For the purpose of the Sectoral Annex on GMP, biological pharmaceuticals include products which are not necessarily designated by the Ministry of Health, Labour and Welfare as ‘biological products’ in accordance with laws and regulations of Japan but which would be considered as biological products in the EU.
considérant que le comité mixte doit confirmer le champ d'application opérationnel de l'annexe sectorielle relative aux bonnes pratiques de fabrication des médicaments (ci-après l'«annexe sectorielle»), tel qu'établi, lors de sa 6e réunion, par le sous-comité créé au titre des dispositions de l'annexe sectorielle,