POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The following products are approved for sale without a marketing authorisation: • magistral formulas; • official formulas; • radiopharmaceutical products prepared at the time of use in authorised medical entities, from author- ised generators, kits, radionuclides and precursors, in accordance with the manufacturer’s instructions, and radionuclides in the form of sealed radiation sources; • blood and plasma in full composition or blood cells of human or animal origin, excluding plasma pro- cessed by an industrial process; • pharmaceutical raw materials not intended for the preparation of prescription and pharmacy pharma- ceuticals; • immunological veterinary medicinal products made from pathogens or antigens derived from animals on a farm and intended for the treatment of animals on that farm; and • advanced therapy medicinal products (hospital exceptions). Polish law does not operate a single, standalone “compassionate use programme” label compara- ble to some jurisdictions. However, patient access to non-authorised medicines may occur via specific legal mechanisms – in particular, named-patient or target import ( import docelowy ) under Article 4 of the Pharmaceutical Law Act and, separately from authori- sation, certain emergency access/reimbursement pathways. Any medicinal products imported from abroad are allowed to be marketed without the need for authorisation if their use is necessary to save the life or health of a patient, provided that the medicinal product is authorised in the country from which it is imported and has a current marketing authorisation. Article 4 also provides for temporary placing on the market in exceptional emergency situations (eg, dis- aster/serious threat), subject to the statutory prereq- uisites. In accordance with Article 59 (1) of the MDR, the competent authority (ie, the President of the URPL in Poland) may, upon receiving a duly justified request,
• Proceedings for the issuance of a marketing authorisation for a medicinal product should be completed within no more than 210 days of the application being submitted. • If it is necessary to supplement the documents or to submit explanations, the President of the URPL shall issue a decision to suspend the deadline. Fees for marketing authorisation applications and post-authorisation procedures are set in secondary legislation and depend on the procedure route and product type. In practice, the amounts can range up to tens of thousands of złoty for some cases. The pro- cedure for a variation of a marketing authorisation is governed by Commission Regulation No 1234/2008 of 24 November 2008 and the Pharmaceutical Law Act (Article 31). The change procedure depends on the type of change. Changes are made by the President of the URPL at the request of the marketing authori- sation holder. If there is a change of marketing authorisation holder, the President of the URPL shall issue a new authori- sation on the basis of the application of the person assuming the rights and obligations of the existing marketing authorisation holder. The decision issued in favour of the new marketing authorisation holder shall come into force no later than six months after it is issued. The requirements that have to be satisfied before medical devices can be placed on the market are con- tained primarily in the MDR and the IVDR. In addition, Polish national requirements apply under the Medical Devices Act and URPL guidance. Local registration procedures must be carried out by manufacturers of custom-made medical devices, their authorised representatives as well as importers, who are obliged to submit an application for registra- tion of the conducted activity to the President of the URPL before placing that device on the market. The obligation concerns entities that have their place of residence or registered office within the territory of Poland.
240 CHAMBERS.COM
Powered by FlippingBook