POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
The President of the URPL can suspend a market- ing authorisation when the circumstances described above do not pose a direct threat to public health. The marketing authorisation expires if the market- ing authorisation holder does not actually place the medicinal product on the market within three years of receiving the authorisation. The “sunset clause” also applies where the product is not placed on the market for three consecutive years after having ini- tially been placed on the market. In both cases, the authorisation expires by operation of law, subject to a possible URPL decision (on request) that it does not expire, where justified by public health or exceptional circumstances. In general, there is no “marketing authorisation” for medical devices. Placing on the market is based on compliance with MDR/IVDR (including conformity assessment, CE marking where required, and post- market obligations), supplemented by Polish require- ments under the Medical Devices Act, including reg- istration obligations in EUDAMED and the requirement for distributors to register with the list maintained by the President of the URPL. However, the following are prohibited: • placing on the market and putting into service/ using a medical device whose expiry date or date of safe use specified by the manufacturer has passed (eg, the shelf life date indicated on the packaging or in the instructions for use); • placing on the market a medical device whose certificate of conformity (issued by a notified body) has expired, been withdrawn or been suspended; • making available to laypersons (for self-use) most in vitro diagnostic (IVD) devices other than devices for self-testing, sample containers or general labo- ratory products; • making available to laypersons IVD devices not intended for self-testing (including most devices intended for near-patient/professional use), unless they meet the IVDR requirements applicable to self-testing devices; • placing on the market a product that was not originally a medical device under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), but that has been modified by an entity
other than the original manufacturer in such a way that its intended purpose and mode of action now meet the definition of a medical device or IVD, unless that entity places it on the market under its own name, registered trade name or trade mark; and • placing on the market in the territory of Poland medical devices, systems or procedure packs that are not intended for use in that territory (eg, nation- al versions with instructions for use only in another language or with a different intended purpose). Breach of the above prohibitions may result in the President of the URPL issuing an administrative deci- sion ordering the withdrawal from the market or with- drawal from use of the medical devices, products, systems or procedure packs concerned, where this is justified by the need to protect public health or patient safety. An administrative fine of up to PLN250,000 may also be imposed. In addition, the Medical Devices Act provides for a system of administrative fines that, depending on the infringement, may reach up to PLN5 million for misleading information contrary to MDR/IVDR, for example, or up to PLN2 million for certain advertising infringements. Other infringements carry lower (but still material) penalty caps. 3.4 Procedure for Obtaining a Marketing Authorisation The national procedure for obtaining a marketing authorisation is as follows. • The applicant should submit an application for a marketing authorisation for the medicinal product to the President of the URPL. • The President of the URPL formally verifies the application and attached documentation. • If formal deficiencies are found, the President of the URPL calls for the application to be supple- mented within at least seven days, under pain of leaving the application unprocessed. • If there are substantive comments on the submit- ted documentation, the President of the URPL calls on the applicant to submit supplements and clarifications.
239 CHAMBERS.COM
Powered by FlippingBook