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Russian Ministry of Healthcare adopted regulations concerning drug quality control inspections


On 28.03.2017 Administrative regulation1 (hereinafter – the “Regulation”), outlining procedure of inspecting medical drugs circulation in the Russia, became effective. The Regulation provides for basics of checking the medical drugs compliance with relevant pharmacopeia description or the drug’s specification file. The body authorized to conduct drug inspections is the Federal Service for Supervision in Healthcare (hereinafter – “Roszdravnadzor”) and its local subdivisions.

According to the Regulation, there are two types of medical drugs compliance inspections, i.e. scheduled and random inspections. Scheduled inspections are conducted pursuant to the annual inspections’ schedule. Such schedules are annually approved by the head of the local Roszdravnadzor subdivision. Scheduled inspections may be conducted no more than once within three years. The Regulation also provides for unscheduled inspections, which can be conducted in the following cases:

  • upon expiry of the term for eliminating non-compliance with drug quality legislation established by Roszdravnadzor;
  • in case Roszdravnadzor receives information on potential public health threats;
  • in case the President, the Government or a prosecutors office requests Roszdravnadzor to proceed with unscheduled inspection;

Both scheduled and random inspections can be held via documentary or on-site examinations. As a general rule Roszdravnadzor will conduct a documentary inspection unless there are grounds for proceeding with an on-site inspection. The grounds for conducting on-site inspections are as follows:

  • in case Roszdravnadzor is unable to verify the information available to Roszdravnadzor without proceeding with an on-site inspection;
  • in case Roszdravnadzor is unable to check drugs quality on the basis of the available information.

The Regulation sets maximum term of the inspection (including the time necessary for an on-site inspection) as 20 business days. In exceptional case of a complex and long-term review, analysis or research the term of an on-site inspection can be extended for another 20 business days. Different terms are established for inspections conducted in respect of small enterprises (no more than 50 hours within one year) and micro enterprises (no more than 15 hours within one year).

According to the Regulation, during  an on-site inspection Roszdravnadzor is entitled to engage experts and expert agencies. Furthermore, the Regulation requires, that one of the company’s representatives is present during an on-site inspection.

In the course of the inspection Roszdravnadzor is entitled to:

  • request documents and information pertaining to the drug circulation (requested documents must be submitted within 10 business days upon receipt of the request by the company);
  • visit the areas and buildings used for the purposes of drug circulation;
  • select drug samples for the purpose of verifying drug quality;
  • issue warrants, stipulating company’s duty to eliminate non-compliance with drug quality legislation;
  • submit information to competent authorities upon results of recovered violations.  

According to the Regulation, Roszdravnadzor is not empowered to search company’s premises as well as seize company’s documents or other property.

After the inspection Roszdravnadzor officials draw two official inspection reports, one of which is to be handed over (or serviced) to a company’s representative. Along with making the inspection report, Roszdravnadzor is entitled to:

  • issue a warrant providing for company’s obligation to eliminate non-compliance with drug quality legislation;
  • issue an administrative violation report;
  • submit information to law enforcement bodies in case there are sufficient grounds for criminal prosecution;
  • make a decision to withdraw and destroy the unauthentic (substandard) medical drugs (provided subject to permission of the drugs owner). In case there is no consent, Roszdravnadzor is entitled to apply for a court order.

If the company does not agree with the Roszdravnadzor decision, the company is entitled to challenge such decision by filing a complaint with the relevant subdivision of Roszdravnadzor. After the complaint is registered with Roszdravnadzor it will be considered for a maximum period of 30 days.

Before the adoption of the Regulation, drug quality inspection had been conducted in accordance with the Regulation of Russian Government dated 15.10.2012 No. 10431. Unlike the aforementioned government regulation, the new Regulation has been developed in accordance with the Rules on developing administrative regulations (adopted by the Regulation of the Government of the Russian Federation dated 16.05.2011 No. 3732) and, therefore, contains detailed provisions on each stage of the drug quality control procedure.

_____

1Order of the Ministry of Healthcare of the Russian Federation dated 26.12.2016 No. 999n “Concerning approval of the Administrative regulation of the Federal Service for Supervision in Healthcare regulating the procedure of performance of the state function on state supervision over in the area of drug circulation by inspecting medical drugs circulating in the Russian Federation with regard to their compliance with applicable drug quality requirements”
2Regulation of Russian Government dated 15.10.2012 No. 1043 “Concerning approval of the Regulations on state supervision in the area of drug circulation”
3Regulation of Russian Government dated 16.05.2011 No. 373 “Concerning development and approval of administrative regulations on performance of state functions and administrative regulations on provision of state services”



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