Regulation 5 Amendment

In regulation 8 (Restrictions on placing on the market final medicated feeding stuff containing medicinal products) for paragraph (7) there shall be substituted the following paragraph:

“(7)

No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a prescription only medicine has been incorporated unless—

(a)

in the case of a feeding stuff which has not been imported, it has been manufactured in accordance with the provisions of these Regulations and with any undertaking given pursuant to regulation 3(3), or

(b)

in the case of a feeding stuff which has been imported other than from a member State, it has been manufactured in accordance with the provisions of Council Directive 90/167/EEC, or

(c)

in the case of a feeding stuff which has been imported from a member State, it complies with the provisions of Article 10.1, 1st indent, of that Council Directive.”.