POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
allow the placing on the market or putting into ser- vice in the territory of the member state concerned of a specific device for which the relevant procedures referred to in the relevant provisions of the MDR have not been carried out, if the use of which is in the inter- est of public health or the safety or health of patients. 3.6 Ongoing Obligations Imposed by Marketing Authorisations The following obligations may be imposed in the mar- keting authorisation: • to take measures, within the framework of the risk management system for the use of the medicinal product, to ensure the safe use of the medicinal product; • to conduct post-authorisation safety studies; • to record or report adverse reactions; • to use an appropriate system for the supervision of the safe use of medicinal products; • to conduct post-authorisation efficacy stud- ies where doubts have arisen regarding certain aspects of this medicinal product’s efficacy that can only be clarified after it is placed on the mar- ket; and • to provide information on the safety and efficacy of the medicinal product in question resulting from scientific and technical progress and the expansion of knowledge about that medicinal product. In addition, as a matter of routine EU/Polish pharma- covigilance requirements, the marketing authorisation holder must operate a pharmacovigilance system (including a qualified person responsible for pharma- covigilance, appropriate reporting, and compliance with risk management obligations), and submit peri- odic safety documentation where applicable. With regard to medical devices, each manufacturer analyses all complaints about the device, as well as cases of error in use and misuse. The analysis depends on risk management, ergonomics, design validation, and corrective and preventative actions. The manufacturer shall make the results of the anal- ysis available at the request of the President of the URPL and the notified body involved in the conformity assessment of the device. The manufacturer assess- es the risks associated with the devices affected by
the medical incident and, based on this assessment, decides whether corrective actions are necessary and to what extent. The manufacturer shall describe the corrective action in the Field Safety Corrective Action Report. The corrective action must be communicated to customers via a Field Safety Notice. The manufacturer initiates an investigation into the reported medical incident and decides whether said incident meets the criteria for reporting to the Presi- dent of the URPL. This description should be read as part of the broader MDR/IVDR post-market sur- veillance and vigilance framework (including incident reporting and field safety corrective actions), supple- mented by Polish enforcement powers and adminis- trative penalties under the Medical Devices Act. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Third parties have access only to information on medicinal product authorisation published by the URPL (ie, the authorisation itself, the Summary of Product Characteristics, and the Patient Information Leaflet). As a rule, the URPL publishes the product information set (SmPC, PIL) for authorised products. Risk Management Plans are obligatory in the dossier, but they are not generally disclosed in full. Other documents are available on request but only to entities that can substantiate their legal interest (eg, violation of rights), and subject to the protection of proprietary information. There are no specific regu- lations allowing disclosure of the process of apply- ing for the marketing authorisation. Ending (ongoing) marketing authorisation procedures are not publicly transparent as to their file contents. In the case of medical devices, it is possible to obtain public information on information contained in safety notes and certificates of conformity, and on the issu- ance, amendment, supplementation, suspension and withdrawal of certificates of conformity.
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