Yes. BASG may inspect the manufacture of medicinal products in a third country if the product is authorised in the EU/EEA and BASG acts as the supervisory authority in accordance with the Compilation of Union Procedures on Inspections and Exchange of Information issued by the European Medicines Agency (EMA). For nationally authorised products and products authorised via the MRP/DCP procedures, BASG may also conduct such inspections where importation into the EU/EEA, including Qualified Person (QP) certification, takes place in Austria.

Yes; however, specific conditions must be met.

Ideally, the active substance should be further processed into the finished medicinal product at a manufacturing site located in Austria, thereby contributing to the value chain within Austria. Alternatively, an inspection may be considered if the active substance is included in the current Union List of Critical Medicines published by the European Medicines Agency (EMA).

The fact that an active substance is contained in a medicinal product authorised in Austria is not sufficient justification for a GMP inspection conducted by BASG.

Please note that a GMP inspection can only be meaningfully conducted once a marketing authorisation dossier has been submitted to a European authority, or is submitted concurrently with the inspection. The approved product specifications as the basis for process validation must be available at the time of the inspection. Without these prerequisites, the manufacturing process cannot be adequately assessed.

BASG acts in its official regulatory capacity and can generally only perform GMP inspections in third countries where manufacturing activities are intended for, or already authorised to supply the EU/EEA market.

GMP inspections or GMP certifications for companies located in third countries that are sought solely for commercial purposes and have no connection to an EU/EEA marketing authorisation cannot be performed.

1. The medicinal product must be imported through a company established in Austria (see FAQ 1 and FAQ 2).
2. The importer should inform BASG of the need for a GMP inspection as early as possible. Contacting BASG at least nine months before the planned inspection date is recommended.
3. The importer must submit the required information and documentation using the relevant form (F_I753) and establish access to the BASG eServices portal if such access has not already been set up.
4. Fees are charged in accordance with the applicable BASG fee regulation. Travel time is charged in the same way as inspection half-days. For intercontinental flights, a flat rate of two inspection half-days per inspector and direction of travel is applied. Additional travel time from airport to site and daily transfers longer than 30 minutes are also charged. The applicant (i.e. the importer) is responsible for the costs of business-class air travel, local transportation (e.g. taxi, rail, or rental car), accommodation, visa fees, and interpreters, where required.