Rospotrebnadzor has approved new procedures covering sanitary and epidemiological assessments, inspections, studies, testing, investigations, toxicological and hygienic evaluations, as well as other forms of assessment of compliance with sanitary and hygiene requirements, and the issuance of related conclusions. The updated framework will replace the current rules dating back to 2007 and will come into effect on March 1, 2027.
The document expands both the scope of regulation and the range of entities it applies to. In particular, it introduces a separate annex setting out the procedure for sanitary and epidemiological investigations of infectious and parasitic diseases, occupational diseases, and large-scale non-infectious diseases (poisonings).
At the same time, the list of assessed objects has been further detailed and continues to include medical and pharmaceutical activities. It also separately highlights work involving biological substances, biological and microbiological organisms and their toxins, including pathogenic biological agents (PBA) of hazard groups I–IV, as well as newly introduced or previously unused chemical and biological substances and preparations based on them that may pose a risk to human health. This means that sanitary and epidemiological conclusions for these activities will now be issued under the updated rules.
The new framework also introduces a clearer system of differentiated timelines for conducting assessments, depending on the type of object.
In addition, the updated order sets out an exhaustive list of grounds for refusing to accept documents or carry out an assessment. These include non-compliance of documents or the object with the purpose of the application, lack of access to the facility, incomplete documentation, inaccurate information, absence of laboratory accreditation, and other reasons.
As Zhanna Logacheva, Project Lead, GR & Risk at Baikal Lobridge, notes:
The document expands both the scope of regulation and the range of entities it applies to. In particular, it introduces a separate annex setting out the procedure for sanitary and epidemiological investigations of infectious and parasitic diseases, occupational diseases, and large-scale non-infectious diseases (poisonings).
At the same time, the list of assessed objects has been further detailed and continues to include medical and pharmaceutical activities. It also separately highlights work involving biological substances, biological and microbiological organisms and their toxins, including pathogenic biological agents (PBA) of hazard groups I–IV, as well as newly introduced or previously unused chemical and biological substances and preparations based on them that may pose a risk to human health. This means that sanitary and epidemiological conclusions for these activities will now be issued under the updated rules.
The new framework also introduces a clearer system of differentiated timelines for conducting assessments, depending on the type of object.
In addition, the updated order sets out an exhaustive list of grounds for refusing to accept documents or carry out an assessment. These include non-compliance of documents or the object with the purpose of the application, lack of access to the facility, incomplete documentation, inaccurate information, absence of laboratory accreditation, and other reasons.
As Zhanna Logacheva, Project Lead, GR & Risk at Baikal Lobridge, notes:
“Importantly, the new procedure introduces an exhaustive list of grounds for refusal, which reduces discretion in decision-making. At the same time, the expanded circle of supervisory authorities may lead to closer scrutiny of pharmaceutical infrastructure, especially where facilities fall under the jurisdiction of Federal Medical-Biological Agency or other specialized bodies. Companies should review their documentation in advance to ensure compliance with the new requirements and avoid delays in obtaining approvals in 2027.”
Read more in the Pharmaceutical Bulletin.
