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REVIEW OF LEGAL REGULATION OF PHARMACEUTICAL BUSINESS IN THE REPUBLIC OF BELARUS


_______________2018_________________
Good day, dear reader!


Pharmaceutical markets in various countries have their peculiarities in terms of legal regulation, and the Belarusian pharmaceutical market is not an exception. Many pharmaceutical guides would exploit one of the two usual extremities: either provide very generic and loose information, or tend to quote nearly all legal regulations.

Our guide aims at not just reporting the control

rules applicable to the Belarusian pharmaceutical market, but at helping you to assess risks all by your-

self and to form a competent and unbiased opinion on the opportunities of your business in Belarus. Our guide gives an account of all areas of pharmaceutical business – from registration and imports of pharmaceutical products to price formation – in an integrated and consistent manner. You can get a deeper in- sight into each of the topics by checking the links to applicable legal norms.

This guide will be of great value for companies which look upon Belarus as a prospective market for launching of production or for sales of their pharmaceutical products.

The specialists of the Ministry of Health of the Republic of Belarus rendered invaluable help in preparing and updating the review. We are sincerely grateful to the Ministry for assistance and expert support. I believe that the Doing Pharmaceutical Business in Belarus guide will provide answers to your questions and will be helpful in making your proper decisions.



Best regards,
Dmitry Arkhipenko,
Managing partner of REVERA


The information in this section has been furnished by Intellix-M com- pany. Please note that all data, tables and drawings in this section are not official statistical information and cannot be considered the sole source of information on the Belarusian market.
Dynamics of the Belarusian pharmaceutical market over 2014–2017 is as follows.
In 2017 the Belarusian pharmaceutical market saw a growth by 1.29% in natural units and by 10% in money terms. This market has always shown a positive dynamics in Belarusian roubles throughout 2014–2017, however demonstrating declines in terms of foreign currency. A rapid market growth in US dollars, as compared to the BYN growth, is due to the revaluation of the Belarusian rouble in 2017.

As regards pharmaceutical consumption patterns in Belarusian regions, the current situation is as follows:





Regional structure of Belarusian pharmaceutical market in 2017 (sales percentage (in wholesale prices) of the nationwide market volume in USD).

Consumption in USD and in packs per 100,000 people
Per capita pharmaceutical consumption (in BYN) is growing annually and has shown a double growth over the last five years, while the Belarusian rouble has also shown a doubling growth over the same period.

Overall pharmaceutical expenses in USD however decreased. Actually, Belarusians are not now consuming more pharmaceuticals – their expenses have increased only due to the growing per pack costs, which is because of the devaluation of the Belarusian rouble. These trends apply to both foreign and domestic pharmaceuticals.





Per capita consumption of pharmaceuticals in 2012–2017
Top 10 manufacturers in Belarusian pharmaceutical market in 2017
Considering all factors, we may envisage that the Belarusian pharmaceutical market will grow in 2018, both in natural units and in money terms. Growth in packs is expected to be between 2 to 4%, while growth in money terms may reach 8 to 14%.

Forecast for pharmaceutical market dynamics in 2018

A special permit (a license) is necessary for a range of pharmaceutical business activities in Belarus. A license is a document confirming its holder's (licensee's) compliance with the licensing requirements and terms – i.e. with the crucial requirements for the respective business activity.

Procedures for issuance and revocation of licenses, requirements to applicants and holders of licenses (licensees) have been established by the Regulation on Licensing of Particular Business Activities as approved by Decree of the President of the Republic of Belarus No. 450 dated 01.09.2010.

Any commercial activities performed without a license (where a license is required), or non-compliance with applicable license requirements and conditions will invoke administrative responsibility (p. 1 art. 12.7 of the Administrative Offences Code).

Where revenues from such illegal activities exceed 250 basic units (6,125 BYN, or ca. 3,000 USD) such activities will invoke criminal responsibility under art. 233 of the Criminal Code of the Republic of Belarus.
A license is requisite for the following pharmaceutical activities:
1. Works and services related to commercial manufacture of, and wholesale trade in pharmaceutical products, in particular:
commercial manufacture of, and wholesale trade in pharmaceutical products;

commercial manufacture of, and wholesale trade in gases used for medical purposes;

commercial manufacture of, and wholesale trade in radiopharmaceuticals;

commercial manufacture of, and wholesale trade in alcoholic pharmaceutical products;

commercial manufacture of, and wholesale trade in finished pharmaceutical products/substances in terms of pre-packing and packaging;

commercial manufacture of, and wholesale trade in pharmaceutical products in terms of processing, pre-packing and packaging of medicinal plant raw material and herbal teas.
2. Works and services related to sales, pharmacy production and dispensing of pharmaceutical products. In particular:
pharmacy production of pharmaceutical products;

dispensing of pharmaceutical products to health care organisations or their structural subdivisions;

wholesale trade in pharmaceutical products of domestic and/or foreign manufacture;

wholesale trade in pharmaceutical products to health care organisations;

retail trade in pharmaceutical products.
Licenses are granted by the Ministry of Public Health of the Republic of Belarus (MPH). The MPH is a licensing authority in this sphere and is in charge of decision-making, particularly, in terms of amendments, suspension, resumption, dissolution and revocation of licenses, issues duplicate copies of licenses and monitors compliance with key license requirements and conditions.

Licenses may be issued to Belarusian legal entities and individual entrepreneurs (IEs), as well as foreign entities having representative offices in Belarus.

A license provides a right for respective activities only to its holder (licensee), no assignment of such right to any third party is allowed. If a licensee is being reorganised, a specially established procedure applies.
The licensee is obliged to apply for the amendment of its license within one month, if any data specified in the license (for instance, licensee's name, location, etc.) have been altered, or if any provisions of applicable laws have been changed which necessitate such license amendments.

A copy of a license may be issued, if a license has been lost. The state duty for any amendments into a license and/or issuance of a duplicate copy of a license is 5 BUs (122.5 Belarusian roubles or ca. 60 US dollars).
1. Preparation stage.
This stage is the longest of all. During this stage, the applicant shall prove its compliance with license requirements and conditions. It will require:

recruiting personnel with requisite education level and qualifications;

finding premises conforming with statutory requirements (supported by an expert report of a local sanitary authority on such conformity);

acquiring title to, or purchasing on another lawful ground, the requisite equipment.

The current license requirements and conditions are described in the following subsection of this section.
2. Submission of documents to MPH.
In order to obtain a license, you shall submit the following to MPH:

application;

an extract from the trade register or a similar document (for foreign entities);

document confirming state duty payment (state duty amounts to 10 basic units – 245 Belarusian roubles or about 120 US dollars);

documents confirming compliance with license requirements.

License requirements differ subject to business activity. Accordingly, there are different supporting documents (for instance, concerning office premises, employees, equipment, etc.). Documents or data not prescribed by law cannot be required by any authority.
3. Valuation and examination of compliance with license requirements and conditions.
MPH prescribes such an examination or valuation at its own discretion (no prescription criteria established by the laws).

Procedures for valuations and examinations have been established by the Guidelines approved by Resolution No. 145 of the Ministry of Public Health of the Republic of Belarus dated 16 November, 2010.

Valuation and examination are required in order to validate information integrity in the documents submitted for license acquisition and to check applicant's commitment to its business activities. Based on the results of a valuation or an examination, a conclusion will be prepared indicating compliance (or non-compliance) with license requirements and conditions.
4. Decision on license issuance or refusal.
A decision is normally taken within 15 business days following submission of application. This time frame may be extended by another 10 days, where compliance valuation or examination is performed. The decision will be communicated to the applicant within 3 business days. In case of a positive decision, a license will be granted to the applicant.

MPH decision may be appealed in a court of law within one month following receipt of notification of such decision.
2.3. General license requirements
Requirements to applicants for licenses differ subject to components of pharmaceutical activity to be performed by applicant.
Activity - works and services related to trade in, pharmacy production of, and dispensing of pharmaceutical products
License requirements:

Head/manager of a pharmacy storehouse or a pharmacy (or a person in charge of licensed activities in a standalone division, and/or head of local health agency) must have:

-his/her employment in such entity must be primary employment
-university degree in pharmaceutics
-first or highest qualification category (not required for working in radioactive contamination zones and pharmacies of categories 3 to 5);
-certificate of advanced training or professional retraining;
-such person must be made responsible (by a written order) for the performance of the licensed activities.

All requirements to such head/manager also apply to an IE applying for a license.

At least 2 employees (apart from the manager) must have:

-higher or vocational secondary pharmaceutical education;
-a qualification category (apart from employees of pharmacies of categories 3 to 5 and those working in radioactive contamination zones)
-certificate of advanced training or professional retraining (in respective area of expertise).

Other employees involved in the licensed activity must have:

-higher or vocational secondary pharmaceutical education;
-certificate of advanced training or professional retraining (in a respective area of expertise).
Activity - works and services related to commercial production of, and wholesale trade in, pharmaceutical products
License requirements:

Premises, equipment and transport facilities requisite for the licensed activity must be lawfully owned.

The full-time specialist must have:

-university degree in chemical technology, chemical pharmaceutics, biotechnologies, pharmaceutics or medicine;
-period of service in PP manufacturing entities of at least 2 years;
-such person must be made responsible (by a written order) for the quality of, and wholesale trade in, manufactured pharmaceutical products.
Additional requirements for license holder are:
-licensed activities shall be carried out in locations/premises as specified by the license;

-compliance with requirements and conditions as prescribed by regulatory acts, including compulsory requirements of technical regulatory standards pertaining to pharmaceutical products circulation. The latter include Good Manufacturing Practice [1] and Good Pharmacy Practice [2] , special sanitary rules, and requirements prescribed by EAEU acts [3] .

[1] The Good Manufacturing Practice has been established by the Technical Code of Practice 030-2017 (33050) "Good Manufacturing Practice" ratified by Resolution No. 64 of the Ministry of Public Health of the Republic of Belarus dated 19.06.2017.

[2] The Good Pharmacy Practice has been ratified by Resolution No. 120 of the Ministry of Public Health of the Republic of Belarus dated 27.12.2006.

[3] http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx
Applicant must comply with the applicable technical acts already at the stage of application filing. The package of documents to be submitted to the licensing authority shall contain a report by a sanitary control authority confirming proper compliance of applicant's premises to the sanitary rules and their fitness for applicant's purposes.
2.4. Special licensing requirements to pharmacies

Various license requirements are applicable to various pharmacy categories. There are 5 pharmacy categories, classified subject to their activities and services rendered, room spaces occupied and traded pharmaceutical products and narcotic/psychotropic substances.
Pharmacy categories and pharmacy requirements have been defined by the Good Pharmacy Practice ratified by Resolution No. 120 of the Ministry of Public Health of the Republic of Belarus dated 27.12.2006.
Category 1 (apart from hospital pharmacies)
Activities and services rendered:

1. Pharmacy manufacturing of PPs, narcotic and psychotropic substances.
2. Prepackaging.
3. Quality inspection of PPs manufactured.
4. Retail sales of PPs to general public and organisations for medical use.
5. Pharmacy production of narcotic and psychotropic substances on prescription, their retail sales to health agencies and general public (under an individual license).

