UK Guidance For New EU System For Variations

A special issue of the UK Medicines Control Agency's MAIL updating publication is devoted to the new European Union Regulations on Variations, which take effect on June 1 following the adoption of EU Commission regulations 541/95 and 542/95 last month.

The aim is to provide speedy and efficient procedures for approval of changes to marketing authorizations while maintaining adequate safeguards to public health. The new procedures relate to the MA holder's responsibility in: - updating of the MA, eg to take account of scientific and technical progress; - evolution of the product as its therapeutic role develops, eg new indications; and - ensuring safe use as new safety information becomes available.

The new system covers variations to MAs for products authorized through mutual recognition and centralized procedures, and UK national procedures for all products except PL(PI)s, registered homeopathics and clinical trial certificates. Former categories of variations will be replaced by Type I (a list of 33 minor changes, most with specific conditions to be met) and Type II (all other changes), plus an extra category of Complex Type II variations. Type I variations which present no problems will be processed within 30 days of receipt of a valid application, and Type II variations within 90 days.