POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
June 1960. As a rule, there is always a legal remedy. Typically, an appeal against a first-instance adminis- trative decision is filed within 14 days. Decisions made by local branches of the authorities can be challenged by appealing to the main author- ity (eg, a decision of the Regional Pharmaceutical Inspector can be appealed to the Chief Pharmaceuti- cal Inspector), and the final decision is subject to judi- cial review by the administrative courts. In general, the administrative appeal is free of charge and not sub- ject to any specific formal requirements other than the explicit disagreement of the party. The judicial review is subject to a fee, which differs depending on the type of decision that is being questioned. A complaint to the voivodeship administrative court is generally filed within 30 days of service of the final decision. It is not possible to appeal against decisions made by the central authorities, such as the Chief Pharma- ceutical Inspector. The party may file a motion for the decision to be reconsidered or proceed directly to a judicial review by the administrative courts. 1.3 Categories of Pharmaceuticals and Medical Devices In principle, the regulations mentioned in 1.1 Legisla- tion and Regulation apply to all categories of medi- cines. However, certain categories are subject to addi- tional or stricter rules (eg, dispensing, advertising and controlled-substance restrictions). Medical devices and in vitro diagnostic medical devices are regulated separately at the level of EU law, but in national law they are regulated by a single statute. Within the MDR/IVDR framework, devices are risk-classified, and the class determines, among other matters, the conformity-assessment route (including whether a notified body must be involved) and certain post-market obligations.
el. Medicinal products are governed primarily by Reg- ulation 536/2014, while medical devices are covered by the MDR/IVDR framework (clinical investigations under the MDR and performance studies under the IVDR), supplemented by Polish implementing legisla- tion. On a national level, clinical trials of pharmaceu- ticals are regulated by the Clinical Trials of Medicinal Products for Human Use Act of 9 March 2023, while clinical investigations/performance studies relating to medical devices and in vitro diagnostic medical devic- es are regulated by the Medical Devices Act (Articles 31 to 47). 2.2 Securing Authorisation to Undertake a Clinical Trial The provisions of the Clinical Trials of Medicinal Prod- ucts for Human Use Act clarify the rules of proce- dure for issuing a clinical trial authorisation set forth in Regulation 536/2014. A clinical trial can be started after a decision from the President of the URPL to issue a clinical trial permit (subject to the possibility of “so-called” implied con- sent in cases specified by Regulation No 536/2014) has been obtained and a bioethical committee has issued a positive opinion on the study. The application for permission is submitted through the Clinical Trials Information System (CTIS). As a rule, it is possible to submit documentation in English or Polish (with the exception of certain elements which the law pro- vides must be in Polish). In practice, the CTIS dossier is typically prepared in English for the co-ordinated assessment, while participant-facing and local/site documents (informed consent, recruitment materials and certain contracts/insurance confirmations) are commonly required in Polish for the national/ethics assessment. The rules for the payment of the application fee are determined in Article 58 of the Act. The amount of the fee depends on the phase of the clinical trial. In the case of a commercial phase I-III clinical trial, the fee is PLN30,000 when Poland acts as the report- ing member state and PLN25,000 when Poland does not act as the reporting member state (with separate amounts provided for Phase IV trials and certain other application types). Proof of payment must be attached in CTIS.
2. Clinical Trials 2.1 Regulation of Clinical Trials
Clinical trials of medicinal products and studies involv- ing medical devices are regulated under different EU frameworks, although both are harmonised at EU lev-
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