Division 1 Scope

Except as provided for in clause 2, Exclusions, the provisions of this Annex cover medicinal products, active pharmaceutical ingredients, pharmaceutical excipients or mixtures thereof, for human or veterinary use, to which Good Manufacturing Practice (GMP) requirements apply and that are governed by the requirements of relevant legislation notified by each party to the other under Section I of this Annex directly distributed by the manufacturer or importer of one Party to the importer of the other party.

This includes chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, and herbal medicinal products.

The provisions of this Annex shall apply to products covered by it irrespective of their origin.