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COFRAC accreditation of ANSM’s Inspection Division

PUBLIÉ LE 29/02/2024 - MIS À JOUR LE 25/07/2024
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The ANSM Inspection Division has been accredited by COFRAC (accreditation N° 3-1094) in accordance with the ISO/IEC 17020 standard since July 2014. This accreditation constitutes recognition of the quality of ANSM’s inspection activities, as well as their compliance with ethics and international regulations related to impartiality, independence, and competence.


The purpose of COFRAC accreditation is to obtain recognition, through a reputed external audit body, that the Inspection Division operates in a structured fashion, and performs its activity according to internationally accepted ethics and standard practice (impartiality, independent, expertise).

It also increases the confidence that the various stakeholders (State, operators, etc.) may have in ANSM’s abilities to :
  • rely on recognised inspection expertise with the requisite high level of reliability, verified and inspected regularly via the accreditation
  • keep its technical expertise up-to-date.
To date, the inspection areas covered by the accreditation are as follows :
  • Inspections conducted within the framework of Medical Device (MDs, including in-vitro devices IVD-MDs) market surveillance
  • Inspections of sites carrying out activities for the manufacture, import, or distribution of pharmaceutical starting materials
  • Inspections of site carrying out activities for the manufacture, import, distribution, and use of medicines for human use other than biological medicines
  • Inspections of sites carrying out activities for the manufacture, import, distribution, and use of biological medicines
  • Inspections of clinical trials conducted within the framework of biomedical research
  • Inspections of pharmacovigilance system-related processes
  • Inspections of medical device vigilance system-related processes
  • Inspections carried out within the framework of the surveillance of operations authorized for licence holders in sites for activities on Microorganisms and toxins (MOTs)
  • Inspections of blood transfusion facilities
  • Inspections of breast milk banks
  • Inspections of sites carrying out preparation, storage, distribution, import, or export activities in relation to tissues, their derivatives, cells and cell therapy preparations
The types and purposes of the inspections and the enforceable technical standards (regulatory, normative, etc.) within the scope of the accreditation are identified on the accreditation certificate available on Cofrac’s website.

The Inspection Division’s policy is to issue inspection reports with the COFRAC logo in the areas covered by the accreditation. Operators are not authorised to reproduce the logo or refer to ANSM’s accreditation.

Within the scope of its accreditation, a description of the complaint handling process is available from the Inspection Division on request in writing.
ANSM reminds that it may release administrative documents in response to requests for access to administrative documents, public archives, and public information reuse ("CADA requests"), as stipulated by Article L. 311-1 of the Code of Relations between the Public and the Administration (CRPA). This policy also applies to the disclosure of administrative documents during audits (both internal and external), including Cofrac audits.

Access to these documents must adhere to legally protected rights such as medical confidentiality, industrial and commercial secrets, or privacy. Therefore, certain data in the documents provided may be redacted or anonymized to uphold these protections.