#2026-449France eases temporary medicine safety stock rules and sets publication period for small ANSM fines
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France gives the national medicines agency, ANSM, more flexibility to manage drug shortages. For medicines on the official shortage-risk list, the agency can temporarily lower required safety stock levels when there is force majeure, an objectively justified exceptional situation, or a need to cover the shortage of a therapeutic alternative. The change affects pharmaceutical companies and marketing authorization holders that must keep safety stocks. Any reduction can last up to six months and can be renewed if the problem continues. The decree also says small ANSM financial sanctions below €10,000 will stay published on the agency’s website for six months.
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Key Changes
- Allows ANSM to temporarily lower safety stock requirements for shortage-risk medicines in defined exceptional situations
- Limits each stock-threshold reduction to six months, with renewal possible if the situation continues
- Sets a six-month online publication period for ANSM financial sanctions below €10,000
Obligations
What this law requires
Marketing authorization holders and pharmaceutical companies exploiting medicines on the official shortage-risk list may request a temporary reduction of the required safety-stock threshold only where the request is justified by force majeure, an objectively justified exceptional situation, or the need to address a shortage of a therapeutic alternative.
When ANSM grants a reduction of the required safety-stock threshold for a shortage-risk medicine, the reduced threshold applies only temporarily for a maximum period of six months, renewable if the underlying situation persists.
ANSM must keep financial sanction decisions imposed under Article L. 5423-9 for amounts below €10,000 available on its website for six months from their publication date.