The Medicines (Leaflets) Amendment Regulations 1992

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines (Leaflets) Regulations 1977 (“the 1977 Regulations”) by implementing in part Council Directive 92/27/EEC (OJNo.L113, 30.4.92, p.8) (“the Directive”) which, inter alia, lays down the requirements for the form and content of leaflets supplied with certain medicinal products for human use for which a product licence is granted or renewed on or after 1st January 1994.

Regulations 3 and 8 (which derive from article 7(1) of the Directive) amend the 1977 Regulations to prescribe requirements for the content of such leaflets. In respect of proprietary medicinal products other than those defined in regulation 2(4) of these Regulations as relevant medicinal products, existing provisions of the 1977 Regulations remain in force (regulations 5(2), (5), (7) and 7).

The Regulations provide that leaflets for relevant medicinal products are to be drawn up in accordance with the summary of product characteristics or the data sheet or where neither of these documents exist with the information which would be in such a summary (new regulation 4(1A) as inserted by regulation 5(2)).

The Regulations also allow leaflets for relevant medicinal products to be printed in more than one language provided one is English and the same particulars appear in each language (regulation 5(4), article 8 of the Directive), allow the licensing authority to direct in the product licence that certain therapeutic indications shall not appear on leaflets (new regulation 4(7) as inserted by regulation 5(8), article 7(2) of the Directive) and allow symbols, pictograms or other information to appear on such leaflets if there is no promotional element (new regulation 4(8) as inserted by regulation 5(8)).

The Regulations provide for certain information to be shown where the name of a relevant medicinal product is given, where that information does not form part of that name (new regulation 4(9) as inserted by regulation 5(9), article 7.1(a) of the Directive).

In addition, a procedure is imposed for notifying the licensing authority of alterations to leaflets for relevant medicinal products (regulation 6, article 10(3) of the Directive).

There are amendments to the definitions in the 1977 Regulations in consequence of these amendments (regulation 2).

These Regulations also implement article 6 of Council Directive 89/343/EEC (OJNo.L142 25.5.1989 p.16) which imposes special requirements for the leaflets supplied with proprietary medicinal products which are radiopharmaceuticals and with radiopharmaceutical-associated products (regulation 4).