Market release of medicinal products from Japan

Can products manufactured in Japan be released in Switzerland without further analysis?

According to Art. 8 of the Swiss Medicinal Products Licensing Ordinance (AMBV), further analysis must be carried out on ready-to-use medicinal products if the country of the manufacturing site has no mutual recognition agreement with Switzerland on GMP control systems; or if there are reasonable doubts about the safety or quality of the batches to be imported. As Swissmedic considers the GMP control system to be equivalent to the Swiss GMP control system, further analysis will not be required, in most cases, for products manufactured in Japan, (see Swissmedic guideline «Requirements of quality documentation for Asian medicinal products ». The Responsible Person for technical matters (FvP) for the Swiss marketing authorisation holder can therefore accept the technical release made in Japan without further analysis. This procedure applies to all non-EU countries with equivalent GMP control systems.

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Dr. Katharina Oehler
Scientific and Managing Director

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