PharmacovigilanceOfficial

BASG publishes template wording on severe cutaneous adverse reactions for product information

🇦🇹 BASG · Mon 09 Nov 2026

Austria's regulator has added a standard SCAR text to its safety-wording page, pointing to CMDh minutes from the September 2026 meeting.

The Austrian Federal Office for Safety in Health Care (BASG) added an entry titled 'Severe cutaneous adverse drug reaction' to its page of template texts on 9 November 2026. It is categorised as 'Sonstiger Mustertext' (other template text).

The entry refers readers to the minutes of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) meeting of 15-17 September 2026. The linked item is described as 'Severe cutaneous adverse reactions (SCARs) Standard template wording for product information'. The BASG listing does not name the medicines or substances affected, and the extract available does not reproduce the wording itself.

BASG uses the page to publish safety information arising from pharmacovigilance procedures that must be implemented in the relevant product information. The CMDh is the EU body that coordinates such work for products authorised through mutual recognition and decentralised procedures.

Other recent entries on the page include a PRAC signal recommendation for oxacillin on the risk of drug reaction with eosinophilia and systemic symptoms (DRESS), dated 29 September 2026. There are also PSUR outcomes for diacerein, alendronic acid, cholinsalicylate and ramipril/bisoprolol, and template texts for levofloxacin, lithium and tropicamide. BASG directs queries to its pv-implementation mailbox.

What it means for your team

  • Marketing authorisation holders should open the linked CMDh minutes and template to confirm whether the SCAR wording applies to their products and what the implementation timelines are.
  • The BASG summary does not state which substances are covered, so the scope has to be checked in the source documents rather than assumed.
  • Teams handling Austrian product information should review the neighbouring entries, such as oxacillin (DRESS) and levofloxacin, for related wording changes.
  • Implementation questions can go to BASG at pv-implementation@basg.gv.at.

Official source: BASG ↗

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

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