The Medicines (Leaflets) Amendment Regulations 1992
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.