Quality & complianceOfficial

BASG sets conditions for inspecting active substance manufacturers in third countries

🇦🇹 BASG · Fri 23 Oct 2026

Austria's regulator says it can inspect non-EU API sites, but only where value is added in Austria or the substance is on the Union list of critical medicines.

Austria's medicines agency BASG has updated its FAQ on third-country inspections, confirming that it can inspect active substance manufacturing outside the EU, though only if specific conditions are met. The page was last changed on 23 October 2026.

Ideally, the active substance is further processed into the finished product at an Austrian site, which BASG describes as value added. The alternative route applies where the substance appears on the current Union list of critical medicines published by the European Medicines Agency. BASG states that the mere presence of an active substance in a medicine authorised in Austria is not sufficient.

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

BASG says it acts under a sovereign mandate and can in principle conduct GMP inspections in third countries only where manufacturing for the EU/EEA market is planned or already under way. Inspections or GMP certification sought purely for commercial reasons, with no link to an EU/EEA authorisation, cannot be carried out.

The FAQ also covers practical matters for medicinal product manufacturers. Importers should contact BASG at least nine months before a planned inspection and submit the form F_I753 through BASG eServices. Fees follow the current tariff. Travel time is charged like inspection half-days, with a flat two half-days per inspector each way for intercontinental flights. Business-class flights, local transport, accommodation, visa fees and any interpreters are payable by the importer.

What it means for your team

  • Teams relying on non-EU API sites should check whether the substance is on the Union list of critical medicines or has Austrian value-added processing before expecting a BASG inspection.
  • Make sure a dossier is filed with a European authority and approved specifications are available for process validation before requesting an inspection.
  • For third-country medicinal product sites, importers should approach BASG at least nine months ahead and budget for travel, accommodation, visa and interpreter costs.

Official source: BASG ↗

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

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