UNOFFICIAL TRANSLATION

	APPROVED
Order of the Director of the Republican Unitary Enterprise "Center for Examinations and Tests in Health Service"
No. 17 dated 21.01.2022

PRICE LIST No. 4

for a set of preliminary technical works related to performance of expert examinations prior to the state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of drug products, state registration, conventional state registration of a strategically important drug product, state registration of a drug substance   and introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus; for technical support of maintaining the State Register of Medicinal Products of the Republic of Belarus; for obtaining a permit for import and (or) export of psychotropic substances and their precursors restricted to be carried across the border of the Republic of Belarus for non-economic reasons; for performance of expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and to be used as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and for clinical studies (trials) into the territory of the Republic of Belarus

S. No.	
Service description	
Unit	Tariff excluding VAT, in USD	
1	2	3	4	
1.	Primary expert examination 	 	 	
1.1.	Primary expert examination of documents for state registration (confirmation of state registration) of a drug product, conventional state registration (confirmation of conventional state registration) of a drug product, state registration, conventional state registration of a strategically important drug product manufactured in the Republic of Belarus	Service	158,0	
1.2.	Primary expert examination of documents for state registration of a drug substance manufactured in the Republic of Belarus, a drug substance of foreign manufacture submitted for state registration by a legal entity of the Republic of Belarus having a special permit (licence) for pharmaceutical activities	Service	143,0	
1.3.	Primary expert examination of documents for state registration (confirmation of state registration) of a drug product, conventional state registration (confirmation of conventional state registration) of a drug product, state registration, conventional state registration of a strategically important drug product of foreign manufacture	Service	158,0	
1.4.	Primary expert examination of documents for state registration of a drug substance of foreign manufacture	Service	143,0	
1.5.	 Primary expert examination of documents for introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus 	Service	120,0	
2.	Specialised expert examination		 	
2.1.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of a drug product, state registration, conventional state registration of a strategically important drug product manufactured in the Republic of Belarus (original, biosimilar, immunobiological, biotechnological products)	Service	882,0	
2.1.1.	 Chemical and pharmaceutical expert examination	Service	2 408,0	
2.1.2.	 Pharmacological expert examination	Service	1 998,0	
2.1.3.	 Additionally for every second and every other dosages	Service	1 079,0	
2.1.4.	Additionally for every second and every other dispensing	Service	215,0	
2.1.5.	 Pharmacological expert examination by external experts	Service	981,0	
2.1.6.	 Chemical and pharmaceutical expert examination by external experts	Service	957,0	
2.2.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration), state registration, conventional state registration of a strategically important drug product  of an original, biosimilar, immunobiological, biotechnological drug product manufactured in the Republic of Belarus on a contract basis (dispensing and (or) packaging)	Service	868,0	
2.2.1.	Chemical and pharmaceutical expert examination	Service	1 841,0	
2.2.2.	 Pharmacological expert examination	Service	1 998,0	
2.2.3.	Additionally for every second and every other dosages	Service	1 079,0	
2.2.4.	 Additionally for every second and every other dispensing	Service	215,0	
2.2.5.	 Pharmacological expert examination by external experts	Service	981,0	
2.2.6.	 Chemical and pharmaceutical expert examination by external experts	Service	957,0	
2.3.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of a reproduced (generic), hybrid drug product, state registration, conventional state registration of a strategically important drug product  manufactured in the Republic of Belarus	Service	881,0	
2.3.1.	 Chemical and pharmaceutical expert examination	Service	903,0	
2.3.2.	 Pharmacological expert examination	Service	1 005,0	
2.3.3.	Additionally for every second and every other dosages	Service	956,0	
2.3.4.	Additionally for every second and every other dispensing	Service	190,0	
2.3.5.	 Pharmacological expert examination by external experts	Service	494,0	
2.3.6.	 Chemical and pharmaceutical expert examination by external experts	Service	470,0	
2.4.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of a reproduced (generic), hybrid drug product, state registration, conventional state registration of a strategically important drug product  manufactured in the Republic of Belarus on a contract basis (dispensing and (or) packaging)	Service	881,0	
2.4.1.	 Chemical and pharmaceutical expert examination	Service	903,0	
2.4.2.	 Pharmacological expert examination	Service	1 005,0	
2.4.3.	Additionally for every second and every other dosages	Service	956,0	
2.4.4.	Additionally for every second and every other dispensing	Service	190,0	
2.4.5.	Pharmacological expert examination by external experts	Service	494,0	
2.4.6.	Chemical and pharmaceutical expert examination by external experts	Service	470,0	
2.5.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of a drug product, state registration, conventional state registration of a strategically important drug product  of foreign manufacture (original, biosimilar, immunobiological, biotechnological products)	Service	868,0	
2.5.1.	Chemical and pharmaceutical expert examination	Service	1 841,0	
2.5.2.	Pharmacological expert examination	Service	1 998,0	
2.5.3.	Additionally for every second and every other dosages	Service	1 079,0	
2.5.4.	Additionally for every second and every other dispensing	Service	215,0	
2.5.5.	Pharmacological expert examination by external experts	Service	981,0	
2.5.6.	Chemical and pharmaceutical expert examination by external experts	Service	957,0	
2.6.	Specialised expert examination of documents for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of a reproduced (generic), hybrid drug product, state registration, conventional state registration of a strategically important drug product  of foreign manufacture	Service	880,0	
2.6.1.	Chemical and pharmaceutical expert examination	Service	903,0	
2.6.2.	Pharmacological expert examination	Service	1 005,0	
2.6.3.	Additionally for every second and every other dosages	Service	956,0	
2.6.4.	Additionally for every second and every other dispensing	Service	190,0	
2.6.5.	Pharmacological expert examination by external experts	Service	494,0	
2.6.6.	Chemical and pharmaceutical expert examination by external experts	Service	470,0	
2.7.	Specialised expert examination of documents for state registration of a drug substance manufactured in the Republic of Belarus	Service	701,0	
2.7.1.	Expert examination of documents by experts	Service	556,0	
2.7.2.	Expert examination of documents by external experts	Service	289,0	
2.8.	Specialised expert examination of documents for state registration of a drug substance of foreign manufacture	Service	701,0	
2.8.1.	Expert examination of documents by experts	Service	556,0	
2.8.2.	Expert examination of documents by external experts	Service	289,0	
2.9.	Expert examination of documents for state registration of a drug substance of foreign manufacture submitted for state registration by a legal entity of the Republic of Belarus having a special permit (licence) for pharmaceutical activities	Service	689,0	
2.9.1.	Expert examination of documents by experts	Service	278,0	
2.9.2.	Expert examination of documents by external experts	Service	145,0	
2.10.	Expert examination of documents for introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus	 	 	
