Traduction de «Spécialité pharmaceutique à usage humain » (Français → Anglais) :

(7) Pharmaceuticals for humans that are addressed by other international agreements, to which the Community or the relevant Member State is party, or organisations, of which the Community or the relevant Member State is a member, should be excluded from the scope of this Regulation.

2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation.

– having regard to the European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2001) 404 - C5‑0592/2001 - 2001/0253 (COD)), which recognises in amendment 196 that ‘manufacturing shall be allowed if the medicinal product is intended for export to a third country that has issued a compulsory licence for that product, or when a patent is not in force and if there is a request to that effect by the competent public health authorities of that third country’,

Due to the species-specific, regional and often sporadic nature of animal diseases, the markets are, in practice, tiny when compared to those for human pharmaceuticals.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.