RESOLUTION OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS
No. 776 dated October 31, 2018
On Registration of Ex-Works Price Limits for Medicinal Products
In accordance with subclause 2.1, clause 2 of Decree of the President of the Republic of Belarus No. 345 On Registration of Prices for Medicinal Products dated August 22, 2018, the Council of Ministers of the Republic of Belarus RESOLVES AS FOLLOWS:
1. To create a national register of ex-works price limits for medicinal products.
2. To approve the enclosed:
Regulation on the Procedure for Registration of Ex-Works Price Limits for Medicinal Products;
Regulation on the Procedure for Maintenance of the National Register of Ex-Works Price Limits for Medicinal Products.
3. This Resolution shall come into force after its official publication.

Prime-Minister of the Republic of Belarus	S. Rumas	

	APPROVED
Resolution
of the Council of Ministers of the Republic of Belarus
No. 776 dated 31.10.2018	
REGULATION
on the Procedure for Registration of Ex-Works Price Limits for Medicinal Products
1. This Regulation shall establish the procedure for registration of selling price limits of organizations carrying out production of medicinal products (hereinafter – the manufacturers) subject to such registration according to Decree of the President of the Republic of Belarus No. 345 dated August 22, 2018 On Registration of Prices for Medicinal Products (National Legal Internet Portal of the Republic of Belarus, 25.08.2018, 1/17898).
2. For the purposes of this Regulation, the terms and their definitions specified by the Law of the Republic of Belarus On Medicinal Products dated July 20, 2006 (National Register of Legal Acts of the Republic of Belarus, 2006, No. 122, 2/1258) shall be used, as well as terms and their definitions, as follows:
marketing authorization holder – a legal entity or an individual entrepreneur granted a marketing authorization for the medicinal product as prescribed by law;
ex-works price limit (hereinafter – the selling price limit, unless otherwise set forth herein) – the price calculated by method established by the Ministry of Antimonopoly, Regulation and Trade in consultation with the Ministry of Health (hereinafter – the method) restrained by the upper limit and subject to registration.
3. Registration of selling price limits shall be performed by the Ministry of Health (hereinafter – the MH).
Selling price limits shall be registered in belarusian rubles (BYN). No fee shall be charged for selling price limits registration.
4. To register a selling price limit, the marketing authorization holder (its authorized person) shall submit to the Center for Examinations and Tests in Health Service Republican Unitary Enterprise (hereinafter – Center for Examinations and Tests in Health Service RUE) the following documents in duplicate as hard copies:
4.1. declaration of registration of ex-works price limit for a medicinal product in the form specified in the annex (hereinafter – the declaration). The data in the declaration shall comply with the marketing authorization and registration dossier for the medicinal product as of the declaration date;
4.2. documents proving the authority of the submitting person;
4.3. copy of medicinal products manufacturing license;
4.4. copy of marketing authorization for the medicinal product;
4.5. documents filed in accordance with the requirements and in the forms determined by the method;
4.6. list of information sources (web-sites) containing data on ex-works price limits for the medicinal product in the countries listed in the method or other documents proving such selling prices. The specified information sources shall comply with the following requirements:
the information source shall contain data on the organization responsible for publication of prices for medicinal products;
the information on prices for medicinal products provided by international financial organizations (funds) according to the decision of the World Health Organization and (or) determined on the grounds of special agreements on procurement of the medicinal product on condition of documental proof of such agreements shall not be used as information source.
The information published in such sources shall:
be public;
allow for identification of the necessary characteristics of medicinal products with the aim of comparison of data on the medicinal product declared and that which price is stated in the information source used;
contain data on the price for the medicinal product and the currency in which it is specified.
5. Documents submitted for registration of selling price limit in a foreign language shall be presented as hard copies with their duly certified Russian or Belarussian translations.
6. Center for Examinations and Tests in Health Service RUE shall, within five business days as of the declaration date, check the completeness and reliability of the documents submitted in accordance with clause 4 of this Regulation (hereinafter – the documents) and the data contained in them, whereafter shall either forward the documents to the Ministry of Antimonopoly, Regulation and Trade (hereinafter – the MART) and the MH or reject the declaration in case of its non-compliance with the requirements as to its form or failure to submit the documents (data) in full, as well as in case of their non-reliability and (or) non-compliance with the requirements specified in clauses 4 and 5 of this Regulation.
The decision on rejection of a declaration shall be forwarded to a marketing authorization holder (its authorized person) within two business days upon adopting such a decision.
7. Center for Examinations and Tests in Health Service RUE shall provide records management and custody of documents related to registration of selling price limits as prescribed by law.
8. The MART shall, within 10 business days as of the documents submission, carry out the economic analysis of selling price limit calculated by the marketing authorization holder (its authorized person) and shall forward to the MH either the selling price limit approval or its rejection.
To carry out such economic analysis, the MART shall use sources containing data on ex-works price limits for medicinal products in the countries listed in the method. It is understood that such sources shall comply with the requirements specified in subclause 4.6, clause 4 of this Regulation.
