EU - Japan Mutual Recognition Agreement Sectoral Annex on Good Manufacturing Practice for Medicinal Products
Sixth Sub-committee Meeting, 14 June 2018 Joint Common Statement
The sixth meeting of sub-committee set up under the Joint Committee of the Agreement on Mutual Recognition between the EU and Japan took place through teleconference on 14 June 2018. Members of the sub-committee from both the EU and Japan participated in this meeting.
The subcommittee confirmed that both Parties have reconfirmed the equivalence of the GMP requirements and their implementation for some medicinal products.
The subcommittee reached the conclusion on the operational scope of those medicinal products. The operational scope should include the product categories such as chemical pharmaceuticals, active pharmaceutical ingredients, biological medicines such as vaccines, sterile medicinal products, homeopathic medicinal products, vitamins, minerals and herbal medicines and so on under certain conditions agreed by both Parties.