Bioequivalence and Bioavailability Forum

Dear Ohlbe and Paresh!

❝ AFAIK products from Switzerland will not be accepted as reference in the EU (no exchange of information: EU Agencies cannot be sure the composition and manufacturing process of the Swiss product are the same as for the EU product).

One of our studies was accepted with a Swiss reference. Can give you the details when I’m back in Vienna.

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Edit: Dug it out. Manufacturer was ELAN Holdings Inc., Gainesville, USA for Novartis Pharma Schweiz AG, Bern, Switzerland. The reference was used according to the ‘Third Announcement for Drug Research in Humans’^[1] and the mutual recognition of Good Manufacturing Practice (GMP)-conformed production of drugs between the European Union (EU) and Switzerland.^[2] SwissMedic’s registration number (Zulassungsnummer) and the SmPC had to be provided to the BfArM where the protocol was approved in 2005.

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1. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArm) / Paul-Ehrlich-Institut (PEI): 3. Bekanntmachung zur klinischen Prüfung von Arzneimttel am Menschen (Entwurf, 4. Januar 2005)
   
2. Official Journal of the European Communities: Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment. Annex 1, Chapter 15: Medicinal products GMP Inspection and Batch Certification
   L 114/369, EN, 30.4.2002