Explanatory note

These Regulations amend the Medicines (Labelling) Regulations 1976 “the 1976 Regulations”) implementing in part Council Directive 92/27/EEC (OJ No. L113, 30.4.1992, p.8) (“the Directive”) which, inter alia, lays down the requirements for labelling of containers and packages of medicinal products for human use for which a product licence is granted or renewed on or after 1st January 1994.

Regulations 3 and 4 (which insert the new regulations 4A(1) and the new Schedule 7 and which derive from article 2(1) of the Directive) make new provision for the labelling of packages and containers of certain medicinal products for human use (see the definitions of “product to which Chapters II to V of the 1965 Directive applies” inserted by regulation 2(4) and of “relevant medicinal product” inserted by regulation 2(5)). In respect of other medicinal products, existing provisions of the 1976 Regulations remain in force.

Different requirements apply for the labelling of small containers of medicinal products and containers which are blister packs (see the new regulation 4A(2) and (3) inserted by regulation 3, deriving from article 3(2) and (3) of the Directive). The Regulations also allow symbols, pictograms or other information to appear on such labels provided there is no promotional element (new regulation 4A(4)).

Requirements are also imposed to the effect that the particulars on the label must be legible, comprehensible and in the English language. Particulars may appear in more than one language if one language is English, and the same particulars must appear in all the languages used (see the new regulation 4C(1) inserted by regulation 3, deriving from article 4(2) of the Directive). In addition, a procedure is imposed for notifying the licensing authority of alteration to labels of relevant medicinal products (new regulation 4C(2)).

The Regulations also provide for certain information to be shown on a label where the name of a relevant medicinal product is given, where that information does not form part of that name (see the new regulation 4D inserted by regulation 3).

These Regulations also implement article 5 of Council Directive 89/343/EEC (OJ No. L142, 25.5.1989, p.16) which imposes special requirements for the labelling of radiopharmaceuticals (see the new regulation 4B and the new Schedule 8 inserted by regulations 3 and 4).

Copies of the Regulations for the Safe Transport of Radioactive Materials recommended by the International Atomic Energy Agency (referred to in the new Schedule 8) may be obtained from Government bookshops quoting ISBN 92 0 12390 8, price £19.00 net.