Regulation 63 Amendment to paragraph 50
For paragraph 50 (package leaflets) substitute—
“Labelling of small immediate packaging units of veterinary medicinal products
50.(1)Where the immediate packaging units of a veterinary medicinal product are too small to include in a legible form all of the information set out in paragraph 48, the immediate packaging must instead provide the following information—
(a)the name of the veterinary medicinal product;
(b)the quantitative particulars of the active substances contained in the product;
(c)the batch number, preceded by the word “Lot”;
(d)the expiry date, in the form ‘mm/yyyy’, preceded by the abbreviation “Exp”.
(2)The immediate packaging units mentioned in sub-paragraph (1) must be packed within outer packaging which provides the information required by paragraph 49.”.