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EU-Japanese mutual recognition agreement extends to homeopathic medicinal products

21 Sep 2018

The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites. The 2004 mutual recognition agreement allows regulators to rely on good manufacturing practice (GMP) inspections in each other’s territories, reducing the need for duplication.

This agreement has now been extended to cover, among others, homeopathic medicinal products, vitamins, minerals and herbal medicines (where considered as medicinal products by both parties). This means that the authorities from EU and Japan have agreed that they have equivalent regulatory and procedural frameworks for inspections of manufacturers for these products and can therefore rely on each other’s inspections.

While the market for these products in Japan is small, this new agreement is likely to facilitate business arrangements between concerned European and Japonese actors.