Required premises:

Floor space must be at least 100 sq.m. (in case of a hospital pharmacy – according to the work scope), and must include:

1. inlet premise or area;
2. at least 2 storage rooms;
3. salesroom (for retail sales of PPs);
4. administrative and personnel facilities (personnel room and cloak room (may be combined), administration office, lavatory);
5. production areas: water treating and sterilization rooms (may be combined), utensil treatment room, packing and accessory materials treatment room; PPs production room, aseptic room with a lock chamber (where PPs are produced in aseptic/sterile conditions);
6. PPs quality control room/area.
Hospital pharmacy category 1
Activities and services rendered:

1. Pharmacy manufacturing of PPs.
2. Dispensing PPs to health agencies or their structural subdivisions.
3. Pharmacy manufacturing and dispensing of narcotic and psychotropic substances to health agencies or their structural subdivisions (under an individual license).

Required premises:

Floor space must be at least 100 sq.m. (in case of a hospital pharmacy – according to the work scope), and must include:

1. inlet premise or area;
2. at least 2 storage rooms;
3. salesroom (for retail sales of PPs);
4. administrative and personnel facilities (personnel room and cloak room (may be combined), administration office, lavatory);
5. production areas: water treating and sterilization rooms (may be combined), utensil treatment room, packing and accessory materials treatment room; PPs production room, aseptic room with a lock chamber (where PPs are produced in aseptic/sterile conditions);
6. PPs quality control room/area.
Category 2 (except for hospital pharmacies)
Activities and services rendered:

Retail sales of:

1. PPs – to general public and organisations for medical use.
2. Narcotic/psychotropic drugs – to health agencies and general public (under an individual license).
Необходимый комплекс помещений

Required premises:

Floor space must be at least 60 sq.m. (in case of a hospital pharmacy – according to the work scope, but at least 60 sq.m.), and must include:

1. salesroom (for retail sales of PPs);
2. storage room (if PPs are sold at retail to health agencies – at least 2 storage rooms);
3. administrative and personnel facilities: personnel room and cloak room (may be combined), lavatory, administration office;
4. products inlet areas.
Hospital pharmacy category 2
Activities and services rendered:

1. Dispensing PPs and narcotic / psychotropic drugs to health agencies or their structural subdivisions.

Required premises:


Floor space must be at least 60 sq.m. (in case of a hospital pharmacy – according to the work scope, but at least 60 sq.m.), and must include:

1. salesroom (for retail sales of PPs);
2. storage room (if PPs are sold at retail to health agencies – at least 2 storage rooms);
3. administrative and personnel facilities: personnel room and cloak room (may be combined), lavatory, administration office;
4. products inlet areas
Category 3*
*Are created in rural areas and "agrotowns", where the founding entity/IE has a category 1 or category 2 pharmacy.

Activities and services rendered:

1. Retail sales of PPs.
2. Retail sales of psychotropic drugs (under an individual license).

Required premises:


Floor space must be at least 20 sq.m. and include:

1. salesroom;
2. storage room;
3. products inlet area;
4. hand-washing basin is obligatory.
Category 4**
**Are created within health agencies, where such agency or IE has a category 1 or category 2 pharmacy.

Activities and services rendered:

1. Retail sales of PPs.
2. Retail sales of psychotropic drugs (under an individual license).

Required premises:


Floor space must be at least 15 sq.m. and include 1 or more premises (rooms) including the following rooms which must be separate:

1. inlet areas;
2. storage areas;
3. public service areas.
Категория 5***
***Are created in local hubs – stores, markets, passenger buildings, etc., where the founding entity/IE has a category 1 or category 2 pharmacy.

Activities and services rendered:

1. Retail sales of PPs.

Required premises:


Floor space must be at least 15 sq.m., the pharmacy must be located in premises isolated from premises of other use, and must include:

1. inlet area;
2. storage area;
3. public service area.
Apart from the requirements to premise structure, there are also a number of other requirements binding upon pharmacies (for instance, regarding porch structure, interior fit-out, equipment, etc.).
Requirements to territory, water supply, water disposal, microclimate, room ventilation and lighting, maintenance and operation of premises, equipment, furniture and fittings, personal hygiene of pharmacy employees, etc. have been established by the Sanitary Regulations "Sanitary requirements for pharmacies" approved by Resolution No. 154 of the Ministry of Public Health of the Republic of Belarus dated 01.10.2012.

All pharmacies involved in retail trading in pharmaceutical products, regardless of form of ownership, must at all times offer a set of pharmaceutical products prescribed by MPH. The list of such products was last amended on 28 August, 2017 by MPH Resolution No. 84 [1] .

[1] The current list is available at: http://pravo.by/upload/docs/op/W21732390_1505336400.pdf.
2.5. Special licensing requirements for wholesale trade in medicines
In Belarus, wholesale trading in pharmaceutical products of both domestic and foreign manufacture is performed from pharmacy storehouses.

A pharmacy storehouse is a suite of designated premises and equipment units designed for acceptance, registration, sample taking, storage, sales and safeguarding of pharmaceutical products.
Rules for wholesale trade in pharmaceutical products have been established by Good wholesale trade practice, approved by Resolution No. 6 of the Ministry of Public Health of the Republic of Belarus dated 15.01.2007 [1] .

[1] The EAEU level has also the Good Distributorship Practice ratified by Resolution of the EEC Council No. 80 dated 03.11.2016
Floor area of a pharmacy storehouse (exclusive of administrative and personnel premises) must be at least 100 sq.m. and must include (in succession):
1. a premise, area or ramp for handling operations;
2. a premise for pharmaceutical products delivery;
3. a premise for pharmaceutical products storage;
4. a premise or area for pharmaceutical products offloading;
5. administrative and personnel premises: office premise; cloak room, dining room (may be combined); lavatory;
Where pharmaceutical substances are packaged within the pharmacy storehouse, the following premises must be provided:
1. packaging room – with a floor area of at least 20 sq.m;
2. distillation and sterilization room – with a floor area of at least 10 sq.m;
3. washery – with a floor area of at least 12 sq.m.
A pharmacy storehouse must be located in non-residential premises of permanent buildings/structures, and its storage rooms must be isolated from premises of other use.

The handling premise/area/ramp must have all requisite facilities for the clean-up of shipping containers of any impurities.

There are also requirements to storehouse interior fit-out, equipment, etc.
2.6. Validity of license
A license is valid from the date MPH rendered a decision on its issuance, and is not limited by any time frame. If a licensee infringes any terms of its license, the MPH as the licensing authority may suspend or terminate such license.

In case of any violation revealed, MPH will first issue an order prescribing that such licensee should cure the violation and should report such corrective measures together with relevant supporting documents.
If violations are not cured within 6 months, MPH will suspend the license for a period of up to 6 months.

If violations are not cured before the suspension period expires, MPH will terminate such license.
MPH will terminate the license forthwith, where:
1) a recurrent violation of licensing laws has been revealed within 12 months following removal of a similar violation;
2) a flagrant violation of licensing laws has been revealed. The following are "flagrant violations" of licensing laws:
-sales of any PPs, prohibited for sales (for instance, unregistered, or past their sell-by date, forged, etc. [1] );
-violation of PPs storage conditions, resulting in non-conformity of their quality to legislative requirements;
-violation of laws in terms of withdrawal and destruction of PPs past their sell-by date, off-quality or forged PPs, destruction or returns outwards of PPs, rejected by testing laboratory;
-violation of license requirements and conditions imposed on license applicant (apart from commercial manufacture of PPs);
-operation in places/premises not specified by the license;
-persistent (twice or more within 12 consecutive months) violation of legislative requirements in terms of:

а) exceeding the approved volume of pharmaceutical products (dosages, packs) sold without prescription;
b) failure of such pharmacy to offer PPs from the list of mandatory PPs of Belarusian (Russian) manufacture.

[1] Art. 19, Law of the Republic of Belarus No. 161-З "On pharmaceutical products" dated 20.07.2006
The state registration involves inspection of conformance of a pharmaceutical product to the safety, efficiency and quality requirements as established by existing national practices or EAEU practices, as specified in the table below.
It is state registration that will subsume a pharmaceutical product to one of the following categories:
1
to be sold on doctor's prescription, without doctor's prescription, or only for medical treatment of patients in day-and-night clinics;
2
narcotic drugs or psychotropic substances;
3
"a list" pharmaceutical products with toxic properties constituting possible threat for human health and requiring special storage conditions.
Procedures and terms of state registration of pharmaceutical products/substances have been established by the Regulation approved by Resolution No. 254 of the Council of Ministers of the Republic of Belarus dated 01.04.2015 (hereinafter – Regulation No. 254)
In order to be produced commercially, sold, and used in medicine, any pharmaceutical products must be included in the State Register of pharmaceutical products of the Republic of Belarus. This applies both to domestic and foreign pharmaceutical products to be sold and used in Belarus.
However, there is a number of exceptions from this rule. The following pharmaceutical products are not subject to state registration:

1. produced in pharmacies;
2. designed for demonstration as exhibition samples;
3. designed for preclinical studies and clinical trials;
4. imported in the territory of the Republic of Belarus by natural persons for personal use;
5. designed for commercial manufacture for export only.
Moreover, a separate registration procedure for a pharmaceutical substance is not required, if registration dossiers for pharmaceutical products containing such substances comprise manufacturer's certificates of such pharmaceutical substances conforming with the requirements to registration dossier documents.
Medicinal plant raw material is subject to state registration as pharmaceutical product provided it has undergone a stage of production process which has given it a specific pharmaceutical form.
3.2. State registration procedure
State registration procedure comprises several stages.
Stage 1
Submitting documents to the Expert Examinations Center
1. Concluding an agreement with the Expert Examinations Center.
This agreement becomes effective immediately upon the payment for preliminary works. The cost of works is subject to drug group, dosage, output volumes and other parameters of the registered medicine. More information on costs of the works is available on the Expert Examinations Center's website [1] .


[1] http://www.rceth.by/ru/Service/PricesList.
1. Submitting documents required for state registration [1] .
[1] cl. 10.13 to 10.18 of the Catalogue of administrative procedures.

