Division 1.2 ExcipientsF1

The general and specific monographs of the European Pharmacopoeia shall be applicable to all substances appearing in it.

Excipients shall comply with the requirements of the appropriate European Pharmacopoeia monograph. Where such a monograph does not exist reference may be made to the pharmacopoeia of a Member State. In the absence of such a monograph reference may be made to the pharmacopoeia of a third country. In this case the suitability of this monograph shall be demonstrated. Where appropriate, additional tests to control parameters such as particle size, sterility, residual solvents shall supplement the requirements of the monograph. In the absence of a pharmacopoeial monograph a specification shall be proposed and justified. The requirements for specifications as set out in section 1.1.2 (a to e) for the active substance shall be followed. The proposed methods and their supporting validation data shall be presented.

Colouring matters for inclusion in veterinary medicinal products shall satisfy the requirements of Directive 78/25/EEC, except for certain veterinary medicinal products for topical use, such as insecticidal collars and ear tags, where the use of other colouring matters is justified.

Colouring matters shall meet the purity criteria as laid down in Commission Directive 95/45/EC ^f1 .

For novel excipients, that is to say excipient(s) used for the first time in a veterinary medicinal product or by a new route of administration, details of manufacture, characterisation, and controls, with cross references to supporting safety data, both clinical and non-clinical, shall be provided.