|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 0171-273 0664 Room 926|
|Facsimile 0171- 273 0109||.|
|09 March 2000|
Dear Mr Medawar,
EFEXOR ADVERTISEMENT - BMJ (Classified) 27 November 1999
Thank you for your letter of 2 December addressed to Mrs A Thyer enclosing a complaint about an advertisement for Efexor XL (venlafaxine). In particular you ask whether the MCA is satisfied that the advertisement complies with Sections 96(3)(b) and 93(7)(b) of the Medicines Act 1968.
Efexor XL was licensed in 1997 and is therefore required to have an approved summary of product characteristics (SPC) as part of its marketing authorisation. Article 4a of Directive 65/65/EEC which was inserted by article 1(2) of Council Directive 831570/EEC and amended by article 1(1) and (4) of Council Directive 89/341/EEC applies. This document replaces the need for a data sheet under UK legislation for relevant medicinal products as defined in regulation 2 of the Medicines (Advertising) Regulations 1994. Section 96 of the Medicines Act was subsequently amended by regulation 2 of SI 1995/2321 to provide that the requirements therein did not apply to relevant medicinal products.
Further amendment of the Medicines (Advertising) Regulations, by the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 [SI No. 267], has completed the implementation of Directive 92/28/EEC into UK law by, amongst other provisions, the direct implementation of Article 2 of the Directive thus allowing an advertisement to be considered for "misleadingness" under the Regulations without referral to the Medicines Act. It is MCA policy that, under normal circumstances, all advertising of relevant medicinal products will be assessed for acceptability by reference to the Advertising Regulations, which now fully implement Directive 92128/EEC, and not by reference to the Medicines Act 1968.
The MCA has been monitoring the advertising material for Efexor XL under the intensive surveillance [t ] scheme since the product was marketing in the UK and is satisfied that the material in consistent with the approved SPC, is not misleading and is therefore in compliance with regulation 3A of the Advertising Regulations. The data relating to superior efficacy over fluoxetine has been considered in the course of the assessment.
I hope this is helpful. Thank you for bringing this to our attention.
|Mrs E M Hopkins|
|Policy Manager, Advertising|
|Post Licensing Division|
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