The list of required documents differs for pharmaceutical substances and medicines, as well as for Belarusian and foreign manufacturers. Requirements to these documents are established by Decision No. 52 of the Ministry of Health of the Republic of Belarus dated 08.05.2009 (hereinafter – Decision No. 52).
For instance, a Belarusian manufacturer applying for registration of a medicine shall submit:
an application form as officially established [1];
[1] The form has been approved by Appendix 1 to Decision No. 52.
a draft instruction for drug use and/or draft package leaflet, and graphic package design in Belarusian or Russian;
a draft of manufacturer's pharmacopoeia monograph [1];
[1] A draft pharmaceutical monograph shall be prepared in accordance with the technical code of practice 123-2008 (02040) "Pharmaceutical monographs. Drafting and approval procedures" as approved by Decision No. 37 of the Ministry of Health of the Republic of Belarus dated 18.02.2008 (as amended on 07.09.2015). In future, a unified EAEU Pharmacopoeia will be developed (see Section 9 of the present review).
manufacturer's documents containing:
Содержащие:

a) a description of a manufacturing process (including volume of industrial output). Where two or more manufacturers are involved, such a document shall be submitted by each of them;

b) proof of quality of a drug series, stability tests results (plan, report, tables demonstrating examination findings of at least two series of the drug);

c) a report on bioavailability/bioequivalence, for generic medicines (if applicable) [1] ;

d) a report on pre-clinical studies of the medicine (except generic medicines; not applicable in case of medicines made of plant raw material) [2] ;

e) a report on clinical studies of the medicine subject to the Good Clinical Practice (where a bioequivalence report is submitted) [3] ;


[1] A manufacturer should meet the requirements of the National Pharmacopoeia of the Republic of Belarus (section 5.8, vol. 1) or the requirements of the EAEU Rules of bioequivalence studies (see Section 9 hereof).


[2] Must comply with the requirements of the technical code of practice 125-2008 (02040) "Good Laboratory Practice" as approved by Decision No. 56 of the Ministry of Health of the Republic of Belarus dated 28.03.2008 (hereinafter – the Good Laboratory Practice of the Republic of Belarus), or of the EAEU Good Laboratory Practice (see Section 9 hereof).


[3] Shall be developed in accordance with the technical code of practice 184-2009 (02040) "Good Clinical Practice" as approved by Decision No. 50 of the Ministry of Health of the Republic of Belarus dated 07.05.2009 (hereinafter – the Good Clinical Practice of the Republic of Belarus), or of the EAEU Good Clinical Practice (see Section 9 hereof).
case study about medicine use – scientific articles, monographs, publications, clinical protocols, methodological guides.
This list is different for medicines produced by a foreign manufacturer, which includes:
an application form as officially established;
a notarised copy of:
a) confirmation of state registration of such medicine in the manufacturer's country (registration certificate, free sale certificate, medicine's certificate). Where two or more manufacturers are involved, information shall be provided about each of them;

b) an evidence that a manufacturer is eligible to produce the medicine;

c) a manufacturer's license and a document confirming the medicine is manufactured in compliance with the Good Manufacturing Practice [1] ;


[1] Pursuant to the technical specifications of the Good Manufacturing Practice of the Republic of Belarus or the EAEU Good Manufacturing Practice (see Section 9 hereof).
a draft instruction for drug use and/or draft package leaflet, and graphic package design in Belarusian or Russian;
manufacturer's documents containing:
a) drug formulation, with reference to quality control regulations (e.g. pharmaceutical monographs);

b) a description of a manufacturing process (including volume of industrial output). Where two or more manufacturers are involved, such a document shall be submitted by each of them;

c) quality indicators and quality control techniques used with regard to the medicine, the pharmaceutical substance and the additive agents;

d) proof of quality of a drug series, stability tests results (plan, report, tables demonstrating examination findings of at least two series of the drug ;

e) a description of methods of obtaining a pharmaceutical substance, a brief scheme of its manufacturing;
a regulatory document containing quality indicators and quality control techniques used with regard to the medicines, the pharmaceutical substance and the additive agents;
authenticated by the applicant copies of reports:
a) on the validation of quality control techniques;

b) on bioavailability/bioequivalence studies of generic medicines (if applicable) [1] ;

c) on pre-clinical studies (except generic medicines) [2] ;

d) on clinical studies [3] ;


[1] In accordance with the requirements of the World Health Organisation on the registration of multi-sourced (generic) pharmaceutical products (cl. 1.2.12 of Resolution No. 52).


[2] In accordance with the Good Laboratory Practice of the Republic of Belarus or the EAEU (ref. section 9 hereof).


[3] In accordance with the Good Clinical Practice of the Republic of Belarus or the EAEU (ref. section 9 hereof).
applicant's declaration describing any environmental risks of the proposed medicine which contains genetically modified components;
case study about medicine use – scientific articles, monographs, publications, clinical protocols, methodological guides.
Stage 2
Technical preliminary works
Technical preliminaries are carried out by the national unitary enterprise "Centre for Expert Examinations and Tests in Public Health Service" (hereinafter – the Expert Examinations Centre", http://www.rceth.by/).
The procedures of organisational management have been established by the Rules approved by Resolution No. 55 of the Ministry of Public Health of the Republic of Belarus dated 23.04.2015 (hereinafter – Rules No. 55).
This stage involves:
1. Preliminary examination of documents required for state registration.
The Expert Examinations Center verifies whether the submitted documents are complete and correct, confirms usability of the declared trade name of the pharmaceutical product, and determines further required technical works. Time frame – 15 calendar days.
2. Inspecting the commercial manufacture process for compliance with the Good Manufacturing Practice. [1]

[1] Belarusian or EAEU's Good Manufacturing Practice shall be used.
The procedures for such inspection is established by the Rules approved by Resolution No. 72 of the Ministry of Health of the Republic of Belarus dated 14.05.2015 (hereinafter – Rules No. 72) [1] .

[1] At the EAEU level, there are also rules for pharmaceutical inspections approved by Decision No. 83 of the EEC Council dated 03.11.2016, applicable for inspections of compliance with the EAEU's Good Manufacturing Practice.
Inspection is only carried out where the production process (or its part) involves a production site not inspected during last 5 years. Inspection coveres all involved production sites and includes:
1
visiting the production site(s);
2
notifying the manufacturer of the initiated inspection, its goals and procedures;
3
presenting preliminary inspection findings to manufacturer's representatives;
4
examination of the production site dossier, documents in the registration dossier and other documents pertaining to such inspection;
A production site dossier is a document formed by the manufacturer and containing information on the activities at the production site and at any adjacent production sites (including those in neighbouring buildings), on the stages of commercial manufacture and/or quality control of pharmaceutical products at each stage of commercial manufacture, and on the quality policies applied by the manufacturer [1] .

[1] cl. 2 of Manual No. 72.
5
inspecting storage and manufacturing premises/areas, engineering systems, equipment used at the production site, monitoring the drug production process and quality control procedures, monitoring employees' workplace activities, questioning persons in charge, checking documentation and records, according to the inspection schedule;
6
delivering a report with inspection findings
The report will be delivered to the applicant for examination. Where any discrepancies of the production process with the Good Manufacturing Practice are found, the manufacturer shall correct such discrepancies in one month and report such correction to the inspectorate. The inspection findings will further be considered for the purpose of final Expert Center.
The inspectors may make use of technical facilities, including voice recording, video recording and camera recording devices – upon manufacturer's written consent.

In practice, where a foreign manufacturer has a national certificate of Good Manufacturing Practice issued by one of the EAEU states, such foreign manufacturer will be exempt from inspections in the Republic of Belarus [1] . This, however, applies only to pharmaceutical products produced in the EAEU.

[1] cl. 7 art. 7 of the Agreement on unified principles and rules of pharmaceuticals trade in the Eurasian Economic Union.
Inspection time frame is up to 90 calendar days.
1. Approbation of the drug quality control technique, quality surveys using such technique, and drug quality analysis in the course of clinical trials run by public health care organisations.
Approbation of the drug quality control technique and drug quality surveys using such technique will be carried out based on the indicators specified by manufacturer's pharmaceutical monographs or a regulatory document containing such indicators and techniques. However, only pharmaceutical products submitted for registration for the first time are subject to approbation.
If samples to be used in approbation and/or quality control are high-priced in all indicators (i.e. their cost is above 1,000 US dollars at the exchange rate of the National Bank of the Republic of Belarus), then approbation and quality control will only be carried out in those indicators which are to be used for the purpose of authentication (identification), quantitative active ingredient content and attendant impurities content.
Under the general rule, approbation of techniques and quality control shall be carried out at premises where respective specialists are located. However, in exceptional cases (where a manufacturer is not capable of delivering high-priced samples, or the public health organisation does not have required technical facilities), the approbation and quality control procedures are carried out by the applicant at its location. Therewith, specialists of public health care authorities of the Republic of Belarus will validate such procedures.
Approbation and quality control procedures are not carried out in respect of narcotic and psychotropic substances, radiopharmaceuticals and medicines intended for patients with rare pathologies.
4. Specialised document examination for drug compliance with safety, efficiency and quality requirements, subject to their pharmaceutical, clinical and pharmacological features.
For the purpose of this examination, the Expert Center appoints experts, each of which prepares a separate expert report. Where there are any contradictions in the experts' reports, this will be considered for the purpose of the final opinion. The experts' reports will be delivered to the applicant for examination, and the applicant will have 40 days for correcting all specified remarks.
The time frame of the specialised document examination is 60 calendar days.
5. Trials to study the bioavailability (bioequivalence) of generic pharmaceutical products (except for medicines made of plant raw material).
6. Clinical trials of the pharmaceutical product.
If trials of bioavailability or clinical trials of a foreign manufacturer's pharmaceutical product were carried out earlier and such applicant has relevant documents valid as of the date of filing, the Expert Center may exempt such applicant from such repeated procedures.
7. Other surveys/trials (if necessary).
The total duration of such surveys/trials shall not exceed 180 calendar days (i.e. the duration of the contract for technical preliminaries).
In the event of positive findings, the Center issues its final report on the conformity of the mediicine/substance to the existing requirements in terms of safety, efficiency and quality. Such final report will specify the findings of each of the stages of works. In exceptional cases (where there are only minor discrepancies), the Center issues its expert report, but will concurrently oblige the applicant to correct any discrepancies prior to the registration procedures in the Ministry of Health.
The period of validity of such expert report is 6 months as of its date.
Stage 3
Submitting registration dossier to MPH
After the Expert Center has delivered its final report, the issue of drug registration will be considered by the Committee on medicinal products and pharmaceutical substances of the Ministry of Health (hereinafter – the Committee) [1] . The Committee makes decisions on the state registration of medicines and pharmaceutical substances and on amendments made in the registration dossiers.

