Medicines Act 1968

F1 58B Requirement to specify certain products for veterinary use as prescription-only products. U.K.

(1) The appropriate Ministers shall so exercise their powers under section 58(1) of this Act as to secure that every product—

(a) in respect of which a product licence is granted;

(b) to which the 1981 Directive applies; and

(c) to which subsection (2) or (3) of this section applies;

falls within one of the descriptions or classes specified for the purposes of section 58.

(2) This subsection applies to any product which—

(a) is subject to restrictions on supply or use resulting from the Narcotic Drugs Convention, the Psychotropic Substances Convention or any Community obligation (other than an obligation under the 1981 Directive); or

(b) is likely to cause unnecessary risk to the target species, humans or the environment unless special precautions are taken by a veterinary surgeon or veterinary practitioner; or

(c) is intended for a treatment or condition which requires a precise prior diagnosis; or

(d) may cause effects which impede or interfere with subsequent diagnosis or treatment.

(3) This subsection applies to any new product containing an active ingredient where a product licence for veterinary use was granted in respect of the ingredient less than five years prior to the relevant date in relation to the product unless, having regard to—

(a) the information and particulars provided by the applicant for the licence; or

(b) experience acquired in the use of the product;

the appropriate Ministers are satisfied that subsection (2) of this section does not apply to the product.

(4) For the purposes of subsection (3) of this section the relevant date in relation to a product is the date on which it falls to be determined by the appropriate Ministers whether subsection (3) applies to the product.

(5) Section 58A(5) of this Act applies for the purposes of this section.

Textual Amendments

F1 S. 58B inserted (1.1.1993) by S.I. 1992/3271, regs. 1(1),2

Modifications etc. (not altering text)

C1 S. 58B applied (1.1.1995) by S.I. 1994/3142, reg. 18