TITLE IISCOPE

F1Article 3

1.

This Directive shall not apply to:

(a)

medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community 11 ;

(b)

inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality;

(c)

veterinary medicinal products based on radio-active isotopes;

(d)

any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs 12 where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive; and

(e)

without prejudice to Article 95, medicinal products for veterinary use intended for research and development trials.

However, medicated feedingstuffs referred to in subparagraph (a) may be prepared only from pre-mixes that have been authorised under this Directive.

2.

Except for the provisions on the possession, prescription, dispensing and administration of veterinary medicinal products, this Directive shall not apply to:

(a)

any medicinal product prepared in a pharmacy in accordance with a veterinary prescription for an individual animal or a small group of animals, commonly known as the magistral formula; and

(b)

any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the end-user, commonly known as the officinal formula.