POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
technical obligations for the maintenance of databas- es obtained in the course of a clinical trial. The provi- sions of Regulation No 536/2014 and the GDPR apply. In addition, the Polish Act of 10 May 2018 applies as the national GDPR-supplementing framework. In practice, trial stakeholders often maintain separate datasets/records for different purposes, including: • a database of clinical trial participants; • a database of research team members; and • a database of persons reporting adverse events. It is the responsibility of these entities to implement technical and organisational measures to protect the processed information and personal data from unau- thorised or unlawful access, disclosure, dissemina- tion, alteration, destruction or accidental loss, espe- cially in the case of processing involving transmission over a network. Depending on scale and risk, addi- tional GDPR obligations may be triggered. The provisions of the Pharmaceutical Law Act shall apply to a product that simultaneously meets the cri- teria of a medicinal product and the criteria of another type of product, in particular a dietary supplement, a cosmetic product or a medical device, as defined by separate regulations. In practice, the key substantive criterion for the medi- cine v medical device borderline is the product’s principal intended mode of action: pharmacological, immunological or metabolic action points towards a medicinal product, whereas a primarily physical/ mechanical mode of action points towards a medical device (with possible ancillary pharmacological action not changing the primary classification). 3. Marketing Authorisations 3.1 Product Classification Product qualification is carried out by the manufac- turer, in accordance with the statutory definitions of a medical device and pharmaceutical. Competent authorities may intervene if they consider the clas- sification incorrect, and they may require relabelling/ reclassification or take enforcement steps if a product
is placed on the market under an incorrect regulatory regime. However, the competences of authorities in this respect are not clearly defined or demarcated, which sometimes leads to delays in decisions. In bor- derline cases, classification practice is additionally shaped by EU-level guidance and case law. Depend- ing on the product type, the relevant Polish authorities may include the URPL for medicinal products/medical devices and sanitary authorities for food/dietary sup- plement aspects. 3.2 Marketing Authorisation for Biologic Medicinal Products Biological medicinal products may fall under different authorisation routes depending on their type. The EU centralised procedure (Regulation (EC) No 726/2004) is mandatory for specific categories, including prod- ucts derived from biotechnology, orphan medicines and certain other categories listed in EU rules. Where the centralised procedure applies, the marketing authorisation is granted at EU level (European Com- mission, after EMA assessment). 3.3 Period of Validity of Marketing Authorisations The marketing authorisation is issued for five years and may be renewed indefinitely, at the request of the marketing authorisation holder. An application for an extension should be made at least nine months before the expiry date of the authorisation. Following renewal, the authorisation is typically extended for an indefinite period; in exceptional cases (where justified by safety considerations), the authority may renew for a further five years. The President of the URPL is obliged to revoke a marketing authorisation if any of the circumstances described in Article 33 of the Pharmaceutical Law Act occur, including: • an unexpected serious adverse reaction; • the pharmaceutical does not have the declared therapeutic efficacy; or • the risk of using it is found to be disproportionate to its therapeutic effect.
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