The Expert Center provides the registration dossier to the Ministry of Health, to be examined by the Committee. A registration dossier is a package of documents submitted for state registration of a medicine or a pharmaceutical substance. Such dossier also comprises the Expert Center's final report, the approbation and inspection reports, and the expert opinions relating to the specialised document examination.

[1] Formation and functions of the Committee have been regulated by Resolution No. 56 of the Ministry of Public Health dated 23.04.2015.
Pharmaceutical substances used in drug production may be registered separately from the respective medicinal products. If a pharmaceutical substance is not registered, an applicant, during drug registration procedures, shall also furnish a manufacturer's document confirming proper quality of one series of such pharmaceutical substance and the findings of stability tests of at least two series of such pharmaceutical substance (plan, report, tables demonstrating research findings).
Duration of review of such documents by the Committee is at least 15 days and may last up to 1 month (where MPH needs to direct inquiries to other agencies). Any Committee's decision will be communicated to the applicant within 5 business days.
Stage 4
Payment of state duty and state registration
In the event of Committee's positive decision, the applicant has to pay the state registration duty amounting to 10 basic units (245 Belarusian roubles, or ca. 124 US dollars).
Within 5 days following payment confirmation, the Expert Examinations Center will enter respective data into the State Register of Pharmaceutical Products of the Republic of Belarus and will issue a registration certificate to the applicant. The procedure for issuing this registration certificate have been regulated by Regulation No. 254.
Where a pharmaceutical product has been registered:

- simultaneously in several pharmaceutical forms, – then one registration certificate shall be issued for each of the pharmaceutical forms;

- produced by pharmaceutical manufacturers (their standalone subdivisions) located in different countries, – then one registration certificate shall be issued for each of the pharmaceutical products produced in a different country;

- simultaneously in one pharmaceutical form but with different dosages, – then a single registration certificate shall be issued, provided that any further state registration of a new dosage must produce a new registration certificate.
Pharmaceutical products registered in the Republic of Belarus for the first time will obtain registration certificates with a validity period of 5 years. Upon expiry of this period, holders must undergo a state registration confirmation procedure, which is similar to the procedure of state registration. Upon confirmation of state registration, an unlimited registration certificate will be issued.

Registered pharmaceutical substances (including those registered for the first time) obtaines an unlimited registration certificate.
Where any amendments are introduced into the documents supporting any registered pharmaceutical product, a prescribed administrative procedure must be carried out [1] . In such a case, the Expert Center will verify the documents provided (subject to introduced amendments) and will carry out other technical formalities (including inspection of production facilities), subject to introduced amendments.

[1] Cl. 10.18 of the List of administrative procedures
3.3. Marking of pharmaceutical products

In order to register a pharmaceutical product, an applicant, along with relevant documents, must submit a packing design with a marking in Russian or Belarusian language and a graphic design model.

Thus, even before the state registration, an applicant must have a packing model for its pharmaceutical product, including all information to be placed on such packing.
Requirements to the marking of pharmaceutical products have been specified by Decision of EEC Council No. 76 dated 03.11.2016 and Resolution of the Ministry of Public Health of the Republic of Belarus No. 52 dated 08.05.2009.
Requirements to the marking of pharmaceutical products are tentatively divided into:
-general requirements

-requirements to marking content

-requirements to marking application technique
The general requirements include instructions on the information which must be included in the primary and the secondary packing.
Requirements to marking content provide instructions on the methods of information display in inner and secondary packs and types of warning notices to be present on such packs. Thus, for instance, names of pharmaceutical products shall be indicated in the nominative case, and addresses may be indicated either compactly (country, or country and town) or in full; additionally, telephone/fax numbers and/or e-mails may be indicated.
Способы нанесения маркировки устанавливают положения о том, какая цветовая гамма упаковки должна быть использована, рекомендации к материалу упаковки и размеру символам, наносимых на упаковку.
Regulation of pharmaceutical pricing in the Republic of Belarus is done by establishing maximum ex-factory prices of certain medicines and maximum wholesale and retail markups. The retail prices formed with regard to these limits are also controlled by the authorities.
Normally, pharmaceutical manufacturers' prices are free-of-control. Free-of-control prices are prices that are formed under the influence of supply and demand in conditions of free competition. [1]

Controlled prices are established for an exhaustive list of medicines of Belarusian manufacturers [2] .
[1] Law of the Republic of Belarus No 255-З of May 10, 1999 "On Price Formation "

[2] Edict of the President of the Republic of Belarus No. 72 of February 25, 2011 concerning issues of price/tariff regulation in the Republic of Belarus
At present, this list includes 35 medicines with the following international non-proprietary names:
atropine, metoclopramide, lactulose, loperamide, calcium gluconate, folic acid, hydroxyethylated starch, sodium carbonate, amiodarone, clonidine, hydrochlorothiazide, indapamide, propranolol, atenolol, metoprolol, simvastatin, 70% ethanol, cefoperazone, ceftazidime, clindamycin, amikacin, streptomycin, moxifloxacin, imatinib, tamoxifen, morphine, trimeperidin, phentanyl, carbamazepine, phenobarbital, haloperidol, pyrantel, aminophylline, loratadine and pilocarpine [1] .

[1] Decision of the Council of Ministers of the Republic of Belarus No. 56 of January 19, 2012 "On the list of medicines of Belarusian manufacturers subject to price regulation by the Ministry of Healthcare
The list of companies subject to the restrictions of maximum ex-factory prices includes:
PharmTech CJSC, AcademPharm UE, Nesvizh Medical Supplies Factory OJSC, Borysov Medical Supplies Factory OJSC, BelAseptica CJSC, Bobruisk Biotechnology Factory OJSC, Lek- Pharm JLLC, BelMedPreparaty UE, PharmLand LLC, PharmTechnologia LLC and Ferein LLC [1].

[1] Decision of the Ministry of Healthcare of the Republic of Belarus No. 137 of September 7, 2012 "On maximum ex- factory prices of medicines of Belarusian manufacturers "
Prices of medicines of foreign manufacturers in the Republic of Belarus are not controlled. However, a maximum ex-factory price (so-called "declared price") shall be indicated during the registration of any (including foreign) medicines in Belarus. This price cannot be exceeded in further contracts for the supply of this medicine to the Republic of Belarus. Otherwise, the validity of the registration certificate may be suspended [1] and import of the medicine to the Republic of Belarus prohibited. If violations are not eliminated, registration can be terminated.

[1] Para. 4, part 16, art. 8 of the Law of the Republic of Belarus No. 161-З of July 20, 2006 "On Medicines."
The maximum ex-factory price declared should be comparable to ex-factory prices existing in:

-the country of a medicine's manufacturer (for foreign applicants);
-the EAEU Member States;
-other countries bordering the Republic of Belarus (Ukraine, Poland, Lithuania, Latvia).
The legislation does not provide any criteria for the comparability of medicine prices. In each particular case this issue is to be resolved by the Ministry of Healthcare of the Republic of Belarus.

During medicine registration, an applicant submits all documents necessary to substantiate the ex-factory price declared. After registration, this maximum price is indicated in the State Register of Medicines of the Republic of Belarus and in the registration certificate issued to the applicant.
Thus, at the time of registration of a foreign medicine the registration authority controls the compliance of the price of the medicine with the price in the reference countries. Thereafter, the observance of the declared maximum ex-factory price will be controlled in every supply of the medicine to Belarus.
4.2. Maximum wholesale and retail markups for medicines of Belarusian manufacturers
Maximum wholesale and retail markups have been established for medicines both of Belarusian and foreign manufacture. The algorithm for forming prices for medicines of Belarusian production taking into account maximum retail markups (commercial margins) looks as follows.
Wholesale prices for medicines of Belarusian manufacture are formed according to the formula:
Wholesale price = ex-factory price of the Belarusian manufacturer + wholesale markup
Ex-factory prices of Belarusian manufacturers are free-of-control, except for medicines of some Belarusian manufacturers mentioned above.

A wholesaler, after buying medicines from a manufacturer, may sell them at a lower price than the manufacturer's ex-factory price (for example during sales promotions).
As for the rate of the wholesale markup:
- its maximum rate depends on the ex-factory price of the medicine expressed in base figures and is defined as a percentage of the ex-factory price;

- such maximum wholesale markup shall include markups of all participants in the medicine supply chain [1] .

[1] Edict of the President of the Republic of Belarus No. 366 of August 11, 2005 "On formation of prices for medicines, medical products and devices."
* As of March 28, 2018, one basic unit is equal to BYN 24.5 or ca. EUR 10
Transportation costs from the manufacturer increase the ex-factory price. Consequently, it increases the possible markup and wholesale price, no matter who transports the goods under a contract, the manufacturer or the wholesale buyer.

The legislation expressly provides for the possibility of manufacturers' granting monetary and commodity discounts. However, if a manufacturer grants a monetary discount, the discount shall not affect the eventual markup and the wholesale price: they are calculated without considering the discount. Still, such a discount (i.e., actual profit) may be used only to purchase Belarusian medicines, to develop a pharmacy chain in rural areas and to compensate losses from production of medicines at pharmacies.
Provision of a commodity discount by a manufacturer, i.e., additional supply of free goods when a wholesale buyer fulfills any special contract conditions (e.g., reaching a purchase volume) will also not impact the eventual wholesale markup. A wholesale price for such goods will be formed based on the medicine price as specified by the contract (without considering the commodity discount).

Retail prices shall be calculated according to the following formula:

Retail price = wholesale price + commercial margin
The amount of a retail markup is also calculated as a percentage of the ex-factory price of the Belarusian manufacturer. The table above shows that the maximum rates of commercial margins are different from wholesale markups. Retail traders may also sell medicines at prices lower than wholesale prices and manufacturer's ex-factory prices.
4.3. Maximum wholesale/retail markups for medicines of foreign manufacturers
Wholesale prices for foreign medicines shall be calculated according to this formula:
Wholesale price = estimated ex-factory price + wholesale markup
In this context, the estimated ex-factory price shall be defined as follows:
Estimated ex-factory price = contract price + customs charges + import VAT + transport costs
A "contract price" means the price stated in the contract with a foreign manufacturer/supplier. The contract price shall not exceed the price declared during the registration of the medicin in Belarus.
Notably, because of changes in exchange rates, a seller can adjust the contract price to calculate the wholesale price every month, if:
- medicines have been placed under the "release for domestic consumption" customs procedure, and

- a wholesale buyer has accounts payable for the payment for such medicines to a foreign entity.
Just as in the case of Belarusian medicines, monetary discounts of foreign manufacturers/suppliers are not taken into account when calculating wholesale prices. Nonetheless, buyers may benefit from such discounts without restriction.

