Quality & complianceOfficial

BASG sets out when it can inspect third-country manufacturing sites for EU products

🇦🇹 BASG · Fri 23 Oct 2026

Austria's medicines authority has published an FAQ on third-country GMP inspections, covering eligibility, timing, importer duties and how travel and inspection costs are charged.

BASG, the Austrian medicines authority, has published an FAQ explaining when it can carry out GMP inspections at manufacturing sites outside the EU/EEA. The page was last updated on 23 October 2026.

For finished medicines, BASG says it can inspect a third-country site 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. For national or MRP/DCP authorisations, it can inspect where import into the EU/EEA, including batch release by the qualified person, takes place in Austria.

Active substance sites are covered with conditions. Ideally, further processing into the finished product should take place at an Austrian site. Alternatively, BASG points to substances listed on the current Union list of critical medicines. The fact that a substance is used in a medicine authorised in Austria is not enough on its own.

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, it says, the manufacturing process cannot be properly assessed. Inspections or GMP certification sought purely for commercial reasons, with no link to an EU/EEA authorisation, will not be carried out.

Importers must be based in Austria and should tell BASG about the need for an inspection as early as possible. BASG recommends making contact at least nine months beforehand. They must submit the form F_I753 (documentation on the third-country manufacturer) and set up BASG eServices access if they do not already have it.

Fees follow the applicable tariff. Travel time is charged like inspection half-days, with a flat two half-days per inspector for each direction of an intercontinental flight. Extra travel from the airport to the site and daily transfers longer than 30 minutes are also charged. The importer bears the costs of transport, including business-class flights and local travel, accommodation, visa fees and any interpreters.

What it means for your team

  • Companies planning EU/EEA supply via Austria should contact BASG at least nine months before an intended third-country inspection.
  • Inspection requests need a link to an EU/EEA marketing authorisation; dossier submission and approved specifications for process validation must be in place.
  • Active substance inspections are limited: an Austrian site for further processing, or a substance on the Union list of critical medicines, is needed.
  • Importers should budget for travel-time charges plus business-class flights, accommodation, visas and interpreters on top of the tariff fees.

Official source: BASG ↗

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

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