To clarify the data contained in the submitted documents or additional information on the MART’s request shall be needed, the government authorities within their competence and (or) medicinal products regulatory authorities shall provide the respective data and information as required by law. it is understood that the term for consideration of documents provided for in the first part of this clause shall be prolonged by no more than 10 business days.
9. The reasons for rejection of selling price limit approval by the MART shall be:
provision of unreliable or incomplete data;
excess of the selling price limit submitted for registration over the price calculated according to the method.
10. The MH shall, within three business days as of the receipt of the selling price limit approval or rejection by the MART, decide on either selling price limit registration or rejection. The decision on selling price limit registration shall be documented as the order of the MH.
11. The reasons for rejection of selling price limit registration by the MH shall be:
provision of unreliable data;
provision of documents and (or) data non-complying with the legal requirements;
rejection of selling price limit approval by the MART.
12. In the event of adoption of decision on selling price limit registration, the MH shall, within two business days, notify the marketing authorization holder (its authorized person), as well as Center for Examinations and Tests in Health Service RUE on selling price limit registration in writing.
Center for Examinations and Tests in Health Service RUE shall, within two business days upon the receipt of the notification described in the first part of this clause, put the respective data on the national register of ex-works price limits for medicinal products and shall publish the respective information on its official web-site and the Internet.
13. In the event of rejection of selling price limit registration, the MH shall, within two business days as of such decision, notify the marketing authorization holder (its authorized person) on its decision (stating the reasons for such rejection) in writing.
14. Decision on selling price limit registration rejection may be appealed against as prescribed by law.
15. For all manufacturers listed in the marketing authorization (manufacturing sites involved in production) a unified selling price limit for a medicinal product shall be registered for each pharmaceutical and dosage form (strength, potency in units of activity; volume, weight, number of doses in primary packaging, if necessary) and total amount in secondary packaging regardless of presentation, with the exception of cases provided for in clause 16 of this Regulation.
16. When minimum selling price of the original medicinal product for various presentations (prefilled syringes, cartridges or other presentations compatible with delivery (administration) devices or being delivery (administration) devices themselves) differs by more than 10 per cent in the countries listed in the method, it shall be acceptable to register selling price limits for each of such presentations of both original and generic (biologically similar) medicinal product.
17. The MH shall forward to the marketing authorization holder (its authorized person) a written notification on the necessity to lower the selling price limit registered according to the procedure established by this Regulation in the following cases:
due to calculation of the selling price limit according to the method on the grounds of data on minimum ex-works prices in the countries listed in the method become lower than the registered selling price limit by more than 5 per cent in the result of lowering of the selling price for the medicinal product in such countries by the manufacturer;
the selling price limit for generic (biologically similar) medicinal product exceed the registered selling price limit for the corresponding original medicinal product.
18. The MH shall revoke the decision on selling price limit registration if:
it is ascertained that the marketing authorization holder (its authorized person) has submitted unreliable data which has influenced the decision;
the marketing authorization holder (its authorized person) fail to bring the registered selling price limit in compliance with the notification described in clause 17 of this Regulation within 45 calendar days as of the notification date;
it is ascertained that the fact of realization on the territory of the Republic of Belarus of a medicinal product, the ex-works price for which exceeds the selling price limit registered according to the procedure established by this Regulation, be elicited.

	Annex
to Regulation on the Procedure for Registration of Ex-Works Price Limits for Medicinal Products	

Form

Ministry of Health
of the Republic of Belarus
DECLARATION
of Registration of Ex-Works Price Limit for a Medicinal Product
Marketing authorization holder
_____________________________________________________________________________
(full name; E-mail)
Person submitting documents for selling price limit registration
_____________________________________________________________________________
(full name of a legal entity; surname, name, patronymic
_____________________________________________________________________________
(if any) of an individual entrepreneur; postal
_____________________________________________________________________________
address; E-mail; contact numbers)

Marketing authorization number	International non-proprietary (generic) name	Manufacturing stage	Manufacturer’s name	Manufacturing site location	
1	2	3	4	5	

ATC code recommended by WHO	Trade name	Pharmaceutical form, completeness*	Dosage form	Amount in secondary packaging	Ex-works price limit for secondary packaging excluding VAT*, BYN	
6	7	8	9	10	11	

______________________________
* In cases provided for in clause 16 of this Regulation, the presentation of the medicinal product shall be additionally stated, considering which the ex-works price limit for secondary packaging of the medicinal product shall be calculated.