Retail prices for foreign medicines are formed in the same way as for Belarusian medicines:
Retail price = wholesale price + commercial margin
The commercial margin is calculated on the basis of the estimated ex-factory price, using the same percentage rates as with Belarusian medicines (given in the above table).

Just as Belarusian medicines, foreign drugs may be sold at a price lower than the estimated ex-factory price.
From August 25, 2018 manufacturers has to register maximum ex-factory prices for the [ВА1] following medicines for treatment oncologic and cardiovascular diseases [1]:

[1] The Decree of the President of the Republic of Belarus from August 22, 2018 No. 345 "On Registration of Prices for Medicinal Products".
The price of the listed medicines has to be registered until January 1, 2019. From the beginning of 2019 to December 31, 2020 the circulation of medicines with unregistered prices is prohibited in Belarus. The procedure of price registration has not been defined yet.
By November 25, 2018, the Council of Ministers of the Republic of Belarus will:
- define the procedure for registering the maximum ex-factory prices of manufacturers for medicines;
- create a state register of maximum ex-factory prices of manufacturers for medicines and determine the procedure for its maintenance.
The Ministry of Antimonopoly Regulation and Trade of Belarus, in coordination with the Ministry of Health, will determine the methodology for calculating maximum ex-factory prices.
Until July 1, 2020, the decision whether registration of manufacturer's maximum ex-factory prices for all medicines is needed will be made.
The Ministry of Healthcare, on the one hand, and all entities/individuals involved in pharmaceutical activities (retail/wholesale trading in medicines) in the Republic of Belarus, on the other hand, each year sign a memorandum on medicine price control.

The latest memorandum was signed on February 15, 2018.
According to its terms, the market participants shall:
- not raise selling prices higher than the recommended maximum retail prices. Maximum retail prices are to be defined by the Ministry of Health- care and published on the BelPharmacia website [1] ;

[1] https://pharma.by/news/1458.html

- control price increases for medicines through the use of optimal retail markups;

- increase as much as possible purchases of medicines of domestic manufacture by pharmacies of all forms of ownership;

- wholesale medicines purchased with monetary discounts at minimal wholesale markups;

- strive for a maximum reduction in purchases of foreign analogues of domestic medicines during procurement of medicines and elaboration of pharmacy assortment policies;

- notify the Belarusian Ministry of Healthcare of any sharp increases in contract or ex-factory prices.

[1] https://pharma.by/news/1458.html
For its part, the Belarusian Ministry of Healthcare undertook to:
- compile and publish (on the BelPharmacia website) the nomenclature of medicines specifying their maximum retail prices;

- prepare a comparative analysis of retail prices in EAEU Member States and other states bordering the Republic of Belarus (Russia, Ukraine, Kazakhstan, etc.) with the Belarusian retail prices of critical medicines included in the national list of basic medicines (with the participation of the Medicines Market Analysis Council under the Ministry of Healthcare);

- interact with competent authorities in order to ensure equal pricing opportunities for pharmacy chains of all forms of ownership;

- examine proposals for the improvement of pharmacy activities, including measures to promote safe, effective, high-quality and affordable medicines and prepare regulations on medicine circulation, if necessary.
The Price Control Memorandum is not a legally binding document. The legislation does not provide for any liability for non-compliance with it, in particular for any exceeding of recommended maximum retail prices. Nevertheless, business entities normally comply with the Memo provisions as stipulated by the Ministry of Healthcare, in order to avoid potential problems with the regulator. [1]

[1] http://www.belta.by/society/view/minzdrav-budet-prinimat-k-aptekam-bolee-strogie-mery-za-nesobljudenie-predelnyh-rekomenduemyh-tsen-269918-2017/?utm_source=belta&utm_medium=news&utm_campaign=accent
Also, the Ministry of Healthcare conducts direct negotiations with foreign pharmaceutical manufacturers. In 2017, the Ministry conducted negotiations with 10 foreign suppliers/manufacturers, such as: Sandoz Pharmaceuticals d.d. (Slovenia), GlaxoSmithKline Export Limited (Great Britain), PolPharma pharmaceutical factory JSC (Poland), Gedeon Richter chemical factory OJSC (Hungary), EGIS pharmaceutical factory CJSC (Hungary), Bayer Pharma AG (Germany) Abbott Products Operations A.G. (Switzerland) KRKA (Slovenia) and others. The negotiations resulted in proposals to reduce contract prices by 10% to 60% from the EGIS pharmaceutical factory CJSC (Hungary), Abbott Products Operations A.G. (Switzerland), Bayer Pharma AG (Germany) and KRKA (Slovenia) for over 40 medicines.
In fact, this way of influencing the pharmaceutical market leads to a "win-win" situation. On the one hand, Belarus has seen very few cases of prosecution of business entities for violating medicine price formation laws or antimonopoly laws. On the other hand, this method prevents price increases for medicines, which is critical, as they are socially significant. Thus, according to the data collected by the National Statistics Committee, the medicine consumer price index for the year 2017 amounted to 99.8% (as compared to December 2016) and for January 2018 it was 100.17% (as compared to January 2017). [1] We suppose that one of the factors influencing the effectiveness of this policy is that the Belarusian market is small, which allows the Ministry of Healthcare to interact directly with almost all of its participants. Therefore, such a "soft" way of regulating the pharmaceutical market in the sphere of curbing price increases will be the main direction of the work of the Ministry of Healthcare in future.

[1] http://www.belta.by/society/view/v-belarusi-prodolzhitsja-rabota-po-sderzhivaniju-tsen-na-lekarstva-289789-2018/
A large proportion of pharma- ceutical products is used in polyclin- ics, hospitals and other facilities within the public health care service. Due to this, supply of pharmaceutical products to state entities may be a top-priority goal for some pharma- ceutical companies. However, in order to be successful in selling phar- maceutical products to state entities you must have a deep insight into all the subtleties of purchasing pharma- ceutical products for public con- sumption.
All procurements of pharma- ceutical products for public sector in the Republic of Belarus are always bulk purchases. Bulk purchases of pharmaceutical products allow for signficant reductions of prices on pharmaceutical products supplied to public health care institutions, and reductions of expenses on their de- livery, which results in budget sav- ings. "Bulk purchase" is mnagement of product purchases by a manager for one or more ordering customers.

Public health care institutions are state-financed organisations, and therefore purchases of pharmaceuti- cal products for them are performed, as a rule, by means of state budget funds, and accordingly, such pur- chases are state - finenced purchases.
The peculiarities of 'bulk purchases' in the course of state procurements of phar- maceutical products as from 01.01.2017 to 31.12.2018 have been established by Decree No. 46 of the President of the Republic of Belarus dated 28.02.2017"On state procurements of patient care items, pharmaceutical products and health food".
Thus, the following peculiarities of bulk procurements of pharma- ceutical products are provided:

· the following government authorities compile lists of pharma- ceutical products to be purchased via bulk procurements and define orga- nizers (managers) of such bulk state procurements: i) Presidential Prop- erty Management Department; ii) national administration bodies; iii) state institutions subordinate to the government; iv) regional executive committees and Minsk Municipal Committee.

· BELPHARMACY, NUE and regional Pharmacy unitary enter- prises are organizers of state pur- chases of pharmaceutical products;

· organizers (BELPHARMACY, NUE or local Pharmacy enterprises) conclude agreements with suppliers of pharmaceutical products in their own names;

· customers (polyclinics, hospitals, pharmacies) accomplish pur- chases of pharmaceutical products from organizers without participat- ing in any procedures of state pur- chases.
The key feature of state purchases of pharmaceutical products in Belarus is that organizers not only carry out the procedures of state pur- chases of pharmaceutical products, but also conclude agreements with their win- ners for further sales of phar- maceutical products to health care institutions. In that way customers may pur- chase pharmaceutical prod- ucts from organizers without any additional procedures. A supply contract or a commis- sion contract (for instance) will suffice.
In doing so, BELPHARMACY, NUE carries out procedures of bulk state purchases of pharmaceutical products according to a specific stock list, within the scope of nation-wide needs, and transfers their results to regional Pharmacy enterprises,which thereafter conclude contracts with winners for further sales of pharma- ceutical products to health care insti- tutions. Regional Pharmacy enter- prises, in turn, also carry out proce- dures of state purchases according to different stock lists of medical sup- plies within the scope of regional needs, and thereafter conclude con- tracts with winners for further sales of pharmaceutical products to health care institutions.

This procedures of 'bulk procurements' allow for significant reductions of prices on pharmaceuti- cal products supplied to public health care institutions, well-timed settlements with suppliers and main- tenance of stock reserves, and sched- uled delivery of medical supplies to health care institutions.
5.2. Subtleties of state purchases of pharmaceutical products
According to the legislation, public health care institutions must prepare applications for purchases of pharmaceutical products pursuant to the following procedure:
1. applications from health care insitutions will be forwarded to a regional public health department for informational purposes, thereaf- ter – to the regional Pharmacy enterprise (which will add its own pharma- ceutical products consumtpion figure), and then – to BELPHARMACY, NUE;

2. BELPHARMACY, NUE will aggregate all the applications and will submit the aggregate data on the national pharmaceutical products consumtpion figure to the Ministry of Public Health of the Republic of Belarus, which will be used for bulk procurements of pharmaceutical products;

3. the Ministry of Public Health of the Republic of Belarus will carry out examinations and corrections of the annual applications;

4. the Ministry of Public Health of the Republic of Belarus will then approve a plan of bulk procurements of pharmaceutical products and health food with specification of stock lists and volumes of pharma- ceutical products, an will instruct BELPHARMACY, NUE to start pro- curements of pharmaceutical prod- ucts in volumes corresponding to nation-wide needs.

5. subsequent to the results of procurement procedures, each Pharmacy enterprise will conclude agreements with the winners.
For reference: The annual plan of bulk state pur- chases of pharmaceutical prod- ucts funded from the national budget as provided for by the Ministry of Public Health of the Republic of Belarus for the year 2018 has been approved by Order No. 1005 of the Ministry of Public Health of the Republic of Belarus dated 07.09.2017.
Furthermore, pharmaceutical products not included in the annual plan may be purchased from own floating assets (for instance, domes- tic pharmaceutical products required for fee-based medical services), or from extra-budgetary resources (for- eign pharmaceutical products) [4].

BELPHARMACY, NUE and Pharmacy enterprises are entitled (if necessary) to purchase pharmaceuti- cal products and health food not included into the List of pharmaceu- tical products and health food to be purchased via bulk procurements [5].

