Quality & complianceOfficial

BASG: third-country GMP inspections need an Austrian importer and ideally nine months' notice

🇦🇹 BASG · Fri 23 Oct 2026

Austria's medicines agency says imports for EU/EEA products routed through Austria must be handled by an Austria-based company, which bears inspection costs including travel.

The Austrian Federal Office for Safety in Health Care (BASG) has updated its FAQ on third-country inspections, with the fourth entry aimed at companies that plan or already hold an EU/EEA marketing authorisation and want to import via Austria. The page was last changed on 23 October 2026.

The central requirement is that the import must go through a company based in Austria. The importer should tell BASG as early as possible if a GMP inspection is needed, and BASG recommends making contact at least nine months before the planned inspection. The importer supplies the required information and documents using form F_I753 (manufacturer documentation, third country) and must set up access to BASG's eServices if it does not yet have it.

BASG also sets out the limits of its remit. It acts under a sovereign mandate and can in principle carry out 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 economic reasons, with no link to an EU/EEA authorisation, cannot be carried out. Elsewhere on the page, BASG says an inspection presupposes that a dossier has been submitted to a European authority, or is submitted at the same time, and that approved product specifications are available as a basis for process validation. Without these, it says, the manufacturing process cannot be properly assessed.

The FAQ is explicit on costs. The procedure is charged under the current fee schedule. Travel time is billed like inspection half-days, with a flat two half-days per inspector and direction for intercontinental flights. Extra travel between airport and site, and daily transfers of more than 30 minutes, are also charged. The importer, as the client, must cover transport (including business-class flights and local transport), accommodation, visa fees and any interpreters.

What it means for your team

  • Companies planning to import through Austria need an Austria-based importer in place before inspection planning starts.
  • Contact BASG at least nine months before the intended inspection, and prepare form F_I753 and eServices access in advance.
  • Check that the dossier has been submitted to a European authority (or is submitted alongside) and that approved specifications exist for process validation, as BASG links inspection to these.
  • Build inspection travel time, flights, accommodation, visas and interpreters into budgets, as the importer bears these costs.

Official source: BASG ↗

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

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