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AEMPS issues Circular 1/2026 on botulinum toxin medicines used for aesthetic purposes

🇪🇸 AEMPS · Thu 05 Nov 2026

Spain's medicines agency has published an informative circular on the prescribing, dispensing and use conditions for botulinum toxin medicines when used for aesthetic purposes.

The Spanish Agency for Medicines and Health Products (AEMPS) has published Circular 1/2026, an informative circular on the conditions for prescribing, dispensing and using medicines containing botulinum toxin as the active substance when they are used for aesthetic purposes. The item is dated 5 November 2026.

The circular is aimed at medicines whose active substance is botulinum toxin, and it applies where the use is aesthetic. The page available to VigiEye gives the title and classification of the document but does not reproduce its content.

As a result, the specific requirements the circular sets for prescribers, pharmacies and other parties are not detailed in the material reviewed. Nor does the available text say what has prompted the circular, whether it introduces new obligations or restates existing ones, or when any provisions take effect.

In Spain, informative circulars are one of the ways AEMPS communicates its expectations to the sector. Companies and professionals will need to consult the full document on the agency's website to establish what it requires in practice.

What it means for your team

  • Marketing authorisation holders of botulinum toxin products in Spain should read the full circular to check whether their labelling, distribution and promotional practices for aesthetic use are consistent with it.
  • Pharmacy and dispensing teams should review the circular's dispensing conditions against current procedures once they have the full text.
  • Compliance and quality teams should not rely on summaries: the requirements are not described in the available description, so the primary document is the only reliable source.

Official source: AEMPS ↗

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

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