[4] Resolution No. 18.4 of the Board of the Ministry of Public Health of the Republic of Belarus dated 22.11.2013 "On interaction of organisers and orderers in procedures of government purchases"

[5] Order No. 220 of the Ministry of Public Health of the Republic of Belarus dated 13.03.2018 "On some issues of organisation of bulk purchases of pharmaceutical products and health food"


Managers, as a rule, will arrange and carry out the following proce- dures for state purchases of pharma- ceutical products:
electronic auction;
open competition;
call for bids procedure;
single source buying procedure
Such procedures of state pur- chases are carried out without any peculiarities pursuant to the Law of the Republic of Belarus No. 419-З dated 13.07.2012 "On government purchases of goods (works, services)".
Www.icetrade.by is the official Internet site furnishing information on state purchases and specifically on bulk purchases of pharmaceutical products. Today, www.icetrade.by is a unified national information re- source providing data on needs and purchases by enterprises and organi- sations of the Republic of Belarus.
This official website contains such information as:
• annual plans of state purchases, calls for bids in purchases (including government pur- chases), messages about the results of such purchases, documents on purchase procedures, and amendments to such documents;
• information on agreements/contracts, and amend- ments in them;
• register of unconscientious suppliers;
• register of persons accredited on the official site;
• hyperlinks to publications of regulatory acts on purchases procedures, including govern- ment purchases,
• other information.
Purchases of pharmaceutical products via electronic auctions are conducted at the electronic trading site zakupki.butb.by, operated by Belarusian Multi-Use Commodity Exchange, LLC.
More detailed information on participation in government purchases (and specifically, of pharma- ceutical products) conducted by the mentioned electronic trading site is given by the following links:
• for residents of the Republic of Belarus:

http://zakupki.butb.by/auctions/t emplate_docs/download/user_m emo_rb.pdf

• for residents of the Russian Federation:

http://zakupki.butb.by/auctions/t
emplate_docs/download/user_m emo_notresident.pdf

• for residents of other states:
http://zakupki.butb.by/auctions/t emplate_docs/download/user_m emo_world.pdf
[1] These are the countries enjoying the 'national regime' at the moment: Russian Federation, Republic of Armenia, Republic of Kazakhstan, and Kyrgyz Republic.
5.3. Application of preferential amendment
A participant of the government purchase procedure may apply a preferential amendment to any bid price. The 'preferential amendment' means granting preference to partic- ular goods/products (works, services) offered by participants, when assess- ing and comparing the bids.
In any purchase procedure, the bid prices of a participant entitled to a preferential amendment will be compared with other participants' bids net of such preferential amendment.
[1] These are the countries enjoying the 'national regime' at the moment: Russian Federation, Republic of Armenia, Republic of Kazakhstan, and Kyrgyz Republic.
Example. A batch of a phar- maceutical product of Belarusian manufacture at the price of 10,000 BYN and a batch of prod- ucts of German manufacture at the price of 9,000 BYN are par- ticipants of a government pur- chase procedure. Applying the preferential amendment at the rate of 15%, we obtain the fol- lowing actual bid price:

10,000 – 10,000*0.15 = 8,500 BYN.

Thus, despite the fact that the actual price of Belarusian products is higher, the Belarusian batch will be preferred.
Special requirements are established in Belarus pertaining to advertisements of pharmaceutical products. These special requirements shall be complied with along with the general requirements to advertising.

'Advertising' is information on the subject of the advertisement distributed in any form via any means and aiming at attracting attention to its subject, forming or maintaining interest towards it, and its promotion in the market.
The peculiarities of adver- tisements of pharmaceutical products have been established by Law of the Republic of Belarus No. 225-З dated 10.05.2007 "On advertising", and by Resolution No. 63 of the Ministry of Public Health of the Republic of Belarus dated 23.07.2013.
Any violation of advirtising requirements will entail administra- tive liability by way of penalty: for natural persons – up to 30 basic units (735 Belarusian roubles, or ca. 360 USD); for IEs – up to 40 basic units (980 Belarusian roubles, or ca. 480 USD); for an entity – up to 50 basic units (1,225 Belarusian roubles, or ca. 600 USD) [1].

[1] P. 1, art. 12.15 CoAO
The following peculiarities of pharmaceutical products advertising exist in Belarus:
1. Advertisements must be ap- proved by MPH.
According tothe general rule, any and all advertisements of phar- maceutical products in Belarus must be approved by the MPH2. in order to obtain such approval, you need to file a request to MPH together with sam- ples of advertising materials, drug package insert,history of its use and a confirmation of veracity of the advert.

MPH will decide on advert approval within a term from 15 days to 1 month (if an expert advice re- garding the advert is needed). The effective duration of such approval is 1 year [1].

[1] Cl. 10.19 of the Catalogue of administrative procedures
You do not need approval for adverts of pharmaceutical products in the following cases:

▪ in venues of medical or pharmaceutical exhibitions, workshops, conferences, and similar events, where advert information is furnished only to medical and pharmaceutical specialists;

▪ in specialised print publica- tions,approved by MPH3 [1].

[1] Resolution No. 63 of the Ministry of Public Health of the Republic of Belarus dated 23.07.2013
2. Prohibition of advertising
You can advertise only regis- tered pharmaceutical products. The only exception is advertising of non- registered pharmaceutical products during their clinical trials for state registration. Such advertising is aimed at engaging volunteers (pa- tients) to participate in such clinical trials.

Any distribution of adverts of pharmaceutical products sold only on prescription is allowed only in specialised print publications and venues of medical or pharmaceutical exhibitions, workshops, conferences, and similar events.
3. Content of adverts of pharma- ceutical products.
The list of requirements to the contents (and prohibitions on con- tent) of adverts of pharmaceutical products is very broad. The table below provides a number of exam- ples ofsuch requirements (the pre- sented lists are not exhaustive).

В таблице приведены ряд примеров таких требований, приведенные перечни не являются исчерпывающими.
'Promotion' is an activity carried out, arranged or sponsored by a phar- maceutical company in any form, using various communication chan- nels (including Internet) and aiming at contributing to attracting attention, forming or maintaining demand, prescription, recommendations, supplies, sales, application, assigning and/or use of pharmaceutical prod- ucts of a company [1].

[1] Code of practice of the Association of international pharmaceutical manufacturers (Belarus) http://baipm.com/
1.
Activities of pharmaceutical representatives
Activities of representatives of pharmaceutical companies who inform clients of the products is one of the means to promote pharmaceu- tical products.
Procedures and terms of in- formation sharing by medical and pharmaceutical special- ists with regard to pharma- ceutical products included in the State register of pharma- ceutical products of the Republic of Belarus by repre- sentatives of manufacturers of pharmaceutical products are regulated by Resolution No. 44 of the Ministry of Public Health of the Republic of Belarus dated 17.04.2015 (hereinafter – Resolution No.44).
Such information sharing may be carried out only by the following representatives:

· having a university degree in Medicine or Pharmacy;
· who are competent in pharmaceutical products circulation.
The law provides for the following legitimate forms of information sharing:
1
oral presentation involving (or not involving) demonstration of information or other materials on pharmaceutical products during meetings, conferences, workshops, simposiums and other events specified by the director of the respective health care institution;
2
placing information materials on pharmaceutical products in places specified by the director of the respective health care institution.
In promoting pharmaceutical products, you should take into ac- count the existing prohibitions for representatives. These are:
· be present and/or to speak at any events not specified by host institution head;
· place (distribute) information materials in any places not specified by host institution head;
· enter offices or other working spaces of the host institution or otherwise distract workers' attention away from their job duties;
· distribute (furnish) any samples of pharmaceutical products, either for a compensation or free of charge;
· carry out and activi- ties/actions aiming at creating work- ers' interest in ordering or selling pharmaceutical products to patients.
2.
Anti-corruption regulations
Anti-corruption laws restrict promotion of pharmaceutical prod- ucts in cases where such activities affect relations involving administra- tive officials.
Prohibitions and restrictions withregard to medical and pharmaceutical specialists who are administrative offi- cials have been established by Law of the Republic of Belarus No. 305-З dated 15.07.2015 "On fighting corruption" (hereinafter – the Anti-Corruption Law).
'Administrative officials' are:
1
government administrative officials
2
persons equivalent to admin- istrative officials
Let us examine the main prohi- bitions and restrictions as estab- lished by the Anti-Corruption Law.
Importation (exportation) of pharmaceutical products in/from the territory of the Republic of Belarus is controlled by the state.
Procedures for importation (exportation) of pharmaceuti- cal products are regulated by Law of the Republic of Belarus No. 161-З dated 20.07.2006 "On pharmaceuti- cal products" (hereinafter – the Pharmaceutical Products Law).
Only the following pharmaceutical products may be imported in the Republic of Belarus:

  • registered in the Republic of Belarus;
  • with effective period of validity;
  • of good quality,not forged.
Importation of non-registered pharmaceutical products is allowed in restricted cases only.The following pharmaceutical products may be imported without registration:
  • intended for preclinical stud- ies;
  • for state registration;
  • for use as exhibition samples;
  • for clinical trials;
  • imported by natural persons for individual use;
  • used to cure restricted cohorts of patients with uncommon pathologies;
  • used to mitigate effects of emergency conditions or epidemic diseases;
  • imported as foreign gratis aid;
  • imported pursuant to the requirements of customs laws of the Eurasian Economic Union (if placed under the customs procedures of: processing in the customs territory, customs warehouse, free economic zone, free warehouse, destruction, or customs transit) [1].
[1] Regulation on importation of pharmaceutical products in the customs territory of the Eurasian Economic Union, approved by Decision of the Board of Eurasian Economic Commission No. 30 dated 21.04.2015 "On non-tariff regulation measures"
Regarding exportation, the current legislation does not provide for any particular requirements in this respect. There is only one pecu- liarity: if pharmaceutical products are intended exclusively for commercial production for export, they cannot be registered in Belarus.
7.1. Opinion letter for importing pharmaceutical products
In some instances, in order to import registered (or non-registered) pharmaceutical products in the Republic of Belarus, you will need an opinion letter (a permit) of the Ministry of Public Health.
Procedure for release of MPH opinion letters for importa- tion of pharmaceutical prod- ucts have been established by the Regulation on procedures and terms of release of MPH opinion letters (permits) for importation of pharmaceuti- cal products and pharmaceu- tical substances controlled by Belarusian Frontier Service due to non-economic reasons, as approved by Resolution of the Council of Ministers of the Republic of Belarus No.1397 dated 23.09.2008.
In particular, you will need such an opinion letter when importing non-registered pharmaceutical prod- ucts, and also pharmaceutical prod- ucts delivered:
• as aid/supplies in emergency situations or epidemic diseases;
• for state re-registration or amendments of registration dossiers;
• for delivery of health care during international sports events;
• to be used as exhibition samples;
• as foreign gratis aid.
Such opinion letters are issued by MPH. The national unitary enter- prise "Centre of evaluations and trials in public health service" (hereinafter – the Expert Evaluation Centre) ac- cepts and examines required docu- ments and issues opinion letters for importation of pharmaceutical prod- ucts. Opinion letters are issued within 20 calendar months. Such opinion letters are valid within 6 months.
[1] According to the National Statistical Committee of the Republic of Belarus (www.belstat.gov.by)
A special procedure has been established for importation (exporta- tion) of medicinal narcotic drugs in the territory of the Republic of Belarus.
Procedures for importation (exportation) of medicinal narcotic drugs are regulated by Law of the Republic of Belarus No.408-З dated 13.07.2012 "On narcotic drugs, psychotropic sub- stances, their precursors and equivalents" (hereinafter – the Narcotic Drugs Law).
Importation (exportation) of medicinal narcotic drugs is carried out by legal entities under special permits.

