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The ANSM has inspection powers, an important pillar of its mission to monitor the activity of operators contributing to the placing on the national or European market of the health products listed in Article L. 5311-1 of the Code of public health (CSP).

These guidelines explain the conditions under which ANSM manages the main consequences of the observations made by inspectors during inspections.

The publication of these guidelines is part of the Agency's desire to ensure the transparency of its actions and to show the consistency of its decisions. It must make it possible to guarantee the best possible predictability and legibility of the ANSM's follow-up policy.

This document may be modified to take into account changes in the ANSM's decision-making practice in the performance of its inspection missions.

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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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