The Russian Ministry of Health’s draft law “On Amending Certain Legislative Acts of the Russian Federation…” (“the Draft Law”), concerning changes to the control of the circulation of medicinal products has been published on the federal portal for draft regulatory acts[1] .
Unscheduled Inspections of Production Sites
The Bill amends Federal Law No. 248-FZ of 31 July 2020 “On State Control (Supervision) and Municipal Control in the Russian Federation”. It is envisaged that the supervisory authority (the Ministry of Industry and Trade of the Russian Federation) will be able to carry out unscheduled inspections of holders of licenses for the manufacture of medicinal products within 72 hours of receiving information about violations in the manufacture of medicinal products that may cause or result in harm to the life and health of citizens. In doing so, the Ministry of Industry and Trade may not notify the entities being inspected of such an unscheduled inspection, but is obliged to notify the public prosecutor’s office. At present, the timeframe for unscheduled inspections is 24 hours, which in practice does not always allow the Ministry of Industry and Trade to apply the provisions of the law due to the geographical remoteness of production sites.
New Consequences in the Event of Serious Breaches of Licensing Requirements
The draft law also amends Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicinal Products” (the “Law on the Circulation of Medicinal Products”), supplementing it with Article 8.3, which establishes new features of the licensing of the manufacture of medicinal products for medical use, namely the possibility for the Ministry of Industry and Trade to respond more promptly to cases where serious violations are detected:
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Basis |
Consequences |
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Identification of serious violations following an assessment of the licensee’s compliance with licensing requirements, which cause or lead to a significant risk in the manufacture of medicinal products that is dangerous to human life and health, resulting in the consequences set out in Part 10 of Article 19.2 of Federal Law No. 99-FZ of 4 May 2011 “On the Licensing of Certain Types of Activities” |
Suspension of the license to manufacture medicinal products and/or suspension of the EAEU GMP certificate (if applicable) – for a period of up to 120 days[2] |
An assessment of the licensee’s compliance with licensing requirements may be carried out, inter alia, on the basis of the results of unscheduled inspections by the Ministry of Industry and Trade[3] .
At the licensee’s request, to allow for the timely rectification of violations, the period of license suspension may be extended by 60 days, but not earlier than 60 days from the date on which the Ministry of Industry and Trade adopted the decision to suspend the license.
The license may also be suspended in respect of work carried out on the manufacture of medicinal products at one or more sites of operation.
If the licensee fails to rectify the identified violations during the period of suspension of the license for the manufacture of medicinal products, the Ministry of Industry and Trade shall revoke the license and the EAEU GMP certificate within 10 working days from the day following the expiry of the suspension period.
Destruction of Medicinal Products
Amendments are being made to Article 59 of the Law on the Circulation of Medicinal Products, pursuant to which the requirement for a special license to carry out activities involving the collection, transport, processing, disposal, neutralisation and placement of waste of hazard classes I–IV is removed.
It is envisaged that the destruction of medicinal products may be carried out by any organisation at specially equipped sites, landfills and in specially equipped premises, in compliance with environmental protection requirements and in accordance with the legislation of the Russian Federation.
This innovation broadens the pool of potential contractors that can be engaged as organisations for the destruction of medicinal products, but requires tighter control over the destruction procedure itself.
Expert Opinion
The Draft Law is undergoing public consultation until 9 June 2026, and the provisions of the Draft Law are expected to come into force on the date of its official publication as law.
Should the Draft Law be adopted, pharmaceutical manufacturers are advised to take the following steps:
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conduct an audit of all production sites to ensure compliance with licensing requirements and EAEU GMP rules to minimise the risk of serious violations being detected;
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develop or update internal procedures for responding to notifications of unscheduled inspections. Appoint designated responsible persons for such instances, ensure prompt access to documentation and production premises, and establish procedures for interacting with the inspection authorities;
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for pharmaceutical manufacturers with multiple production sites to ensure compliance at each site individually, so that if non-compliance is identified at one site, production at the others can continue.
[2] Procedure for determining the duration – the duration is determined from the date of the Ministry of Industry and Trade’s decision to suspend the licence, which includes, inter alia, the duration of the measures provided for in the Rules for Conducting Pharmaceutical Inspections for Compliance with the Requirements of the EAEC GMP Rules, approved by the EEC, based on the results of the inspection, and/or the certificate of conformity of the manufacture of medicinal products for medical use with the requirements of the EAEC GMP Rules (if available), in respect of all activities covered by the licence constituting the licensed type of activity, or in respect of specific activities covered by the licence constituting the licensed type of activity.
[3] Further details on the forms of conformity assessment are set out in Article 19 of Federal Law No. 99-FZ of 4 May 2011 ‘On the Licensing of Certain Types of Activities’.