Such permits are issued in respect of pharmaceutical products which are narcotic and are, as such, included in the National List [1].

[1] Resolution of the Ministry of Public Health of the Republic of Belarus No. 19 dated 11.02.2015 "On establishing a National List of narcotic drugs, psychotropic substances and their precursors subject to state control in the Republic of Belarus".
Permits in respect of narcotic pharmaceutical products included in List 1, Table 1 of List 4, and List 5 of the National List are issued in consul- tation with the Ministry of Internal Affairs of the Republic of Belarus.
Procedures for issue of such permits have been estab- lished by Resolution of the Council of Ministers of the Republic of Belarus No.1397 dated 23.09.2008 "On some issues of procedures for move- ment of particular goods across the state frontier of the Republic of Belarus".
Obtaining MPH permit is an administrative procedure provided for by cl. 10.27.1 of the Catalogue of administrative procedures. This pro- cedure will be carried out by the Expert Evaluation Centre, which is subordinated to MPH [1].

[1] This organisation's website is: www.rceth.by.
Required documents are examined free of charge within 15 calendar days.

Importation (exportation) of pharmaceutical products is also sub- ject to compliance with the require- ments of the customs laws of the Eurasian Economic Union which are clarified in the following section.

At the moment, a single EAEU market of pharmaceutical products is legislated and is rapidly growing.
The 'single market' of pharmaceutical products means that the following pharmaceutical products are freely traded within the EAEU:

I) conforming to standards of good pharmaceutical practices (laboratory, production, clinical, pharmacovigilance etc.),and
ii) registered pursuant to unified rules of registration and expert evaluation.
The single EAEU market of pharmaceutical products is regulated by the Agreement on uniform principles and rules of turnover of pharmaceutical products within EAEU of 23.12.2014. In order to regulate the procedures for the turnover of pharmaceutical products within the single market, the EAEU Committee jointly with EAEU member states prepared a package of documents which entered into force on 6 May, 2017.
Aspects unified and harmonized at the supranational level are crucial and aimed at establishing a common market of medicines. The information with regard to the issues have been unified or harmonized at the supranational level is as follows.
Setting universal requirements for medicines in all Member States is necessary for the creation of a common market. This concerns, inter alia, the introduction of the EAEU Pharmacopoeia (a set of unified specifications for medicines). Creation of the EAEU Pharmacopoeia is a complicated systemic process accomplished through the harmonization of Member States pharmacopoeias.
At present, the EAEU Pharmacopoeia is governed by the Agreement on Common Principles and Rules for Circulation of Medicines within the Eurasian Economic Union (Article 5) and the Concept for Harmonization of Member States' Pharmacopoeias, approved by Decision No. 119 of September 15, 2015 of the Board of the Eurasian Economic Commission (the EEC). [1]

[1] http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/pharmacopoeia_acts.aspx


By Decision No. 121 of September 22, 2015, [1] the EEC Board also established the EAEU Pharmacopoeia Committee, governed at present by the relevant Provisions. Its main aim is to consider and approve particular pharmacopoeia monographs which are then included in the EAEU Pharmacopoeia. The structure and composition of the Committee are described on the website of the Eurasian Economic Commission. [2]

[1] http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/pharmacopoeia_acts.aspx

[2] http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/pharmacopoeia_structure.aspx
The unified EAEU Pharmacopoeia comprises general pharmacopoeia monographs, specific pharmacopoeia monographs and pharmacopoeia monographs pertaining to medicines for veterinary use.
Harmonized general pharmacopoeia monographs are included in Volume 1 of the EAEU Pharmacopoeia and set the requirements to quality control methods pertaining to pharmaceutical products and equipment used in quality testing, packing materials, reagents, dosage forms and substances, standard samples and additive agents used in manufacturing of medicines intended for circulation on the EAEU market. To date, a draft Section 1, Volume 1 of the EAEU Pharmacopoeia has been published. [1]

[1] Legal acts pertaining to the circulation of medicines in the EAEU are available at: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx
Subsequent volumes of the EAEU Pharmacopoeia will comprise Harmonized specific pharmacopoeia monographs on pharmaceutical substances (including pharmaceutical substances for veterinary use), drug raw material of natural origin (either plant or animal), medicinal preparations and other medicines.
Another separate volume of the EAEU Pharmacopoeia will comprise Harmonized pharmacopoeia monographs on medicines for veterinary use (if they differ from the monographs on medicines for human use). Harmonized general and specific pharmacopoeia monographs not included in the next edition will be published as addenda.
Work to elaborate a unified EAEU Pharmacopoeia has been done since 2016. At present, the EAEU Pharmacopoeia Committee has approved a number of draft monographs: "Equipment," "Physical and physicochemical methods." "Impurity testing" and "Quantification methods." Other pharmacopoeia monographs still under discussion. The list of approved pharmacopoeia monographs and the list of those under consideration are available at the Eurasian Economic Commission website. [1]

[1] http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/pharmacopoeia_PO.aspx
The EAEU Pharmacopoeia requirements will be mandatory for all medicines circulating in the EAEU. They are expected to be updated at least once every five years.
8.2. Preclinical studies and clinical trials in Member States
Medicines can only be marketed in the EAEU after they have been pre-clinically and clinically tested in the EAEU Member States. Such testing shall be conducted in compliance with the unified guidelines of good laboratory practice, good clinical practice and requirements for conducting studies and trials.

Rules of good laboratory practice are laid down in Decision No. 81 of November 3, 2016 of the EEC Council [1] and shall be complied with in conducting preclinical (non-clinical) studies of the safety of medicines and the substances they contain. It is necessary for state registration of such pharmaceutical products.

[1] http://docs.eaeunion.org/docs/ru-ru/01411927/cncd_21112016_81
The EAEU Rules of good clinical practice were approved by Decision No. 79 of November 3, 2016 of the EEC Council. [1] These Rules are international ethical and scientific standard for planning and conducting research involving human subjects, as well as standards for documenting and presenting findings.

[1] https://docs.eaeunion.org/docs/ru-ru/01411924/cncd_21112016_79
As for other special procedures, the Council has already unified the Rules for conducting research in biological medicines (Decision No. 89 of November 3, 2016 of the EEC Council) and the Rules for research in bioequivalence of medicines (Decision No. 85 of November 3, 2016 of the EEC Council).
In order to freely circulate medicines on a common market in the EAEU, the Rules for registration and assessment of medicines for human use were developed, approved by Decision No. 78 of the EEC Council of November 3, 2016, and entered into force on May 6, 2017. [1]

[1] http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx
The Rules distinguish between:
1
the mutual recognition procedure (see diagram 1)
2
and the decentralized procedure (diagram 2)
Diagram 1:
Diagram 2:
Under the mutual recognition procedure, a medicine is registered in one Member State (so called "reference state"), which is proved by a registration certificate obtained in that state. Then, when this medicine is registered in other Member States (so called "states of recognition"), it undergoes a simplified procedure and also obtains a registration certificate (in the state of recognition).

The main feature of the decentralized registration procedure is that during registration, a medicine's registration dossier is analyzed in the reference state and state of recognition simultaneously. This shortens the overall time it takes to register a medicine in multiple states.
Under the decentralized procedure, national competent authorities cooperate through a special data system. At the moment, this system is still under development and is not fully functional, even though there is a regulatory framework for the decentralized procedure [1] .

[1] http://www.eurasiancommission.org/ru/nae/news/Pages/17-11-2017-1.aspx
The mutual recognition procedure is, however, fully operational, which means the EAEU Member States have undertaken to recognize the findings of preclinical (non-clinical), clinical and other studies (trials) of medicines, findings of manufacturing inspections, preclinical (non-clinical), clinical studies (trials) of medicines and pharmacovigilance systems for compliance with the rules of good pharmaceutical practice and with the requirements established by the Eurasian Economic Commission. [1]

[1] P. 7, art. 7 of the Agreement on Common Principles and Rules for Circulation of Medicinal Products within the Eurasian Economic Union of December 23, 2014.
Registration and assessment of medicines, according to rules of the Eurasian Economic Commission, shall be conducted with help of the Unified Nomenclature of Dosage Forms (as approved by Decision No. 172 of December 22, 2015 of the EEC Board).
All medicines duly registered and placed in the EAEU market must have labels in accordance with the Unified Labeling Requirements for medicines for human use and for veterinary use (approved by Decision No. 76 of November 3, 2016 of the EEC Council).
These medicines also must have package leaflets according to the Unified Requirements (approved by Decision No. 88 of November 3, 2016 of the EEC Council).

To ensure harmonization of national pharmaceutical markets, Member States have established transitional periods. That will allow for gradual substitution of national regulation with the supranational rules of the EAEU.
8.4. Pharmaceutical manufacturing
Pharmaceutical manufacturing in the EAEU is governed by the Rules of good manufacturing practice (approved by Decision No. 77 of November 3, 2016 of the EEC Council), which entered into force on May 6, 2017.
These Rules set out requirements for manufacturing medicines for both human and veterinary use. They are mandatory for all EAEU manufacturers and are always complied with for the purposes of licensing and conducting inspections.

