SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
1.4 Obligations to Notify Regulatory Authorities
effects that are clearly documented in the product information and quantified in the technical docu - mentation, and are subject to trend reporting; and • any field safety corrective action in respect of devices made available on the EU market, includ - ing any field safety corrective action undertaken in a third country in relation to a device that is also legally made available on the EU market, if the reason for the field safety corrective action is not limited to the device made available in the third country. In addition, healthcare professionals and authorities who, in the course of their activity, become aware of a serious incident must also notify it to the AEMPS, through the electronic site enabled for this purpose, and the AEMPS will transfer it to the manufacturer of the affected product. Patients and users are also allowed to notify serious incidents to the AEMPS using the electronic procedure enabled for this pur - pose, without prejudice to the notification they may have made to the manufacturer, another economic agent or the healthcare professional. Food and Nutritional Products In accordance with Article 19 of Regulation No 178/2002, if a food business operator considers or has reasons to believe that any of the food that it has imported, produced, processed, manufactured or dis - tributed does not meet the safety requirements, it shall immediately withdraw that food from the market when the food is no longer subject to its immediate control, and shall inform the competent authorities thereof. If the product has reached consumers, the operator will effectively and accurately inform consumers of the reasons for its withdrawal. Moreover, if the compe - tent authorities deem it necessary, the operator will recover the products that have already been supplied to consumers when other measures are not sufficient to achieve a high level of health protection. 1.5 Penalties for Breach of Product Safety Obligations The intentional or negligent breach of product safe - ty obligations may be subject to administrative and criminal sanctions. Any person responsible for such a breach can also be liable for damages.
The trigger for notification to authorities in respect of product safety issues may vary depending on the type of product at issue and the applicable regulations. Medicinal Products For instance, regarding medicinal products, applica - ble regulations establish that the holder of a marketing authorisation is obliged to: • comply with its pharmacovigilance obligations; • observe the conditions under which the marketing authorisation was granted, in addition to the gen - eral obligations established in the legislation; • submit periodic safety reports established by regu - lation, in order to keep the safety file updated; • make the results of clinical trials public, regardless of outcome of their conclusions are favourable or not; and • collaborate in the control programmes, guarantee the suitability of the products on the market and report any possible withdrawal of batches from the market, and notify the AEMPS, the autonomous regions and the authorities of all countries where it has been distributed, with the appropriate speed for each case and stating the reasons and any action undertaken to withdraw a batch from the market. Without prejudice to their own responsibility, all authorities and health professionals, as well as phar - maceutical companies and distribution entities, are obliged to collaborate diligently in the dissemination of knowledge of the safety of the product. Likewise, health professionals, pharmaceutical companies and distribution entities are obliged to notify any anomalies of which they have knowledge to the health authori - ties. Medical Devices Manufacturers of medical devices made available on the EU market shall report the following to the relevant competent authorities, in accordance with provisions of Regulation (EU) 2017/745: • any serious incident involving devices made avail - able on the EU market, except expected side
241 CHAMBERS.COM
Powered by FlippingBook