The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998
These Regulations amend the Medicines for Human Use (Marketing Authorisation Etc.) Regulations 1994 (“the principal Regulations”) to make further provision implementing Council Directive 92/27/EEC (O.J. No. L113 of 30.4.1992) (“the Directive”) by requring necessary special warnings to be included on the packaging of relevant medicinal products containing paracetamol, and in package leaflets accompanying those products.