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UK

Advertisements for pharmaceuticals aimed at healthcare professionals must follow the general rules which apply to all advertisements for medicines. There are also specific rules for advertisements targeting healthcare professionals who are "persons qualified to prescribe or supply" (PQPS).

The general rules prohibit the advertisement of unlicensed medicines. In limited circumstances some factual information can be disseminated before the licence for a medicine is granted. Price lists can be sent by manufacturers and suppliers of unlicensed medicines ('specials') to healthcare professionals to whom the price of specials may be relevant but the price list must only contain factual information regarding the active ingredient, dosage form, strength etc and must not contain any product claims. The prohibition on advertising unlicensed medicines does not prevent the provision of a factual answer to an unsolicited question about an unlicensed medicine.

All advertisements for medicines must also comply with quality standards:

• the advertisement must comply with the particular listed in the summary of the product characteristics;
• the advertisement must present the product objectively without exaggerating its properties to encourage the rational use of the product; and
• the advertisement must not be misleading. Advertisements must not state or imply that a product is "safe" as all medicines have the potential for side-effects.

A copy of all advertisements must be kept for a minimum of three years following the last use of the piece.

Advertisements to PQPS must contain certain particulars including the name and classification of the product, a list of the active ingredients, licensed indications, side-effects and contra-indications and dosage and method of use. The information should convey all the key information from the summary of product characteristics and be sufficiently comprehensive to enable the reader to form an opinion as to its suitability for use.

Advertisements that are intended solely as a reminder of a product can consist solely of the product name, international non-proprietary name or trade mark. In addition written materials accompanying promotions must be accurate, up-to-date, verified and sufficiently complete for the recipient to form an opinion on the therapeutic value of the product to which it relates. It must also state the date it was drawn up or last revised.

Advertisements on the internet directed at PQPS should also comply with the Regulations and advertisements for prescription only medicines should solely be on websites directed at healthcare professionals.

Germany

Advertisements for pharmaceuticals aimed at healthcare professionals must follow the general rules which apply to all advertisements for medicines. They must also abide by specific rules for advertisements targeting professional circles including healthcare professionals such as e.g. doctors or nurses, and institutions in the healthcare sector.

The general rules prohibit the advertisement of unlicensed medicines. In limited circumstances some factual information can be disseminated before the authorisation for a medicinal product is granted. Price lists can be sent by manufacturers and suppliers of unlicensed medicines to healthcare professionals to whom the price of specials may be relevant but the price list must only contain factual information regarding the active ingredient, dosage form, strength etc and must not contain any product claims.

All advertisements for medicines must also comply with quality standards:

• the advertisement must comply with the particulars listed in the summary of the product characteristics;
• the advertisement must present the product objectively without exaggerating its properties to encourage the rational use of the product; and
• the advertisement must not be misleading. Advertisements must not state or imply that a product is "safe" as all medicines have the potential for side-effects.

Except in cases of advertising in audiovisual media, the advertisement must contain specific information about the pharmaceutical entrepreneur and the pharmaceutical, such as e.g. indications, side effects, classification.

Additionally, there are specific rules covering benefits granted to healthcare professionals and institutions for promotional purposes in connection with pharmaceuticals. Such benefits are only permitted within tightly defined limits.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

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