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Drug Regulator, MHRA, Publishes Guidance On Website Advertising

Drug Regulator, MHRA, Publishes Guidance On Website Advertising

This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”, SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC. General advice on compliance with the Advertising Regulations is given in the MHRA Blue Guide.

The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.

If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.

This guidance covers all websites for consumers, registered in the UK or aimed at the UK audience, which provide services that may lead to the prescription and supply of a POM. Such sites must not promote POMs to the public as this is in breach of UK medicines advertising legislation.
The guidance does not cover websites directed at healthcare professionals.

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FDA Convenes Meeting Regarding Online Advertising

FDA Convenes Meeting Regarding Online Advertising

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At a two-day meeting convened Thursday by the FDA, representatives from the pharmaceutical and other industries are gathering to give their opinions on how the US regulator should regulate advertising for drug products through the Internet and social media. The FDA agreed to consider formulating guidelines for online advertisements based on companies’ concerns that regulations for traditional media, particularly those involving the disclosure of side effects, may not be appropriate for the Internet.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”