Quality & complianceOfficial

BASG sets out when it can inspect third-country manufacturers, and who pays

🇦🇹 BASG · Fri 23 Oct 2026

Austria's regulator says it will carry out GMP inspections outside the EU/EEA only where a link to an EU/EEA authorisation exists, with importers bearing the costs.

Austria's medicines agency BASG has updated its FAQ on third-country inspections, last amended on 23 October 2026. It confirms that BASG can inspect the manufacture of a medicinal product outside the EU/EEA if the product holds an EU/EEA marketing authorisation and BASG is the 'Supervisory Authority' under the EMA's Compilation of Union procedures on inspections and exchange of information. For national or MRP/DCP authorisations, the condition is that import into the EU/EEA, including batch release by the Qualified Person, takes place in Austria.

For active substances, BASG says inspections are possible but subject to conditions. Ideally, further processing into the finished product should take place at an Austrian site. Alternatively, the substance must appear on the current Union list of critical medicines. The agency states that merely being an ingredient in an Austrian-authorised medicine is not enough.

BASG also requires that a marketing authorisation dossier has been submitted to a European authority, or is submitted at the same time as the inspection. Approved product specifications must be available as the basis for process validation when the inspection takes place. Without these, the agency says the manufacturing process cannot be properly assessed.

The agency acts under a sovereign mandate and can generally inspect only where manufacturing for the EU/EEA market is planned or under way. GMP inspections or certifications sought purely for economic reasons, with no link to an EU/EEA authorisation, will not be carried out.

On process, the importer must be based in Austria and should contact BASG as early as possible, with at least nine months' notice recommended. The importer submits the form F_I753 'Dokumentation Hersteller Drittland' and must have access to BASG eServices. Fees follow the applicable tariff. Travel time is charged like inspection half-days, with a flat two half-days per inspector each way for intercontinental flights, plus extra airport-to-site travel and daily transfers over 30 minutes. The importer also pays for transport (including business-class flights), accommodation, visa fees and any interpreters.

What it means for your team

  • Companies planning EU/EEA supply via Austria should engage BASG at least nine months before the intended inspection date.
  • Regulatory teams should ensure a dossier is submitted, or filed in parallel, and that approved specifications are available for process validation.
  • Active-substance sites qualify only via Austrian finished-product processing or the Union list of critical medicines.
  • Budget for inspection fees and travel costs, which fall to the importer.

Official source: BASG ↗

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

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