POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
The manufacture of active pharmaceutical ingredients is subject to registration in the National Register of Manufacturers, Importers and Distributors of Active Pharmaceutical Ingredients. The manufacture of medical devices does not require a special licence. Medical device manufacturers must comply with MDR/IVDR requirements (including con- formity assessment where applicable), and the Pres- ident of the URPL acts primarily as the competent authority for market surveillance and enforcement under the Medical Devices Act/MDR/IVDR. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Undertaking the business of operating a pharmaceuti- cal wholesaler requires a licence from the Chief Phar- maceutical Inspector. Wholesale distribution covers activities such as the acquisition, storage, supply and export of medicinal products conducted in the course of wholesale distribution. An applicant for a licence should submit an application that includes: • a definition of the scope of the wholesale business; • the date on which the intended activity is to be undertaken; • the name of the person responsible for the opera- tion of the wholesale business; and • for pharmacists, the number of the professional licence, or the PESEL number in the case of other individuals (PESEL is the Polish acronym for “Uni- versal Electronic System for Registration of the Population”). The following items should be submitted with the application: • relevant declarations, including a declaration from the responsible person that they undertake this function as of the date the wholesale business started; • an opinion of the competent district pharmacy chamber regarding the responsible person, if they are a member of the pharmacy chamber;
• a description of the procedures for effective with- holding or withdrawal of the medicinal product or veterinary medicinal product from the market and from distributors; • a document confirming the legal title to the prem- ises intended for the business; • a technical description including illustrations con- cerning the premises intended for the business, prepared by an authorised person; and • an opinion on the suitability of the premises. The model of the application is specified in the Regu- lation of the Minister of Health dated 29 April 2019 on the model of the application for a licence to operate a pharmaceutical wholesaler. A wholesaler engaged in the wholesale distribution of medicines must: • have adequate facilities to carry out this activity; • employ a qualified person; • have a description of the procedure for the effec- tive cessation of distribution or withdrawal of a drug from the market; and • comply with the more specific obligations set forth in the Pharmaceutical Law Act. A wholesale licence is issued for an indefinite period of time, unless the applicant has applied for a fixed- term licence. The fee for granting a licence to operate a pharmaceutical wholesaler is PLN6,756 (approxi- mately EUR1,600). On 1 February 2026, GIF introduced a new online application for reporting and updating lists of trans- port means used by pharmaceutical wholesalers and by entities holding manufacturing or import authorisa- tions. The previous email channel was discontinued. In Poland, the list of distributors of medical devices is maintained by the President of the URPL. The registration obligation applies to entities that have their registered office or place of residence in the ter- ritory of the Republic of Poland and act as a distribu- tor (within the meaning of the MDR/IVDR) and make medical devices available on the Polish market.
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