Commission Directive 2009/9/ECShow full title

A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS U.K.

1. Qualitative particulars U.K.

“Qualitative particulars” of all the constituents of the immunological veterinary medicinal product shall mean the designation or description of:

• the active substance(s),

• the constituents of the adjuvants,

• the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc.,

• the constituents of the pharmaceutical form administered to animals.

These particulars shall be supplemented by any relevant data concerning the container and, where appropriate, its manner of closure, together with details of devices with which the immunological veterinary medicinal product will be used or administered and which will be delivered with the medicinal product. If the device is not delivered together with the immunological veterinary medicinal product, relevant information about the device shall be provided, where necessary for the assessment of the product.

2. “Usual terminology” U.K.

The “usual terminology”, to be used in describing the constituents of immunological veterinary medicinal products, shall mean, notwithstanding the application of the other provisions of Article 12(3)(c):

• in respect of substances which appear in the European Pharmacopoeia or, failing this, in the pharmacopoeia of one of the Member States, the main title of the monograph in question, which will be obligatory for all such substances, with reference to the pharmacopoeia concerned,

• in respect of other substances, the international non-proprietary name recommended by the World Health Organisation, which may be accompanied by another non-proprietary name or, failing these, the exact scientific designation; substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details,

• in respect of colouring matter, designation by the “E” code assigned to them in Directive 78/25/EEC.

3. Quantitative particulars U.K.

In order to give the “quantitative particulars” of the active substances of an immunological veterinary medicinal product, it is necessary to specify whenever possible the number of organisms, the specific protein content, the mass, the number of International Units (IU) or units of biological activity, either per dosage-unit or volume, and with regard to the adjuvant and to the constituents of the excipients, the mass or the volume of each of them, with due allowance for the details provided in Section B.

Where an international unit of biological activity has been defined, this shall be used.

The units of biological activity for which no published data exist shall be expressed in such a way as to provide unambiguous information on the activity of the ingredients, e.g. by stating the immunological effect on which the method of determining the dose is based.

4. Product development U.K.

An explanation shall be provided with regard to the composition, components and containers, supported by scientific data on product development. The overage, with justification thereof, shall be stated.