Advertising regulatory controls

Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of dmg promotion and advertising and monitoring of ADR. 

Spedficalions regarding pharmaceutical premises, personnel and procedures must be followed by pharmaceutical manufacturers, distributors and retailers if they wish to obtain and retain their licence to operate. By means of these licences, dmg regulatory authorities control the activities of pharmaceutical manufacturers, importers and distributors and companies engaged in dmg promotion and advertising. 

In addition to controlling information used for promotional and advertising purposes, dmg regulatory authorities in the majority of the countries also provide independent dmg information. This is hue of Cypms, Estonia, Malaysia, the Netherlands, Tunisia, Venezuela and Zimbabwe. Dmg information is mainly disseminated via regular bulletins. Other bodies besides the DRA also provide independent information about dmgs. 

The Directive, however, does not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse... 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

The advertising control authority is the Consumer Protection Agency. The medicine regulatory authorities, however, must be involved in the procedure as professional co-authorities and their professioncd assessment of the advertisement must be accepted by the Consumer Protection Agency. 

Advertising and promotion eire controlled, and certain requirements are laid down for packaging and labelling. Much effort is expended by licence holders and the regulatory authority in this area, and a very sophisticated level of regulatory practice heis developed. 

The national regulatory authority for the control of advertising of medicinal products is the National Organisation for Medicines (EOF). It can apply fines for advertisements and promotion that do not comply with the relevant legislation. The fines increase significantly for repetitive breaches and can be up to 44 000 the company responsible can also be sanctioned to make an announcement in the press. More serious cases can result in a prison sentence of up to 6 months. 

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