APPROVED	
Order of Deputy Director of Unitary Enterprise “Center for Examinations and Tests in Health Service”	
No. 280 dated 02.08.2023
(as revised by the Order
No. 315 dated 25.08.2023)	

Price-list
for a set of expert examinations to be carried out when making changes to the registration dossier of a registered medicinal product for medical use within the framework of the Eurasian Economic Union

No.	Name of product (work, service)	Unit	Price excluding VAT for:	
			residents of the Republic of Belarus
(BYN)	non-residents of the Republic of Belarus (USD)	
1.	Organization of work during amendments to the registration dossier	One set of documents 	555.64	290	
2.	Expert examination of documentation during amendments to the registration dossier (participation of the Republic of Belarus as a Reference State) 	
2.1.	Expert examination of documents on quality aspects 	
2.1.1.	Expert examination in case of insignificant changes of type IA	One set of documents	548.73	181	
2.1.2.	Expert examination in case of insignificant changes of type IB	One set of documents	1 004.05	331	
2.1.3.	Expert examination in case of significant changes of type II	One set of documents	1 284.25	423	
2.1.4.	Expert examination in case of the extension of registration	One set of documents	2 405.05	793	
2.2.	Expert examination of documents on preclinical and clinical aspects	
2.2.1.	Expert examination in case of insignificant changes of type I (IA, IB)	One set of documents	1 206.38	398	
2.2.2.	Expert examination in case of significant change of type II, which, while not a change requiring a new registration, may have a significant effect on quality, safety or efficacy. Requires submission of clinical or preclinical data	One set of documents	3 939.20	1 298	
2.2.3.	Expert examination in case of significant change of type II that does not affect existing data from clinical and preclinical studies, or does not involve the submission of new data in principle	One set of documents	2 757.44	909	
2.2.4.	Expert examination in case of the extension of registration requiring the submission of clinical or preclinical data	One set of documents	3 939.20	1 298	
2.2.5.	Expert examination in case of the extension of registration that does not affect existing data from clinical and preclinical studies, or does not involve the submission of new data in principle	One set of documents	2 757.44	909	
3.	Expert examination of documentation during amendments to the registration dossier (participation of the Republic of Belarus as a Concerned State).	
3.1.	Expert examination of documents on quality aspects	
3.1.1.	Expert examination in case of insignificant changes of type IA	One set of documents	373.60	123	
3.1.2.	Expert examination in case of insignificant changes of type IB	One set of documents	653.80	215	
3.1.3.	Expert examination in case of significant changes of type II	One set of documents	793.90	262	
3.1.4.	Expert examination in case of the extension of registration	One set of documents	1 844.65	608	
3.2.	Expert examination of documents on preclinical and clinical aspects	
3.2.1.	Expert examination in case of insignificant changes of type I (IA, IB)	One set of documents	1 206.38	398	
3.2.2.	Expert examination in case of significant change of type II, which, while not a change requiring a new registration, may have a significant effect on quality, safety or efficacy. Requires submission of clinical or preclinical data	One set of documents	2 757.44	909	
3.2.3.	Expert examination in case of significant change of type II that does not affect existing data from clinical and preclinical studies, or does not involve the submission of new data in principle	One set of documents	2 166.56	714	
3.2.4.	Expert examination in case of the extension of registration requiring the submission of clinical or preclinical data	One set of documents	2 757.44	909	
3.2.5.	Expert examination in case of the extension of registration that does not affect existing data from clinical and preclinical studies, or does not involve the submission of new data in principle	One set of documents	2 166.56	714	

Note:
1. The prices of this price-list are valid in the territory of the Republic of Belarus.
2. Settlements with non-residents of the Republic of Belarus for services (works) rendered (performed) in accordance with this price-list are made in accordance with legislation of the Republic of Belarus on currency regulation.
3. The cost of chemical, toxicological, clinical (medical) tests, bioequivalent and other studies, auxiliary works and services required for the complex of expert examinations carried out when making changes to the registration dossier of a registered medicinal product for medical use within the framework of the Eurasian Economic Union in accordance with the attached details of works shall be paid by the applicant additionally according to the prices approved in the established procedure.
4. When submitting a collective application for amendments to the registration dossier, the expert examination of documents on quality aspects and examination of documents on preclinical and clinical aspects shall be charged at the rate of 100 % of the highest price for each type of examination, established by subclauses 2. 1., 2.2. (3.1., 3.2.) of this price-list, and for the expert examination of documents for each subsequent amendment in the same group a fee of 20% of the price stipulated in subclauses 2.1., 2.2. (3.1., 3.2.) of this price-list shall be charged in addition.

*Example:
1. Collective application for expert examination of documents on quality aspects: (subclause 2.1.1.) expert examination in case of insignificant changes of type IA (548.73 rubles), (subclause 2.1.3.) expert examination in case of significant changes of type II (1284.25 rubles), (subclause 2.1.4.) expert examination in case of the extension of registration (2405.05 rubles).
Calculation (2405,05*100%) +(548,73*20%) +(1284,25*20%)
2.	Collective application for expert examination of documents on quality aspects and expert examination of documents on preclinical and clinical aspects: (subclause 2.1.1.) expert examination in case of insignificant changes of type IA (548,73 rubles), (subclause 2.1.3.) expert examination in case of significant changes of type II (1284,25 rubles), (subclause 2.2.2.) expert examination in case of significant change of type II, which, while not a change requiring a new registration, may have a significant effect on quality, safety or efficacy. Requires submission of clinical or preclinical data (3939,20 rubles), (subclause 2.2.4.) expert examination in case of the extension of registration requiring the submission of clinical or preclinical data (3939,20 rubles).
Calculation
(1284,25*100%) +(548,73*20%) +(3939,20*100%) +(3939,20*20%)
5. By order of the Ministry of Health of the Republic of Belarus, amendments to the registration dossier of a registered medicinal product for medical use in accordance with the requirements of the Eurasian Economic Union for certain names of medicinal products may be made without charging a fee.