PharmacovigilanceOfficial

BASG adds FAQ entry on handling requests to add safety wording already in product texts

🇦🇹 BASG · Mon 09 Nov 2026

Austria's medicines agency has published a pharmacovigilance FAQ entry on how marketing authorisation holders should respond when asked to add safety wording that their product information already contains.

The Austrian Federal Office for Safety in Health Care (BASG) has published a new entry in its pharmacovigilance FAQ, under the heading covering implementation of PHV issues, DHPCs and educational material. The entry is dated 9 November 2026.

The question addressed is what a marketing authorisation holder should do when it is asked to include safety-related wording in the product information, but that wording is already in its texts. The material available to VigiEye shows only the question, so BASG's actual answer cannot be reported here.

The entry sits in a wider FAQ section on pharmacovigilance. That section also covers periodic safety update reports (PSURs), the PSUR repository, risk management plans, the pharmacovigilance system, adverse reaction reporting routes and medication errors.

The surrounding page also sets out existing PSUR expectations. Holders must follow the data lock points and submission dates in the EURD list where the active substance appears there, and must check that list monthly for changes. Generics and well-established-use authorisations are generally exempt from routine PSUR submission, but BASG says they still have to monitor pharmacovigilance data under AMG §75i(1).

What it means for your team

  • Companies that receive requests to add safety wording to their product information should read BASG's full answer, which is not reproduced in the source reviewed, before replying.
  • Teams handling Austrian PHV issues, DHPCs and educational material should keep the FAQ page in their local procedures as a reference.
  • Holders of generic or other authorisations not subject to routine PSURs still carry ongoing signal-monitoring duties under Austrian law.

Official source: BASG ↗

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

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