POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
The distributor must first obtain an access code and password. After obtaining access, the distributor must enter, among other data, the Basic UDI-DI and the manufacturer’s details, and must register each device/ system/procedure pack brought into Poland for the first time within seven days from bringing the first device into Poland. Registration of distributors in the list has been mandatory since 1 July 2024. 6.2 Different Classifications Applicable to Pharmaceuticals The Pharmaceutical Law Act divides pharmaceuticals into the following categories: • available without prescription (over-the-counter, or OTC); • available on prescription only (Rp); • available on prescription only, for restricted use (Rpz); • available on prescription only, containing narcotic drugs or psychotropic substances specified in separate regulations (Rpw); and • for hospital use only (Lz). 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies In accordance with the Pharmaceutical Law Act, the import of medicinal products takes place only if such products are brought in from a territory outside the European Economic Area (EEA). If a medicinal prod- uct is delivered to Poland from another country within the EEA, such delivery is deemed to be wholesale of medicinal products, rather than being qualified as an import. Export and parallel import are also classified as instances of wholesale. In addition, for certain products facing potential short- ages in Poland (as listed by the Minister of Health), a specific export/sale outside Poland notification regime applies. The business entity must report the intent to export or sell outside Poland, and the Chief Pharma- ceutical Inspector may object within 30 days. If there is no objection, the entity must still report the fact of export/sale within seven days.
Similarly, the Medical Devices Act defines an importer by reference to the MDR and the IVDR, under which the importer is an entity that places a medical device from a third country on the EU market. Articles 38 to 51a of the Pharmaceutical Law Act govern the import of medicinal products. The import of medical devices is regulated primarily in the MDR and the IVDR, although important provisions might be found in the Medical Devices Act as well. The main obligations for an importer are contained in Articles 13 and 16 of these two Regulations. For medicinal products (including investigational medicinal products), the GIF issues manufacturing/ import authorisations and supervises compliance, including GMP inspections. For medical devices, the President of the URPL acts as the competent author- ity for market surveillance/enforcement under the Medical Devices Act/MDR/IVDR. Where an importer is established in Poland, registration steps (including obtaining a Polish-issued SRN based on EUDAMED actor registration) are handled with the URPL. 7.2 Importer of Record of Pharmaceuticals and Medical Devices For medicinal products, the importer of record (for commercial import from outside the EEA) must in practice be an entity holding a valid authorisation for the import of medicinal products (as part of manufac- turing/import authorisation), issued by the Chief Phar- maceutical Inspector. This also applies to the import of investigational medicinal products. Separate Pol- ish rules on incompatibilities apply at the retail level. A pharmacy licence is refused if the applicant holds (or has applied for) an authorisation to manufacture or import medicinal products, or conducts wholesale distribution, among other grounds. Any person, natural or legal, can act as an importer of record of pharmaceuticals. However, an importer of pharmaceuticals cannot apply for a licence to run a pharmacy. Any person, natural or legal, whose place of residence or headquarters, respectively, is in the EU can act as an importer of record of medical devices. If the importer is established in Poland, Polish law requires
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