Advertising regulation

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

These provisions relate directly to the legal requirements under the Medicines (Advertising) Regulations 1994 discussed above (see Section 12.2.1.1). Standards for the conduct and training of company representatives are defined under the Code, together with those for acceptable gifts and the provision of hospitality by the pharmaceutical industry at meetings and other occasions. (These requirements are discussed in further detail in Sections 12.3.1.5 and 12.3.1.6.)... 

The Control of Misleading Advertisements Regulations (No. 915). London HMSO, 1988. 

The certificate for promotional material must certify that the signatories have examined the final form of the material and that in their belief it is in accordance with the requirements of the relevant advertising regulations and this Code, is not inconsistent with the marketing authorization and the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine. 

Material which is still in use must be recertified at intervals of no more than two years to ensure that it continues to conform with the relevant advertising regulations and the Code. 

The advertising of prescription only medicines to the general public is also prohibited by the Advertising Regulations. 

The prescription drug advertising regulations (21 CFR 202.1) distinguish between print and broadcast advertisements. Print advertisements must include the brief summary, which generally contains each of the risk concepts from the product s approved package labeling. Advertisements broadcast... 

Table 8. Advertising-minimum standard particulars required. Source Derived from The Medicines (Advertising) Regulations 1994 SI No. 1932. 

Within this framework, we provide below an overview of the current regulatory procedures in Europe. We address the practical aspects of regulating drug development, the MA processes and other activities such as advertising regulations in the EU. 

Palumbo FB, Mullins CD. 2002. The development of direct-to-consumer prescription drug advertising regulation. Food Drug Law J. 57 423-443. 

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