INNsight article by Urszula Kalata Gryko, July 2014

Liability for medicinal product advertisements may be borne by a third party in case such person does not represent the MAH (Marketing Authorization Holder). A decision of the Polish Main Pharmaceutical Inspector dated February 19, 2014, case files no. GIF-P-R-450/42-12/JD/13, reasserts the above. In its decision, the Main Pharmaceutical Inspector (“MFI”) ordered the advertisement agency to immediately cease the airing of a commercial which mentioned the names of medicinal products. MFI reasoned its decision on the basis that the advertisement agency used the names of the medicinal products several times during a short film presented, in MFI’s opinion, publically during one of its meetings.


A decision of the Polish Main Pharmaceutical Inspector dated February 19, 2014, case files no. GIF-P-R-450/42-12/JD/13, reasserts the above. In its decision, the Main Pharmaceutical Inspector (“MFI”) ordered the advertisement agency to immediately cease the airing of a commercial which mentioned the names of medicinal products. MFI reasoned its decision on the basis that the advertisement agency used the names of the medicinal products several times during a short film presented, in MFI’s opinion, publically during one of its meetings.

MFI took the view that the advertisement agency had undertaken action which met the definition of ‘medicinal products advertisement’ according to Article 52 of the Pharmaceutical Act dated September 6, 2001 (unified text Journal of Laws 2008, No. 45, item 271 as amended) (“Pharmaceutical Act”). Subject to this regulation, any activity which consists of informing or encouraging the use of medicinal products, with the intention of increasing the number of prescriptions, delivery, sale or consumption of medicinal products, shall constitute a medicinal product advertisement.

The regulations pertaining to medicinal products advertisements, emanating from the Pharmaceutical Act, provide limitations as to the execution of advertisement activities of prescribed medicines to the broad public. In its decision, the MFI, through its analysis as to whether the commercial infringed regulations as regards who it was directed to, also observed that the advertisement was carried out by an unauthorized entity.

Without Knowledge and Consent

TMFI’s decision stipulated that the advertisement agency undertook actions which were not ordered by the relevant MAHs, and therefore without their knowledge and consent. According to Article 60 section 1 of the Pharmaceutical Act, medicinal products advertisements may be conducted solely by an MAH or on its behalf. The MAH is the entity that obtained express authorization to market a medicinal product. Usually, an MAH is a direct producer of the medicinal product or an entity within the producer’s group. The objective of the abovementioned regulation was to limit the scope of entities which would conduct medicinal product advertisement campaigns to entities acting on behalf of the MAH, which is liability for the medicinal products that are available in the open market.

Whilst an advertisement cannot be conducted without the express authority of an MAH, this does not mean that the activity itself cannot be described as a medicinal product advertisement. In fact, to the contrary, if the information published or aired by a given entity (advertisement agency, publishing house, Internet sites) fulfills the features of a medicinal product advertisement in line with the abovementioned regulations, the material may be considered as a forbidden, non-authorized advertisement. In order to establish whether given material constitutes a medicinal product advertisement, the features of that material and the information provided must be taken under consideration. This refers to, in particular, the use of evaluative statements, inductive statements or the use of advertisement statements which were previously not challenged by the authorities. Should the claims incorporated into the material contain language which is mandatory for medicinal products advertisements, the material may also be construed as a medicinal product advertisement in itself. This especially relates to the use of a legal warning which medicinal product advertisements require. In a decision dated September 4, 2009, case files no. GIF-P-R-450-81-4/JD/09, MFI declared that the very fact of publishing this legal warning in the press on material concerning a medicinal product meant that the material would be construed as a medicinal product advertisement.

In view that medicinal products can only be advertised by pre-determined entities, the publication of such an advertisement without MAH’s consent breaches the Pharmaceutical Act.

Correct but inconsistent

It should be noted that it is insignificant as to whether the advertisement fulfills the regulations of the Pharmaceutical Act as well as executive regulations with respect to the content of the advertisement, i.e. as to whether all mandatory information has been included. Even if a commercial is correct in that scope, it may still be considered to infringe the law, if the advertisement has been undertaken without the consent of the MAH.

Advertising or information agencies that conduct advertising activities, not only in the scope of medicinal products advertisements, but also in life-style or health issues, should consider whether the material directed to recipients fulfills the features of a medicinal product advertisement, and if so, whether such information is also consistent with formal requirements, i.e. whether or not consent has been obtained from a relevant, authorized entity.


Furthermore, with regard to medicinal products advertisements, MFI is entitled to initiate and engage in relevant administrative proceedings, including having the entitlement to demand explanations or information from the entity that conducts such activity without the consent of an MAH.

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Urszula Kalata Gryko
July 2014

u.kalata-gryko@kochanski.pl