POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
prior registration in the relevant MDR/IVDR electronic system (EUDAMED), as well as an application to the President of the URPL for the issuance of a Single Registration Number (SRN). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The importation of medicines requires a licence from the Chief Pharmaceutical Inspector, even if the phar- maceuticals are only intended to be imported for the purpose of further exporting them outside the EEA. It is likewise compulsory for the import of investigational medicinal products, for example. An application for a licence should specify which medicinal products are going to be imported. An importer can only import medicines that are covered by a licence. The Pharmaceutical Law Act also allows imports on the basis of an agreement with another importer. Information on importers is publicly available in the Register of Manufacturers and Importers of Medici- nal Products provided by the Chief Pharmaceutical Inspector. Licensed importers of a medicinal product are not exempt from civil or criminal liability in relation to the use of the medicinal product. The import of medical devices will require registra- tion with EUDAMED prior to a device being placed on the market. After filing with the register, the importer should apply to the President of the URPL for an SRN. EUDAMED’s first four modules (including actor registration and UDI/devices registration) become mandatory EU-wide from 28 May 2026, following the Commission’s functionality notice and a six-month transition period. Custom-made devices are generally excluded from the UDI/devices registration module, but economic operator (actor) registration/SRN obli- gations may still apply, depending on the operator’s role. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Parallel import is allowed (it is an instance of whole- sale trade) as required by EU law, especially the
standards related to the single market. However, this requires a licence for a particular medicinal product to be obtained from the President of the URPL. The licence is valid for five years, although it is possible to extend it for a further five years. In order for the parallel import of the medicinal product to be allowed, the medicines in question have to have: • the same active substances; • at least the same indications up to level 3 of the Anatomical Therapeutic Chemical (ATC) code; • the same strength; • the same route of administration; and • the same form or a similar form that does not result in therapeutic differences. The medicinal product subject to parallel import has to be properly repackaged in order to satisfy all the demands of the Pharmaceutical Law Act. Generally, if such repackaging is necessary, it is a legal require- ment and the trade mark holder cannot object to it. This should be read in line with EU trade mark exhaus- tion/repackaging principles. Repackaging is permis- sible where necessary to market the product in the importing member state and where the established conditions protecting the trade mark holder’s legiti- mate interests are met (eg, no adverse effect on prod- uct condition, proper presentation, and prior notice). For medical devices, non-tariff requirements are driven by MDR/IVDR compliance (conformity assessment/ CE marking, documentation, labelling/IFU require- ments, etc), while at the border importers established in Poland may also need to provide specified compli- ance documents in customs procedures, as required by Polish Medical Devices Act provisions linked to the EU Customs Code. 7.5 Trade Blocs and Free Trade Agreements Poland is a member state of the EU and thereby is part of the European single market comprised of all EU member states and three countries of the European Free Trade Association (EFTA) that chose to be part of the EEA: Iceland, Liechtenstein and Norway. Poland is also a member of the EU Customs Union. The EU itself is a party to an array of free trade agreements with third countries, which thus have an impact on Poland.
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