receipt of such information from the marketing authorisation holder in accordance with the Guideline on good pharmacovigilance practices of the Eurasian Economic Union.
5. Medical and pharmaceutical professionals provide information about adverse reactions in all cases of:
detection of serious adverse reactions of the medicinal product;
detection of unexpected adverse reactions of the medicinal product;
detection of adverse reactions, the cause of which is assumed to be a quality defect of the medicinal product;
the lack of the expected therapeutic efficacy of the medicinal product;
the development of adverse reactions when using medicinal products according to the procedure for ensuring early access of patients to new treatment methods;
the development of adverse reactions when using medicinal products that are subject to additional monitoring.
6. The heads of organizations engaged in medical and pharmaceutical activities ensure that medical and pharmaceutical professionals fulfill their duties to submit information about detected adverse reactions to medicinal products to the Republican Unitary Enterprise "Center for Examinations and Tests in Health Service".
7. Information about adverse reactions to medicinal products is provided by medical and pharmaceutical professionals in the following terms:
up to 3 calendar days from the date of detection of serious adverse reactions of the medicinal product;
up to 3 calendar days from the date of detection of adverse reactions, the cause of which is assumed to be a quality defect of the medicinal product;
up to 10 calendar days from the date of detection of adverse reactions specified in paragraphs three, five–seven of clause 5 of these Instructions.
8. The Republican Unitary Enterprise "Center for Examinations and Tests in Health Service", when analyzing the information provided on adverse reactions to medicinal products, if necessary, requests additional information from medical and pharmaceutical professionals about adverse reactions to medicinal products. In this case, the requested information shall be provided no later than 14 calendar days from the date of receipt of the written request.
9. According to the results of the analysis of the information provided on adverse reactions to medicinal products, the Republican Unitary Enterprise "Center for Examinations and Tests in Health Service" sends to the State Institution "State Pharmaceutical Supervision in the sphere of medicines circulation "Gosfarmnadzor" for taking measures in accordance with the established procedure:
a written report on the identification of a suspicion that the quality defect causes the development of adverse reactions and (or) the lack of therapeutic efficacy within a period not exceeding 72 hours;
a written report on the identification of a suspicion of an unfavorable change in the risk-benefit balance during the medical use of the medicinal product within a period not exceeding 72 hours;
written information on the detection of an unfavorable change in the risk-benefit balance during the medical use of the medicinal product within a period  not exceeding 24 hours.

 
 	Annex
to the Instructions on the procedure
 for submitting information 
on identified adverse
 reactions to medicinal products 
(as amended by the Resolution of 
the Ministry of Health of the 
Republic of Belarus
 No. 87 dated 23.10.2020) 	
 
Form
Notification of an adverse reaction to a medicinal product
A medical or pharmaceutical professional who reports an adverse reaction: 
 Surname, first name, patronymic (if any): 
 Phone number:
 Position and place of work:
 Location of the organization:  	Patient Information
 Initials: 
 Medical card number ______________________ 
 Gender: □ M □ F 
 Age: _____ Weight (kg): ________ 
 Impaired liver function: 
□ yes □ no □ unknown
 Impaired renal function: 
□ yes □ no □ unknown 
Allergy history (indicate to what): 	
Use of the medicinal product: 
□ inpatient, 
□ outpatient, 
□ self-treatment 
Report: □ initial
              □ follow up to report from ___________________________
(initial report date)		
SUSPECTED MEDICINAL PRODUCT	
International nonproprietary name	 	Brand name	 	
Manufacturer	 	Batch number	 	
Indication for use (diagnosis)	Route of administra
tion	Single dose	Frequency of administration	Start date of therapy	End date of therapy	
 	 	 	 	/   /	/   /	
CONCOMITANT MEDICINAL PRODUCTS 
(specify "NO" if the patient has not taken any other medicinal products)	
International nonproprietary name or brand name of a medicinal product	Indication 
for use
(diagnosis)	Route of administra
tion	Single dose	Frequency of administration
	Start date of therapy	End date of therapy	
 	 	 	 	 	/   /	/   /	
 	 	 	 	 	/   /	/   /	
 	 	 	 	 	/   /	/   /	
 	 	 	 	 	/   /	/   /	
Description of the suspected adverse reaction: 	Date of the beginning of the adverse reaction:
 ___/___/ __________ 
The end date of the adverse reaction:
 ___/___/_________	
Result of dechallenge of the suspected medicinal product:
□ obvious improvement 
□ no improvement 
□ not discontinued 
□ unknown 
□ not applicable	Concurrent diseases, other conditions or risk factors:	
Causality assessment: 
□ certain
□ probable 
□ possible 
□ unlikely 
□ conditional 
□ unclassifiable	Outcome: 
□ recovered without sequelae 
□ recovering
□ recovered with  sequelae 
 (specify) _________________________________ 
□ condition unchanged (not recovered yet) 
□ death may be associated with an adverse reaction 
□ death is not associated with an adverse reaction
 □ outcome is not known	
Measures taken: 
□ without treatment 
□ withdrawal of the suspected medicinal product 
□ reduction of the dose of the suspected medicinal product 
□ withdrawal of concomitant treatment 
□ pharmacological therapy 
□ non-pharmacological treatment (including surgery)
 □ other, specify ________________________________________
________________________________________________
________________________________________________	Medicinal products used to stop an adverse reaction (if required) 
	
Criteria for classifying serious adverse reactions (indicate if appropriate): 
□ death 
□ life-threatening
□ requires inpatient hospitalization or prolongation of existing hospitalization 
□ congenital anomalies 
□ disability/incapability 
□ the need for medical intervention to prevent the above conditions 
□ not applicable	Has there been a recurrence of an adverse reaction after rechallenge of the medicinal product: 
□ reoccurence of an adverse reaction 
□ no adverse reaction 
□ no rechallenge 
□ no adverse reaction when reducing the dose 
□ unknown

The suspected medicinal product is used in: 
□ medical practice 
□ clinical trials (number of the clinical trial protocol)
 _________________________________________________________________________________________	
Important additional information 
Data from clinical, laboratory, X-ray studies and autopsy, including determination of the concentration of medicinal products in the blood (tissues), if any, and associated with an adverse reaction (indicate dates):
__________________________________________________________________________________________
_____________________________________
__________________________________________________________________________________________
Anamnestic data: ________________________________________________________________
__________________________________________________________________________________________
____________________________________________________________________________________________
Suspected drug interactions: _____________________________________________
 _______________________________________________________________________________________
________________________________________________________________________________________
For congenital anomalies, specify all other medicinal products taken during pregnancy, as well as the date of the last menstruation: 
______________________________________________________________________________________ 
______________________________________________________________________________________
______________________________________________________________________________________
Additional pages are attached, if necessary.	
 
______________ __ , 20__ 	__________________	
 	(signature)