5.1 Medicines
As a general note (applicable to both POMs and OTCs) advertising shall be allowed only for medicinal products for which a marketing authorisation has been issued. The content of the advertisement must correspond to data from the medicinal product summary approved in the course of the marketing authorisation and shall present only indications specified in the course of the marketing authorisation.
There are a number of requirements on the content of the advertisement set forth in the MPHMA and the Ordinance. The advertisement of a medicinal product must suggest its correct use, objectively presenting its therapeutic indications, without exaggerating the effect of the treatment, or on the prevention or diagnosis using the medicinal product. The advertisement must not contain misleading information. The advertisement must not contain offers and/or promises of a gift and/or another material or nonmaterial benefit.
A healthcare professional or a person claiming to be a healthcare professionals may not engage in direct or indirect advertising of medicinal products in the printor electronic media, as well as on the internet.
The MPHMA specifies that only non- prescription drugs (OTCs) may be subject to promotion and advertising to the general public.
The Ordinance provides further details with respect to the content of over- the-counter advertising to the general public.
As a general statement, the advertising of medicinal products intended for the general public including also the advertising or on the windows display of pharmacies and drug stores, must be clearly identifiable as advertising of a medicinal product.
The Ordinance provides a list of forbidden content when advertising to the general public, including advertising creating the impression that the use of the medicinal product excludes the necessity of medical consultation or surgical intervention; or implies that the effects of the medicinal product are guaranteed without side effects, or that human health can be improved upon using the medicinal product. This list is not exhaustive.
The Ordinance also prohibits advertising of narcotics and the provision of samples of medicinal products to the general public.
According to National Ethical Standards for Advertising and Commercial Communication in Bulgaria, adopted by the Association “National Council for Self-Regulation”, medicines, must not be shown as accessible for children without parental supervision. According to the Ethical Standards commercial communications must not show children using such materials.
5.2 Medical devices
According to Regulations 745 and 746, in the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:
- Ascribing functions and properties to the device which the device does not have;
- Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
- Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
- Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Only CE marked medical devices may be promoted and placed on the market. Non-CE marked medical devices may be exhibited at trade fair and exhibitions provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
No national specific restrictions applicable to the advertising of medical devices exist apart from the general rules applicable to advertising in general.
In addition to that, according to the Code of Ethics of the healthcare practitioners, any signs or symbols on the plates in front of doctors’ offices, on letterheads and prescriptions, in phonebooks and other materials must not have the characteristics of an advertising.
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