KPMG Pharma Bulletin Issue #3, 2018 (March)

KPMG Pharma Bulletin Issue #3, 2018 (March)

Victoria Samsonova

Director, Head of Healthcare & Pharmaceuticals

KPMG in the CIS



Pharmaceuticals to be exempt from mandatory quality compliance confirmation

The State Duma adopted in the first reading the draft Law # 374838-7 “On Amendments to Certain Legislative Acts of the Russian Federation regarding Introduction into Civil Circulation of Pharmaceuticals for Medical Purposes”.

Currently, introduction of Pharmaceuticals into civil circulation requires mandatory declaration or certification performed by an authorized (accredited) testing laboratory. The draft amends the currently effective technical regulations by removing pharmaceuticals from the list of goods subject to the mandatory quality compliance confirmation.


Procedure for pharmaceuticals production licensing is amended

On 06.03.2018 the Russian Ministry of Justice registered the Order of the Russian Ministry for Industry and Trade # 3670 dd. 20.10.2017 which amends the Ministry’s Administrative Regulation related to rendering public services in area of pharmaceuticals production licensing.

In particular, the provision is added which restricts the following rights of the Ministry for Industry and Trade:

− to refuse from rendering the public service on licensing, if the necessary application and supporting documents were filed in accordance with the established deadlines and procedures for providing the public service (as published at the Portal);

− to request from an applicant to submit documents confirming payment of the state duty for the licensing service.


Regulations on biobanks adopted

Requirements governing biobanks’ activities have been adopted, along with the regulations to storage of biological material, biomedical cellular products, cells for producing cell lines, and cell lines intended for BMCP production. The Russian Ministry of Justice registered on 28.03.2018the corresponding Order of the Russian Ministry for Industry and Trade # 842н dd. 20.10.2017.

Biobanks are to be set up for the purposes of storing biological items and BMCP by developers, producers and clinical trials operators.

Entities participating in BMCP circulation must ensure due storage conditions in biobanks, necessary for saving the biological characteristics and preventing infection and contamination.

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List of controlled narcotic drugs and psychotropic substances extended

The Prime Minister signed the Government Decree #337 dd. 28.03.2018 that amends certain legislative acts regulating narcotic drugs and psychotropic substances circulation, in particular, extending the corresponding legislative lists.

This amendment is necessary for bringing the Russian legislation in line with the international one in area of control over circulation of narcotic drugs, psychotropic substance and their precursors.


Rules affirmed for confirming purposes of import for the goods to be used in pharmaceuticals production

The Russian Ministry for Industry and Trade approved the procedure for confirming the special purpose of import for goods intended for pharmaceuticals production by the internal Order # 462 dd. 14.02.2018 (registered by the Russian Ministry of Justice on 15.03.2018).

Pharmaceutical manufacturers are to submit to the Ministry for Industry and Trade an application in free form. The document issued by the Ministry and affirming the purpose of use of the imported goods is valid within 1 year.


Information reportable to USAIS for accounting ethanol substance is specified

The Order of the Russian Government dd. 24.03.2018 # 324 “On Amendments to the Order of the Government of the Russian Federation dd. 29.12.2015 N 1459” specifies the list of information subject to reporting to USAIS (Unified State Automated Information System) for accounting of ethanol substance.

Such information includes:

− the data from the purchase order (including purchases for own use) for ethyl alcohol and non-prepacked alcohol-containing products where ethanol share exceeds 25% of the finished goods volume;
− full name, residence address and tax registration number – for individual entrepreneurs or agricultural producers conducting business without a legal entity incorporation;
− legal name, actual address – for manufacturing companies, including those operating in the EAEU;
− country of the goods origin.


Rules for transportation of narcotic drugs and psychotropic substances to be changed

The Russian Ministry of Healthcare developed new rules for the transportation of narcotic drugs and psychotropic substances, to exempt carriers from the requirement to obtain permission for security activities. The draft Government resolution is posted for public discussions.

According to the amended rules, security of narcotic drugs, psychotropic substances and their precursors must be ensured by the entity transporting them via engaging specialized providers (the National Guard troops or subordinated organizations, in-house security service of federal government bodies or companies licensed for security activities).

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Ministry of Healthcare amended OMI rules

The Russian Ministry of Healthcare posted for public discussions the draft Order «On Approval of the Rules of Obligatory Medical insurance».

The draft clarifies the procedure for information support of insured persons at all stages of medical care. In particular, healthcare providers are supposed to provide all necessary information to medical insurance companies to enable the latter perform their obligations on distributing information on undergoing medical check-ups and preventive medical examinations.

In addition, it is planned to process applications for selecting or change of a medical insurance provider via multi-functional centers, as well as to issue OMI policies or temporary insurance certificates.


Government plans to expand subsidies for healthcare projects

1. Subsidizing development of improved analogues of innovative medicines

The Ministry of Industry and Trade posted for public discussion the draft Resolution of the Government “On Amendments to the Rules for Granting Subsidies from the Federal Budget to Russian Legal Entities for Partial Reimbursement of Expenses for Projects on Organizing and Conducting Clinical Trials of Medical Products under the Sub-Program "Development of Pharmaceutical Production" of the State Program of the Russian Federation "Development of Pharmaceutical and Medical Industry” for 2013-2020”.

The draft resolution provides for an increase of subsidies up to 75% of the costs actually incurred by Russian companies registered and located in the Territories of Advanced Social and Economic Development (TASED) and for projects where the developed innovative pharmaceutical is intended exclusively for treatment of minors / juvenile.

2. Subsidizing projects related to rehabilitation products

The Ministry posted for public discussions the draft Resolution of the Russian Government “On Approval of the Rules for Granting Subsidies to Russian Legal Entities for Partial Reimbursement of Expenses for Approbation (Pilot Operation) of Innovative Products for Rehabilitation with Participation of Disabled Persons ”.

The draft resolution provides for granting subsidies to Russian companies to compensate up to 50% of the costs for testing (pilot operation) of rehabilitation products with the participation of disabled people.


Frequency of FAS inspections will depend on the risk category of companies

The Prime Minister signed the Resolution of the Russian Government # 213 dd. 01.03.2018 approving criteria for classifying activities of companies and individual entrepreneurs per risk category for the purposes of scheduled FAS inspections.

The resolution establishes medium, moderate and low risk categories.

Companies having generated revenues of more than 10 billion rubles in the previous year, operating in areas of production and distribution of pharmaceuticals and medical devices, and provision of medical services, are assigned moderate risk category and may be subject to scheduled inspections by FAS not more than once in five years.


Criminal liability to be applied for breaching public procurement regulations

The State Duma adopted in the first reading the Draft Law № 410960-7 “On Amendments to the Russian Criminal Code and the Article 151 of the Russian Code of Criminal Procedure” establishing criminal liability for breaches in public procurement field.

Employees of contract service, members of procurement commission, persons in charge of the procured goods receipt could face a fine of up to 200 thousand rubles (USD 3,260) or imprisonment for up to 3 years.
Bribing an employee of contract service, a contract manager, a member of procurement commission can be penalized by a fine from 300 to 500 thousand rubles (USD 4,900 – 8,150) or by imprisonment for up to 3 years with a fine up to tenfold bribe amount.

The imprisonment term and penalties are increased if the offence is committed by a group of persons under previous concert.

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The previous Pharma Bulletin issues are accessible our site.

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