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New ÚST-27 and rules for advertising of pharmaceitals in the Czech Republic

We would like to inform you that effective January 1, 2025, the State Institute for Drug Control (“SÚKL”) has issued a new version of the UST-27 guideline (“guideline”). For ease of reference, we reviewed the guideline regarding changes, and we attach both the full version of the guideline but also a summary for you.

The full text is also available here (in Czech only): UST-27 version 4.

In addition to the changes of a formal nature, the guideline in particular clarifies the following:

1. Clarification of what is not considered advertising

In addition to the exclusions explicitly listed in Article 5(2) of the Act on Regulation of Advertising, SÚKL further specifies that the following are not considered advertising:

·         information on the availability of medicinal products without advertising elements, 

·         information on the interruption or termination of the supply of medicinal products on the market without advertising elements, 

·         information on the resumption of supply of medicinal products on the market without advertising elements, 

·         information on the withdrawal of batches of medicinal products without advertising features, 

·         approved educational materials for healthcare professionals and patients published on the SÚKL website,

·         information on health, the existence of certain diseases and their nature, and motivating the general public to seek diagnostic prevention or lifestyle changes or to seek a healthcare professional, 

·         materials addressed to patients who have been prescribed a specific therapy, informing about a specific medicinal product, provided that they inform about it objectively and in accordance with the SPC and that they are intended to be given to the patient by the doctor after he has given the patient oral instructions as part of the prescription education, 

·         meetings organised by patient organisations, with the presence of an expert guarantor, at which information on prescription-only medicines is provided only in accordance with the SPC and the guarantor verifies that the patients present have correctly understood the messages conveyed; only patients who have already been prescribed adequate treatment for the diagnosis in question and have therefore already been prescribed medicines may participate in such meetings, 

·         ensuring the participation of members of patient organisations in the program of events held for professional or scientific purposes, with the exception of promotional symposia of pharmaceutical companies, 

·         information provided as part of the recruitment of clinical trial subjects, unless it contains the prospective brand name of the medicinal product being evaluated, 

·         information provided by patient organisations, which complies with Section 5(2) of the Act on Advertising Regulation. 

2. Specification of means of communication intended for professionals

Professional journals in particular are considered to be communication means for professionals and are considered in a broader context, not just one issue or part of an issue (e.g. an annex, a column), and the method of distribution is also taken into account, i.e. whether such printed media are normally available to the public or whether their availability is restricted in some way (e.g. only to subscribers who are verified as professionals).

Advertisements for medicinal products intended primarily for professionals may also be disseminated in professional non-periodicals aimed at the education of professionals, including textbooks intended for the study of medicine. 

However, popular science publications aimed at the general public are not considered to be professional publications in which advertising of medicinal products to professionals could be placed.

3. Clarification of SPC compliance requirements

The SPC specifies that the advertisement must contain essential information according to the current SPC, including the date of its approval at first registration or its last revision.

4. Form of submission of the SPC

The sales representative may provide the visiting professional with the SPC in one of the following forms:

·         in printed form, 

·         in the form of a QR code, 

·         a link to the website where the valid SPC is located.

In case the expert requests only a printed form of the SPC, the sales representative is obliged to provide it to her/him. 

Similarly, the delivery of the SPC in the form of a QR code or a link to a website may be used when the expert visits the pharmaceutical company’s advertising stand at a congress or other meeting with the participation of experts.

Should you have any questions or comments, we remain at your disposal. 

Mgr. Igor Pieš partner

igor@kastnerpies.cz