2.10.1.	Arrangement of works for the expert examination of documents for introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus 	Service	517,0	
2.10.2.	Expert examination of documents in case of a new indication and (or) new method of administration are added to the summary of product characteristics, the instruction on medical use of a drug product and (or) the package leaflet 		 	
2.10.2.1.	Expert examination of documents by experts	one expert examination of documents by one expert	552,0	
2.10.2.2.	 Expert examination of documents by external experts	one expert examination of documents by one expert	271,0	
2.10.3. 	Expert examination of documents in case of exclusion of previously provided indications on medical use and (or) method of administration from the summary of product characteristics, the instruction on medical use of a drug product and (or) the package leaflet, and in case of introduction of amendments to the pharmacological and clinical sections of the summary of product characteristics, the instruction on medical use of a drug product and (or) the package leaflet 	 	 	
2.10.3.1.	Expert examination of documents by experts	one expert examination of documents by one expert	552,0	
2.10.3.2.	Expert examination of documents by external experts	one expert examination of documents by one expert	271,0	
2.10.4. 	Expert examination of documents in case of introduction of amendments to the sections of the instruction on medical use of a drug product and (or) the package leaflet, except for pharmacological and clinical sections	one expert examination of documents by one expert	147,0	
2.10.5. 	Expert examination of documents in case of introduction of amendments to the formulation of a medicinal product (replacement or introduction of an additional manufacturer of a drug substance, introduction, exclusion or replacement of excipients)	 	 	
2.10.5.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	417,0	
2.10.5.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.6.	Expert examination of documents in case of introduction of amendments to the section “Composition” of a drug master file (if the amendments do not effect the actual composition of the drug product)	 	 	
2.10.6.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	139,0	
2.10.6.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.7.	Expert examination of documents in case of introduction of amendments to the quality regulatory document (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance) when changing the quality indicators, control methods, test procedures	 	 	
2.10.7.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	278,0	
2.10.7.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.7.3.	Chemical and pharmaceutical expert examination by external experts	one expert examination of documents by one expert	145,0	
2.10.8. 	Expert examination of documents when changing the shelf life of a medicinal product (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance)	 	 	
2.10.8.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	208,0	
2.10.8.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.9. 	Expert examination of documents when changing the storage conditions of a medicinal product (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance)	 	 	
2.10.9.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	208,0	
2.10.9.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.10.	Expert examination of documents for introduction of amendments to the master file when submitting an updated draft of a quality regulatory document (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance) in case of changing the quality indicators, control methods, test procedures	 	 	
2.10.10.1.	Expert examination of documents by experts	one expert examination of documents by one expert	441,0	
2.10.10.2.	 Expert examination of documents by external experts	one expert examination of documents by one expert	217,0	
2.10.11. 	Expert examination of documents when changing the materials, type of primary package, components of a medicinal product package (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance)	 	 	
2.10.11.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	77,0	
2.10.11.2.	Pharmacological expert examination	one expert examination of documents by one expert	82,0	
2.10.12.	Expert examination of documents when introducing amendments to the manufacturing process of a medicinal product (including without limitation when the documents of the drug substance manufacturer are contained by the master file of the drug product comprising this drug substance)	 	 	
2.10.12.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	278,0	
2.10.12.2.	Pharmacological expert examination	one expert examination of documents by one expert	221,0	
2.10.13. 	Expert examination of documents for introduction of amendments to the design of the primary, and(or) secondary, and(or) intermediate packaging (if any) dummies for the drug product or introduction of additional primary, and(or) secondary, and(or)  intermediate packaging (if any) dummies with other design	one expert examination of documents by one expert	74,0	
2.10.14.	Expert examination of documents when changing the number of doses in the primary, and(or) secondary, and(or) intermediate packaging of the drug product or the amount of a drug substance in the drug substance packaging	 	 	
2.10.14.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	69,0	
2.10.14.2.	Pharmacological expert examination	one expert examination of documents by one expert	74,0	
2.10.15.	Expert examination of documents for when changing the medicinal product name, pharmaceutical form name, dose indication method (for a medicinal product)	 	 	
2.10.15.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	139,0	
2.10.15.2.	Pharmacological expert examination	one expert examination of documents by one expert	147,0	
2.10.16.	Expert examination of documents during reorganisation and(or) variation of the name and(or) address without changing the actual location of the medicinal product manufacturer, applicant and(or) marketing authorisation holder, including without limitation when the documents of the drug substance manufacturer are contained in the drug master file	 	 	
2.10.16.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	139,0	
2.10.16.2.	Pharmacological expert examination	one expert examination of documents by one expert	147,0	
2.10.17.	Expert examination of documents when changing the manufacturer, manufacturing country (replacement or addition of a new manufacturing site for a part of or all manufacturing processes – for drug products, replacement or addition of a new manufacturing site for a part of the manufacturing processes – for drug substances) of a drug product, including without limitation when the documents of the drug substance manufacturer are contained in the drug master file	 	 	
2.10.17.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	278,0	
2.10.17.2.	Pharmacological expert examination	one expert examination of documents by one expert	270,0	
2.10.18.	Expert examination of documents for when changing the medicinal product applicant and (or) the marketing authorisation holder	 	 	
2.10.18.1.	Chemical and pharmaceutical expert examination	one expert examination of documents by one expert	139,0	
2.10.18.2.	Pharmacological expert examination	one expert examination of documents by one expert	74,0	
2.10.19.	Expert examination of documents when changing the design of the certificate/quality certificate (design certificate) for a medicinal product	one expert examination of documents by one expert	74,0	
3.	Expert examination of documents on the possibility of issuing authorisations for import and (or) export of psychotropic substances and their precursors restricted to be carried across the state border of the Republic of Belarus for non-economic reasons	Service	154,0	
4.	Expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and use as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and for clinical studies (trials) to the territory of the Republic of Belarus	Service	125,0	

