Pre-clearance

Sales information materials must be reviewed before use by an in-house promotional information supervision department that is set up independently of the promotional department, and that department approves them taking into account advice from a review and supervision committee.

An applicant must submit specimens of promotional labeling and advertising at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement, accompanied by Form FDA-2253 and a copy of the product's current professional labeling, and for drug products being considered for accelerated approval all promotional materials intended for dissemination or publication within 120 days following approval must be submitted during the preapproval review period, with later materials submitted at least 30 days prior to intended initial dissemination.

Preclearance of advertising for marketed health products is administered through an independent, self-regulatory and voluntary system, with PAAB reviewing material directed to health professionals and Advertising Standards Canada and MIJO reviewing non-prescription drug and natural health product material directed to consumers.

Member States must ensure that there are adequate and effective methods to monitor the advertising of medicinal products, and such methods may be based on a system of prior vetting (Directive 2001/83/EC, Article 97(1)); the marketing authorisation holder must keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising a sample of all advertisements emanating from its undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination (Article 98(2)). Because prior vetting is an option and not an obligation, whether it applies depends on national law, and examples in both directions have now been checked in national sources. France operates prior vetting: the ANSM states that for all medicines, whether or not subject to medical prescription, the whole body of promotional documents intended for health professionals and for the public is subject to a contrôle a priori by the ANSM, that is, before any dissemination, and that where the criteria are met the application results in a prior authorisation called a visa de publicité, while failure to meet them leads to refusal. By contrast the German Heilmittelwerbegesetz contains no prior-vetting provision at all; control under that Act operates after the fact through the criminal penalty in section 14, the administrative fine in section 15 and competition-law remedies.

The MHRA has statutory powers to require companies to submit advertising material for pre-publication vetting, has committed as a matter of policy to vet initial advertising for all new active substances, and applies vetting for a period that is normally one to three months and normally no longer than six months.

Advertisements for medical services, drugs and medical devices must be reviewed as to content by the advertising review authority before publication, and may not be published without such review.

Use of a restricted representation, that is one referring to a serious form of a disease, condition, ailment or defect, requires prior approval by the Secretary, who must approve it if satisfied the representation is accurate, balanced and not misleading, and who is taken to have approved it if no written notice is given within 60 days of the application.

A manufacturer, marketing authorisation holder or importer that intends to advertise a drug through newspapers, internet newspapers, periodicals, television or radio broadcasting, the internet, or media designated by the MFDS Commissioner must obtain prior review by the delegated advertising review body.

Switzerland has no across-the-board pre-vetting scheme: prior authorisation by Swissmedic is required only for advertising to the public under Art. 15(a) and (c) for analgesics, sleeping aids, sedatives, laxatives and anorectics where the medicinal product information mentions a potential for abuse or dependence, and, in addition, Swissmedic may require a marketing authorisation holder that has seriously or repeatedly infringed the advertising provisions to submit all planned advertising for review and approval before publication for an appropriate period.