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BASG: Third-country GMP inspections need a filed dossier; importers should make contact nine months ahead

🇦🇹 BASG · Fri 23 Oct 2026

Austria's regulator says it can inspect a third-country manufacturer only once an EU marketing authorisation dossier is submitted, or is submitted alongside the inspection, and advises early contact.

Austria's medicines agency BASG has updated its FAQ on third-country inspections, with guidance on when companies planning an EU marketing authorisation and importing via Austria should approach it. The page was last changed on 23 October 2026.

The central condition is that an inspection requires a marketing authorisation dossier to have been submitted to a European authority, or to be submitted at the same time as the inspection. The approved product specifications must also be available at the time of inspection as the basis for process validation. BASG states that without these elements the manufacturing process cannot be properly assessed.

BASG acts in an official, sovereign capacity 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. It will not conduct GMP inspections or certifications sought purely for commercial reasons with no link to an EU/EEA authorisation.

Import of the medicine must go through a company based in Austria. The importer should tell BASG about the need for an inspection as early as possible, and contact at least nine months before the planned inspection is recommended. The importer submits the required information using form F_I753_Dokumentation Hersteller Drittland and sets up access to BASG eServices if it does not already have it.

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 in each direction for intercontinental flights. Extra travel between airport and site, and daily transfers longer than 30 minutes, are also charged. Business-class flights, local transport, accommodation, visa fees and any interpreters are paid by the client, meaning the importer.

What it means for your team

  • Align the timing of any request for a BASG third-country inspection with dossier submission; the dossier must be filed before or alongside the inspection.
  • Plan to contact BASG at least nine months before the intended inspection date, and prepare form F_I753 and eServices access in advance.
  • Budget for inspection fees plus travel-related charges, including flat intercontinental travel half-days, and for transport, accommodation, visa and interpreter costs borne by the importer.
  • Do not seek a BASG inspection for purely commercial GMP certification; it needs a link to an EU/EEA authorisation.

Official source: BASG ↗

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

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