Director of a legal entity,
individual entrepreneur	_______________________		________________	
	(initials, surname)		(signature)	
Date _________________				

	APPROVED
Resolution
of the Council of Ministers of the Republic of Belarus
No. 776 dated 31.10.2018	
REGULATION
on the Procedure for Maintenance of the National Register of Ex-Works Price Limits for Medicinal Products
1. This Regulation shall establish the procedure for maintenance of the national register of ex-works price limits for medicinal products (hereinafter – the register) regarding the medicinal products in the list determined by Decree of the President of the Republic of Belarus No. 345 dated August 22, 2018 On Registration of Prices for Medicinal Products (National Legal Internet Portal of the Republic of Belarus, 25.08.2018, 1/17898).
2. For the purposes of this Regulation, the terms and their definitions specified by the Law of the Republic of Belarus On Medicinal Products dated July 20, 2006 (National Register of Legal Acts of the Republic of Belarus, 2006, No. 122, 2/1258) shall be used, as well as terms and their definitions specified by the Regulation on the Procedure for Registration of Ex-Works Price Limits for Medicinal Products approved by the resolution approving this Regulation.
3. The register is a state information resource representing an electronic database, secured from failure and unauthorized access with specialized software, containing the data on ex-works price limits for medicinal products.
4. The register shall be created by the Ministry of Health at the premises of the Center for Examinations and Tests in Health Service Republican Unitary Enterprise (hereinafter – Center for Examinations and Tests in Health Service RUE).
5. Center for Examinations and Tests in Health Service RUE shall carry out development and modernization of the register, provide hard- and software for its maintenance, including automated integration of the data included into the register, its updating, safekeeping and protection, and shall have other powers connected with the maintenance of the register.
6. The maintenance of the register shall be based on the following principles:
completeness and reliability of the data contained in the register;
promptness and accuracy of the data derived from the register;
compliance with organizational, soft- and hardware, as well as methodological requirements.
7. The register shall be maintained in electronic form based on automated system by means of making register entries.
A register entry shall include the following data:
name of marketing authorization holder;
name of the manufacturer of the medicinal product and location of manufacturing sites according to the marketing authorization;
name of the medicinal product (international non-proprietary (generic) and trade names);
number of the marketing authorization;
pharmaceutical form stating the dosage form of the medicinal product and its amount in the secondary package, as well as its completeness;
ex-works price limit for the medicinal product in Belarusian rubles (BYN);
date and number of the order of the Ministry of Health on registration of ex-works price limit for the medicinal product;
the Anatomical, Therapeutic, Chemical Classification System code of the medicinal product recommended by the World Health Organization.
Making the register entry shall be performed on the grounds of the data obtained during registration of ex-works price limit for the medicinal product within three business days as of the date of the decision on such registration.
8. In the event of introduction of amendments to the registration dossier for a medicinal product registered in the Republic of Belarus, not related to its presentation, dosage form, completeness and amount in secondary packaging, Center for Examinations and Tests in Health Service RUE shall introduce the corresponding changes into the register entry on registration of ex-works price limit for the medicinal product with retention of the latest registered ex-works price limit for the medicinal product.
9. Center for Examinations and Tests in Health Service RUE shall issue an extract from the register to the marketing authorization holder (its authorized person) upon introduction of changes into the register entry.
10. The data on registration of ex-works price limit for the medicinal product shall be subject to striking off the register if:
the medicinal product are stricken off the State Register of Medicinal Products of the Republic of Belarus;
the decision on registration of ex-works price limit for the medicinal product is revoked.
11. If the Ministry of Health accepting the decision on striking off the data on registration of ex-works price limit for the medicinal product, the corresponding entry shall be made in the register within three business days as of the date of such decision stating its reason and the date.
12. The register shall be published on the official site of Center for Examinations and Tests in Health Service RUE on the Internet and shall be updated daily.
The data contained in the register shall be open and publicly available.