Polish inspectorate rules pharma wholesalers can store commercial medicinal samples

Available languages: PL

Poland’s Chief Pharmaceutical Inspectorate (Główny Inspektorat Farmaceutyczny or GIF) published a decision on its website in June 2024 that pharmaceutical wholesalers can legally store free commercial samples of medicinal products. The question of where and under what conditions samples can be stored had not been specifically addressed in the past, raising questions that the GIF’s recent ruling has finally put to rest. 

The decision was issued in response to an application for an individual ruling. The applicant asked whether a party licensed as a pharmaceutical wholesaler may store free samples of medicinal products belonging to a marketing authorisation holder. The GIF responded that it can and cited the fact that the definition of wholesaling covers a broad range of activities, including any activity involving, without limitation, the storage of medicinal products. Furthermore, the specific categories of activities that are explicitly excluded from wholesaling do not include the advertising of medicinal products, including the provision of their samples. Thus, the GIF concluded that the storage of free samples by pharmaceutical wholesalers falls within the broad definition of wholesaling and is permitted, subject to the applicable requirements. 

At the same time, the GIF emphasised that importing samples from abroad falls outside the realm of trading (and wholesaling). The GIF also pointed out that storing free samples differs from distributing them. The distribution of free samples constitutes a type of advertising activity and falls within the exclusive domain of the marketing authorisation holder. The storage of samples, however, concerns the storage of a specific and appropriately labelled medicinal products. Hence, storing samples (even for advertising purposes) that belong to the marketing authorisation holder does not constitute advertising. Advertising occurs when samples are delivered, or other activities defined in the advertising legislation are conducted. As a result, the GIF sees no reason why a pharmaceutical wholesaler should not provide the service of storing free samples for a marketing authorisation holder who owns them. When doing so, samples must be appropriately labelled in accordance with statutory requirements and meet packaging-size regulations. In addition, they must be distinguishable from “regular” medicinal products. 

This is necessary because products must be clearly defined preventing the risk of illegal advertising or illegal trading of medicinal products. This decision has eliminated earlier doubts that previously appeared in trading practice, and will expedite the ability of marketing authorisation holders to store samples for marketing purposes. 

For more information on how this decision may impact your Poland-based business, contact your CMS client partner or these CMS experts.