Note:

1.	The tariffs of this price list are valid in the territory of the Republic of Belarus and apply to the services rendered by the Centre for Examinations and Tests in Health Service Republican Unitary Enterprise for a set of preliminary technical works related to performance of expert examinations  of documents prior to the state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of drug products, state registration, conventional state registration of a strategically important drug product, state registration of a drug substance   and introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus; for technical support of maintaining the State Register of Medicinal Products of the Republic of Belarus; for obtaining a permit for import and (or) export of psychotropic substances and their precursors restricted to be carried across the border of the Republic of Belarus for non-economic reasons; for performance of expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and to be used as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and for clinical studies (trials) into the territory of the Republic of Belarus, for non-resident applicants of the Republic of Belarus.

2.	The tariffs of this price list are differentiated according to the groups of medicinal products and the complexity of the expert examination of the documents submitted for review.

3.	The cost of chemical, toxicological, clinical (medical) trials, bioequivalent and other studies, materials, auxiliary works and services required for performance of a set of services prior to state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) state registration, conventional state registration of a strategically important drug product, state registration of drug substances, introduction of amendments to the master file of medicinal products previously registered in the Republic of Belarus, in accordance with the attached characteristics of the work, is to be additionally paid by the applicant at the rates approved in the prescribed manner.

