SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
of its activity, must withdraw from the market, suspend marketing or recover from the con - sumer or user, through effective procedures, any product that does not meet the conditions and requirements of RLD 1/2007 or which, for any other reason, represents a foreseeable risk to personal health or safety on any other grounds. In addition, the competent authorities may adopt all measures as are necessary and proportionate to eliminate the risk, including direct interven - tion regarding the product and direct compul - sion of the entity involved. In these cases, all the expenses incurred will be charged to the involved entity whose conduct gave rise to such measures, irrespective of the sanctions that may be imposed, if any. The levying of such expenses and penalties may be carried out through the administrative enforcement procedure. Taking into account the nature and severity of the risks detected, public authorities may also inform affected consumers and users through the most appropriate means about the existing risks or irregularities, the affected product, the meas - ures adopted and the appropriate precautions, in order to protect themselves from the risk and obtain their collaboration in the elimination of its causes. 1.4 Obligations to Notify Regulatory Authorities 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, applicable regulations establish that the holder of a marketing authorisation is obliged to:
• comply with its pharmacovigilance obliga - tions; • observe the conditions under which the mar - keting authorisation was granted, in addition to the general obligations established in the legislation; • submit periodic safety reports established by regulation, in order to keep the safety file updated; • make the results of clinical trials public, regardless of the favourable (or not) outcome of their conclusions; and • collaborate in the control programmes, guar - antee 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 pharmaceutical companies and distribution enti - ties, are obliged to collaborate diligently in the dissemination of knowledge of the safety of the product. Likewise, health professionals, phar - maceutical companies and distribution entities are obliged to notify any anomalies of which they have knowledge to the health authorities. Medical Devices With regard to medical devices, manufacturers of devices made available on the Union market shall report to the relevant competent authori - ties, in accordance with provisions of Regulation (EU) 2017/745, the following: (a) any serious incident involving devices made available on the Union market,
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