ABSTRACT
Article 4 of the Medical Preparations (Advertising) Regulations 1993 (the 1993 Regulations) provides that a person shall not advertise a medical preparation in respect of which a product authorisation has not been granted. Article 5 of the 1993 Regulations prohibits the advertising of drugs requiring a prescription or controlled drugs. Article 8 of the 1993 Regulations provides that, in the case of advertisements to the general public, it must conform to the requirements laid down in Sched 2, which provide that those requirements are as follows: The advertisement must: (a) be set out in such a way that it is clear that the message conveyed is an
advertisement; (b) contain:
• a clear identification by name that the product being advertised is a medical preparation, as well as by the common name if the preparation contains only one active ingredient;
• the information necessary for the correct use of the medical preparation;
• a warning to read carefully the instructions on the package leaflet, or on the outer packaging, as the case may be;
(c) not contain any material which: • gives the impression that a medical consultation or surgical operation
is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
• suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another treatment or medical preparation;
• suggests that the health of the subject can be enhanced by taking the medicine;
• suggests that the health of the subject could be affected by not taking the medicine. This prohibition shall not apply to vaccination campaigns;
• is directed exclusively or principally at children; • refers to a recommendation by scientists, health professionals or
persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medical preparations;
• suggests that the medical preparation is a foodstuff, cosmetic or other consumer product;
• suggests that the safety or efficacy of the medical preparation is due to the fact that it is natural;
• could, by a description or detailed representation of a case history, lead to erroneous self diagnosis;
• refers, in improper, alarming or misleading terms, to claims of recovery;
• uses improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medical preparation on the human body or parts thereof;
• mentions that the drug has been granted a marketing authorisation.
