Division 2 Exclusions

Medicinal products derived from human blood or human plasma, advanced therapy medicinal products, investigational medicinal products, homoeopathic medicinal products, medicinal gases and veterinary immunologicals are excluded from the coverage of this Annex.

The possibility of extending the coverage of this Annex to medicinal products derived from human blood or human plasma, investigational medicinal products and veterinary immunologicals shall be discussed by the Parties two years from the entry into force of this Annex.