ANSM injunction: how to react?
Reply to the ANSM advance letter
On receipt of the preliminary inspection report (or a letter prior to the ANSM injunction), the offending company enters what is known as the contradictory period. During this phase, it is essential to manage communication with the inspection body effectively, responding fully and within the time limits set.
The response must be carefully drafted, firstly describing the precautionary measures put in place prior to compliance. Secondly, the operator must provide precise information and present a clear action plan to remedy the shortcomings identified. This letter also provides an opportunity to express any objections or comments on the health decision.
The ANSM then assesses the resources and protective measures taken to ensure that the corrective measures are appropriate and effective. If the solutions are sufficient, the injunction will not be adopted. If not, the company will be notified.
Responding to the injunction by building an action plan
The probationary period mentioned in the injunction takes effect on the day of notification of receipt of the injunction. At the same time, the document is also published on the national regulator’s website for public access.
During this phase, it is essential to set up milestones to monitor progress towards compliance. For example, it is advisable to :
- conduct an internal audit;
- identifying gaps
- improving procedures
- applying best practice;
- train staff;
- strengthen quality control
- strengthen validation and qualification
- introduce traceability;
- implement a monitoring and continuous improvement procedure…
The various possible outcomes of an injunction must be taken into account, whether they be regularisations, maintenance after the last deadline, cancellations or partial extensions.
Once the action plan has been implemented, the operator must provide proof of compliance during a new inspection. This will determine how the rest of the procedure will proceed.
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Impact of an ANSM injunction
Once the probationary inspection has been completed, the regulator may :
- Either declare that compliance has been fully achieved, in which case the injunction will be lifted.
- Or decide that insufficient action has been taken, and issue a formal notice.
Failure to comply with a complete procedure leads to two types of penalty:
Financial penalties
They are applied in cases where the manufacturer fails to fulfil one of its obligations or repeats a fault. It should also be noted that they can be combined with any penalty payment, but not with criminal proceedings.
Criminal penalties
In the event of non-compliance with a public health order or where human health is directly endangered, the regulatory authority may assert non-compliance with the public health code and decide to take the company to criminal court.
Faced with injunctions from the ANSM, responsiveness and vigilance are essential for pharmaceutical companies. By working closely with the regulatory authorities, companies can maintain the quality and compliance of their products, while preserving consumer confidence and ensuring public safety. By adopting a proactive and transparent approach, companies can turn regulatory challenges into opportunities for continuous improvement and sustainable growth.
FACING AN ANSM INJUNCTION?
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Source :
- ANSM : Décisions (Lignes directrices relatives aux suites d’inspection)
