Citation

Isaacs AJ. Int. Clin. Psychopharmacol. 1988; 3(Suppl 1): 141-143.

Affiliation

Medicines Division, DHSS, London, England.

Copyright

(Copyright © 1988, Lippincott Williams and Wilkins)

DOI

unavailable

PMID

3403947

Abstract

The UK Licensing Authority, aided by advice from expert committees, has the statutory duty to evaluate new medicines in respect of quality, safety and efficacy. All drug applications in the EC must now be accompanied by a summary of product characteristics which includes a statement on the effects of the products on the ability to drive and operate machinery. Any claims or warnings made in this or other respects must be based on data resulting from scientific experiments and will appear in data sheets. Appropriate label warnings may also be required, in some cases imposed by the Labelling Regulations, such as the standard antihistamine warning. The use of package inserts to give further warning to the public is currently under study.

Language: en