The Medicines (Labelling) Amendment Regulations 1992
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.