The Rules do not apply to occupational safety of the personnel involved in production. Occupational safety issues may be critical for the production of highly active, biological or radioactive products, so it falls within national Member States' regulation.
The legal basis for the Qualified Person has been established as a guarantee of compliance with these rules. A Qualified Person is appointed by a manufacturer in order to ensure compliance of medicines with the requirements specified during their state registration. A Qualified Person is personally responsible for the compliance of manufacturing processes with the requirements of good manufacturing practice.
Certification for a Qualified Person is regulated by Decision No. 73 of November 3, 2016 of the EEC Council.
8.5. Wholesale trade, transportation and storage of medicines
Quality of medicines must be maintained through- out all stages of the supply chain. Therefore, the EEC Council adopted the Rules of good distribution practice which have been in force since May 6, 2017, as approved by Decision No. 80 of November 3, 2016.
These rules specify unified requirements for the distribution of medicines within the EAEU, i.e., for the procedures of procurement, storage, import, export, sales (except sales to end consumers) with- out restrictions as to volumes and transportation of medicinal products.

The rules apply to all persons/entities involved in the distribution of medicines according to their function, including distributors and manufacturers of medicines, regardless of their departmental affiliation and form of ownership.
Good distribution practice is aimed at observance of proper conditions for storage, transportation and distribution ensuring proper quality, safety and efficacy of medicines the entire supply chain. It also aims to prevent any counterfeit medicines from entering the supply chain.
Domestic legislation of the EAEU Member States still regulates some stages of medicine distribution insofar as it does not conflict with the EAEU Rules of good distribution practice. For instance, this is the case with some stages of distribution of narcotic and psychotropic drugs or their precursors, drugs classified as particularly toxic (highly toxic) compounds and drugs that are sources of ionizing radiation.
8.6. Unification of pharmaceutical inspection procedures
In order to conduct nonrecurring pharmaceutical inspections of quality systems and to acknowledge the findings of such inspections throughout all EAEU Member States, the Council of the Eurasian Economic Commission has established unified requirements for them. Such inspections determine whether manufacturing of medicines complies with the EAEU rules of good manufacturing practice.
General requirements to pharmaceutical inspections are described in Art. 10 of the Agreement on Common Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union and the Rules for Pharmaceutical Inspections approved by Decision No. 83 of November 3, 2016 of the EEC Council [1] .

[1] http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx
Pharmaceutical inspections are conducted by pharmaceutical inspectorates of the EAEU Member States. Inspectorate activity is regulated by the Common requirements for the quality system of pharmaceutical inspectorates as approved by Decision No. 82 of November 3, 2016 of the EEC Council. [1] The Eurasian Economic Commission maintains a register of pharmaceutical inspectors in the EAEU. [2]

[1] http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx

[2] https://portal.eaeunion.org/sites/odata/_layouts/15/Registry/PMM09/TableView.aspx
The timing of regular pharmaceutical inspections, the procedure for deciding on them and lists of entities qualified to conduct inspections (and that have been awarded the corresponding certificates) shall be established by the respective pharmaceutical inspectorates.
8.7. Setting common pharmacovigilance requirements
The pharmacovigilance system is designed to reveal, assess, interpret and prevent unwanted sequences of medicines use. Requirements for the pharmacovigilance system have been established by the EAEU Rules of good pharmacovigilance practice as approved by Decision No. 87 of November 3, 2016 of the EEC Council. [1]

[1] https://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87
All companies must develop and implement their own pharmacovigilance systems in order to monitor the safety of medicines. The chief executive officers of such companies are responsible for the creation and proper functioning of pharmacovigilance systems and for the compliance of pharmacovigilance systems with the EAEU legislation.
All specialists of corporate pharmacovigilance systems are responsible for proper functioning of quality control systems ensuring quality of medicines in terms of pharmacovigilance. Companies shall provide sufficient staffing of pharmacovigilance units and shall also prepare and implement training plans for pharmacovigilance specialists.
The competent government authorities carry out inspections of pharmacovigilance systems in companies. Such inspections may be unexpected, therefore corporate entities must always be ready for them.
8.8. Rules of competition in the single market of pharmaceutical products

General competition rules as established by the EAERU Treaty:
1
prohibition of any actions (omissions) of an economic agent (market participant) having a dominant position (i.е. where individual domination amounts to at least 35%, and collective domination to at least 50% or 70%) resulting in actual or potential exclusion, restriction, elimination of competition and/or infringement of interests of other entities/participants;
2
unfair competition is not allowed;
3
prohibition of agreements between economic agents (market participants) of member states who are market competitors acting in the same product market which actually entail or may entail certain consequences;
4
prohibition of 'vertical' agreements between economic agents (market participants), except for 'vertical' agreements which are acknowledged permissible pursuant to the permissibility criteria;
5
prohibition of other agreements between economic agents (market participants), except for 'vertical' agreements which are acknowledged permissible pursuant to the permissibility criteria, provided it has been found that such agreements actually result or may result in restriction of competition;
6
prohibition of coordination of business activities of economic agents (market participants) of member states by natural persons, business entities and non-commercial ogranisations, where such coordination actually results or may result in any of the effects specified in clauses c. and d. provided they cannot be acknowledged permissible pursuant to the permissibility criteria.
Pharmaceutical companies and distributors will have to comply with the general rules of competition when realising pharmaceutical products in the EAEU single market. For instance, if a pharmaceutical product has been entered into the EAEU Unified Register, then conclusion of a distribution agreement stipulating a territorial restriction of sales of such pharmaceutical product may contradict the general rules of competition. Thus, the clause of the distribution agreement providing for a territorial restriction of sales of pharmaceutical products only to one EAEU member state may contradict the general rules of competition.
8.9. Non-tariff regulation measures in respect of pharmaceutical products
Non-tariff regulation measures have been established in respect of particular pharmaceutical products. That means that their importation in the EAEU territory is subject to authorisation-based procedures (licensing).
The list of pharmaceutical products subject to authorisation-based procedures has been established by clause 2.14, Annex 2, as approved by Decision of the Board of Eurasian Economic Commission No. 30 dated 21.04.2015 "On non-tariff regulation measures" (herein- after–the List).
The authorisation-based procedures are not applied:
a) in respect of pharmaceutical products:
- not included in the List;

- imported by natural persons for individual use;

- kept in medicine chests of vehicles and intended for treatment of passengers and crew members;

- imported for treating participants of official international cultural and sports events and participants of international expeditions;
b) where all pharmaceutical products (without limitation to the list in clause a.) are placed under one of the following customs procedures:
- processing within customs territory;

- customs warehouse; џ free economic zone; џ free warehouse;

- destruction;

- customs transit;

- customs procedure of temporary import (admission).
The authorisation-based procedures are applied in two forms:
availability of record on a pharmaceutical product in the Unified Register or in the respective state register of pharmaceutical products of the member state;
availability of permit for importation.
Importation of registered pharmaceutical products will be allowed provided a record on respective pharmaceutical product exists in the Unified Register or in the respective state register of pharmaceutical products of the member state. In spite of the fact the Importation Regulation allows for importation of pharmaceutical products included into the EAEU Unified Register of pharmaceutical products, actually at the moment it is not possible due to the fact that the single EAEU market is not yet operating in full.
Moreover, any imports of non- registered pharmaceutical products and registered pharmaceutical products intended for: i) humanitarian aid and/or supplies for emergency situations, ii) clinical studies and/or trials, shall be supported by an official permit (authorisation document).

Such official permits (authorisation documents) are issued by MPH. acceptance and examination of documents for the issue of permits is carried out by the national unitary enterprise "Centre of evaluations and trials in public health service" (hereinafter – the Expert Evaluation Centre). The time frame for issuing such permit is 20 calendar days. Its duration is 6 months.
8.10. Peculiarities of importation (exportation) of medicinal narcotic drugs
Stricter requirements exist for importation (exportation) of medicinal narcotic drugs.
The list of medicinal narcotic drugs subject to authorisation-based procedures for importation (exportation) has been established by clause 2.12, Annex 2, as approved by Decision of the Board of Eurasian Economic Commission No. 30 dated 21.04.2015 "On non-tariff regulation measures".
Importation of all other narcotic drugs not included in this list in the EAEU territory is prohibited.
Importation of medicinal narcotic drugs is subject to special single- use import licenses. Such licenses are granted by the Ministry of Anti- Monopoly Regulation and Trade of the Republic of Belarus (hereinafter – MART), where there is a permit (authorisation document) from MPH. Permits (authorisation documents) in respect of narcotic drugs, psychotropic substances and precursors included in List 1,Table 1 of List 4, and List 5 of the National List of narcotic drugs, psychotropic substances and their precursors subject to state control in the Republic of Belarus are issued in consultation with the Ministry of Internal Affairs of the Republic of Belarus.
MPH permits (authorisation documents) will be granted subject to submission of documents for an import license. This is an administrative procedure carried out by the national unitary enterprise "Centre of evaluations and trials in public health service" [1] , which is subordinated to MPH4. Required documents are examined free of charge within 15 calendar days. Granting a license for importation of medicinal narcotic drugs by MART is also an administrative procedure carried out within 15 calendar days. The fee for the procedure is 5 basic units.

[1] www.rceth.by
Single-use licenses for importation of medicinal narcotic drugs are issued for 1 year, unless otherwise is provided for by the terms of a foreign trade contract (agreement) by virtue of which imports are made, or by the duration of the permit (authorisation document). A single-use license for importation of medicinal narcotic drugs shall particularly specify the description, the quantity and the value of imported products.
Upon expiry of a license, the importer is obliged to furnish a statement of license fulfillment to MART within 15 calendar days.
Production of license is not required in importation of [1] :
[1] Art. 15 of Narcotic Drugs Law and Annex No. 10, approved by Decision No.30.
1
medicinal narcotic drugs by natural persons to a limited extent (narcotic drugs – not more than the rate of weekly need; psychotropic substances and precursors – not more than 90 single doses, upon availability of supporting medical documents or copies thereof duly certified by a notary or by the issuing health care institution);
2
medicinal narcotic drugs, intended for emergency actions in emergency situations;
3
medicinal narcotic drugs in first-aid kits in vehicles, in limited quantities specified by the legislation of the state of registration of such vehicles (however, narcotic drugs cannot be kept in railway or motor vehicles in any circumstance).
Facts and figures about REVERA
This material has been prepared by REVERA specialists on the ground of legislation of the Republic of Belarus, as of 1 October, 2018 (unless otherwise specfied in the text),for information purposes only. No portion of this material may be reproduced in any form and by any means whatsoever without providing due references to REVERA.

Information in this review is presented in concise form.The authors are not liable for any damages inflicted to any persons because of any action or refusal to act based on any information from this review. You should always consult a specialist in a relevant field for any concrete questions.
For the purposes of this review, all money measures have been recalculated according to BYN/USD official exchange rate as of 1 October,2018 equal to 1.9442 Belarusian roubles.

Some figures were indicated using "base units" – an all-purpose economic indicator applied in Belarus in calculations of duties, taxes and other payments.As of 1October,2018,one basic unit equals to 24,5 BYN (about 12 USD).¹
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