4.	The state tax to the state budget for state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of drug products and state registration of drug substances, state registration, conventional state registration of a strategically important drug product is charged additionally in the order and in accordance with the current legislation of the Republic of Belarus.

5.	When carrying out expert examination of documents for introduction of amendments to the master file for a drug product (drug substance) previously registered in the Republic of Belarus, an additional fee in the amount of 10 % of the tariff stipulated by subclauses 2.10.13., 2.10.14. of the price list is charged for the second and each subsequent packaging, dosage.

6.	When carrying out a set of preliminary technical works related to expert examination of documents prior to confirmation of state registration, confirmation of conventional state registration of drug products, a fee in the amount of 50 % of the tariff stipulated by subclauses 2.1.1., 2.1.6., 2.2.1., 2.2.6., 2.3.1., 2.3.6., 2.4.1., 2.4.6., 2.5.1., 2.5.6., 2.6.1, 2.6.6. of clause 2 of the price list is charged.

7.	When carrying out expert examination of documents for a drug product, a drug substance previously registered in the Republic of Belarus, when changing the name of a drug product, a drug substance or a manufacturer, changing the manufacturer (manufacturing country), changing the registration for other plants of the same company for the second and each subsequent dispensing and dosage, an additional fee in the amount of 10 % of the tariff provided for in subclauses 2.10.15., 2.10.16., 2.10.17. of the price list is charged.

8.	 Settlements with non-residents for a performed set of preliminary technical works related to performance of expert examinations prior to the state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of drug products, state registration, conventional state registration of a strategically important drug product, state registration of a drug substance and introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus; for technical support of maintaining the State Register of Medicinal Products of the Republic of Belarus; for obtaining a permit for import and (or) export of psychotropic substances and their precursors restricted to be carried across the border of the Republic of Belarus for non-economic reasons; for performance of expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and to be used as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and for clinical studies (trials) into the territory of the Republic of Belarus are carried out in accordance with the current legislation of the Republic of Belarus on currency regulations.

9.	For the expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and use as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and intended for clinical studies (trials) to the territory of the Republic of Belarus, an additional fee on the amount of 5 % of the tariff stipulated in clause 4 of the price list is charged for the second and each subsequent drug product (drug substance) within one approval.

10.	Upon the order of the Ministry of Health of the Republic of Belarus, a set of preliminary technical works related to performance of expert examinations prior to the state registration, conventional state registration (confirmation of state registration, confirmation of conventional state registration) of drug products, state registration, conventional state registration of a strategically important drug product, state registration of a drug substance and introduction of amendments to the master file of a medicinal product previously registered in the Republic of Belarus; for technical support of maintaining the State Register of Medicinal Products of the Republic of Belarus; for obtaining a permit for import and (or) export of psychotropic substances and their precursors restricted to be carried across the border of the Republic of Belarus for non-economic reasons; for performance of expert examination of documents on the possibility of issuing conclusions (approvals) for import of unregistered medicinal products intended for state registration and to be used as exhibition samples without the right of further sell; of registered and unregistered medicinal products intended for non-clinical studies, confirmation of state registration without the right of further sell and for clinical studies (trials) of certain medicinal products into the territory of the Republic of Belarus may be carried out free of charge.

11.	 When carrying out expert examination of documents for introduction of amendments to the master file (including without limitation when the documents of the drug substance manufacturer are contained in the drug master file) in cases not requiring submission of a document package in accordance with the legislation of the Republic of Belarus, a fee in the amount of 10 % of the tariff specified in subclauses 2.10.7, 2.10.9., 2.10.11., 2.10.14. of clause 2 of the price list.

12.	 When carrying out an expedited procedure of expert examination of documents for introduction of amendments to the master file of a drug product (drug substance) previously registered in the Republic of Belarus, when charging a fee to the tariffs stipulated in clause 1.5., subclauses 2.10.1., 2.10.3., 2.10.4., 2.10.6., 2.10.8., 2.10.9., 2.10.11., 2.10.13., 2.10.14., 2.10.15., 2.10.16., 2.10.18. of the price list, a coefficient 2 is applied.

13.	When carrying out a set of preliminary technical works related to expert examination of documents prior to confirmation of state registration of drug products having two or more flavours (flavouring agents), in case of submission of several applications and one master file (document package), an additional fee in the amount of 20 % of the tariff provided for in subclauses 2.1., 2.2., 2.3., 2.4., 2.5., 2.6., of clause 2 of the price list is charged for the second and each subsequent flavour (flavouring agent).