RegulatoryOfficial

ANSM adds three products to France's list of pharmacy self-selection medicines

🇫🇷 ANSM · Wed 28 Oct 2026

A decision dated 27 October 2026 amends the 'médication officinale' list, adding an arnica gel and two homeopathic granule products to Annex III.

The French medicines agency ANSM has published a decision, signed on 27 October 2026 and posted online on 28 October, that amends the list of 'médication officinale' medicines. The list is provided for under Article R. 5121-202 of the French Public Health Code and covers medicines that may be placed in pharmacies where patients can select them themselves.

The decision, signed by ANSM Director General Catherine Paugam-Burtz, amends Annex III of the agency's decision of 12 May 2014, as since modified. It adds three presentations and removes none.

The additions are Arnica Montana Arrow Conseil gel in a 45 g tube (CIP code 3400930316238); Arnica Montana 9 CH Boiron granules in a pack of three 4 g tubes (CIP 3400930339206); and Dismaleo granules, also in three 4 g tubes (CIP 3400930347379).

Under Article 2, the decision is published on the ANSM website. The source text does not give an effective date or any conditions for display beyond the entries themselves.

What it means for your team

  • Marketing authorisation holders of the three named products should check the listed presentations and CIP codes against their own records.
  • Pharmacies may need to review how these presentations are displayed and stocked, in line with the amended list.
  • Regulatory teams tracking the 'médication officinale' list should update their reference copies of Annex III of the 12 May 2014 decision.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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