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Who May Be Subject to Advertising Regulations in Poland?

Who May Be Subject to Advertising Regulations in Poland?

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As a rule, medical device advertising can be conducted by economic operators, i.e. manufacturers, distributors, authorized representatives and importers (Article 56 (1) of the Polish Medical Devices Act of 7 April 2022 (the MDA)). Other entities can conduct advertising only after approval of the advertisement in writing by the economic operators.

Which entities are authorized to advertise medical devices?

As a rule, medical device advertising can be conducted by economic operators, i.e. manufacturers, distributors, authorized representatives and importers (Article 56 (1) of the Polish Medical Devices Act of 7 April 2022 (the MDA)). Other entities can conduct advertising only after approval of the advertisement in writing by the economic operators.

Such approval may be in the form of a framework agreement and authorize advertising activities to be carried out during a certain period of time.

The Polish rules on medical device advertising will also apply to the advertising of business or professional activities (e.g. healthcare professionals or other professional users) in which a medical device is used to provide services, insofar as it concerns services provided with the use of the specific device in question.

Who is responsible for unlawful advertising?

According to the provisions of the MDA (Article 56(2)), the economic operator that conducts the advertising of medical devices is responsible for its compliance with the legal regulations.
However, sanctions for violations of the advertising rules can be imposed also on other entities, e.g. entities advertising medical devices without approval of the economic operators. As a result, any entity that conducts promotional activity (e.g. influencer, healthcare professional, person who runs a business where the device is used to provide services) may also be held liable for violating advertising restrictions.

Pursuant to the MDA (Article 103(2)) for non-compliance with advertising provisions the competent authorities may impose an administrative fine of up to PLN 2 million (approx. EUR 444,000) on anyone who conducts advertising regardless of its status. Thus, the procedures connected with the approval of a given advertisement by an economic operator and cooperation agreements will be crucial.

Obligation to store advertising templates and information about places where advertising was disseminated

The MDA imposes an obligation upon economic entities to store templates of all advertisements directed to the public and information about places where they were disseminated.
The storage obligation lasts for two years after the end of the year during which the advertisement was made available (Article 61 of the MDA). The economic operator is also obliged to make these documents available upon request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL).
Media service providers or publishers are obliged to keep names and addresses of businesses or individuals placing paid advertisements or announcements and any other material relating to the advertising of medical devices for a period of not less than one year and provide them to the President of the URPL upon request.

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal

 

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