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Regulation 24 Manufacture of medicated feedingstuffs

Original text. Later amendments are not shown.

(1)

No person shall manufacture a medicated feedingstuff unless—

(a)

subject to paragraphs (2) and (3), the medicinal component in the feedingstuff is a single authorised medicated pre-mix;

(b)

the premises on which the feedingstuff is manufactured are approved premises which—

(i)

are equipped with the necessary technical equipment;

(ii)

have suitable and adequate storage and inspection facilities; and

(iii)

are manned by staff of the type specified in Article 4.1(b) of the Medicated Feedingstuffs Directive;

and the premises, equipment and staff comply with the provisions of Article 4.1(d) of the Medicated Feedingstuffs Directive;

(c)

the feedingstuff used in the medicated feedingstuff complies with the first and second indented paragraphs, and sub-paragraph (iii) of the third indented paragraph, of Article 4.1(c) of the Medicated Feedingstuffs Directive;

(d)

any authorised medicated pre-mix used in the medicated feedingstuff is used in accordance with the third indented paragraph of Article 4.1(c) of the Medicated Feedingstuffs Directive, and the use is in accordance with sub-paragraphs (i), (ii) and (iii) of that indented paragraph;

(e)

the medicinal product contained in the medicated feedingstuff complies with the fourth indented paragraph of Article 4.1(c) of the Medicated Feedingstuffs Directive;

(f)

regular checks are carried out on the feedingstuff in accordance with the provisions of Article 4.1(e) of the Medicated Feedingstuffs Directive;

(g)

daily records are kept in accordance with the provisions of Article 4.1(f) of the Medicated Feedingstuffs Directive; and

(h)

pre-mixes and medicated feedingstuffs are stored on the approved premises in accordance with the provisions of Article 4.1(g) of the Medicated Feedingstuffs Directive.

(2)

Nothing in paragraph (1)(a) shall prohibit a person from manufacturing a medicated feedingstuff containing an authorised intermediate product if a medicated feedingstuff containing the product has been prescribed by an MFS prescription issued in accordance with the provisions of regulation 29.

(3)

Nothing in paragraph (1)(a) shall prohibit a person from manufacturing a medicated feedingstuff containing several authorised medicated pre-mixes if a medicated feedingstuff containing the pre-mixes has been prescribed by an MFS prescription issued in accordance with the provisions of regulation 29.