SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
ried out under the exclusive responsibility of the physician and requires prior informed consent from the patient or their legal representative, a clinical report justifying the need for the treat- ment, approval from the healthcare centre where it will be administered and authorisation from the AEMPS. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Medicinal Products Royal Decree 577/2013 imposes the following main pharmacovigilance obligations on MAHs: • respect the good practices on pharmacovigi- lance published by the AEMPS; • have an adequate pharmacovigilance system; • have a suitably qualified person responsible for pharmacovigilance in both the EU and Spain; • submit periodic safety reports to the EMA; • have a risk management system for each medicinal product; • notify and record suspected adverse reac- tions; • monitor scientific literature worldwide; • carry out post-authorisation studies of effi- cacy and safety; and • perform a continuous evaluation of the risk- benefit parameters of the medicinal product. The MAH shall conduct the post-authorisation efficacy studies required by member states or the European Commission in the following cir- cumstances: • as a condition of the MA, where questions about the efficacy of the medicinal product arise that can only be resolved after the prod- uct has been placed on the market; and
• subsequent to the granting of an MA, where knowledge of the disease or clinical method- ology indicates that previous assessments of efficacy may need to be significantly revised. Products subject to additional monitoring requirements must include a black inverted tri- angle in their package leaflet and data sheet, accompanied by the sentence “this medicinal product is subject to additional monitoring” . Medical Devices Manufacturers, authorised representatives and importers or distributors of medical devices must notify the AEMPS of: • any malfunction or alteration of the charac- teristics of the device, as well as any inad- equacy in the labelling or instructions for use that could lead to death or serious damage to health; and • any reason of a technical or health-related nature linked to the characteristics or perfor- mance of a device that has led the manufac- turer to take systematic action on devices of the same type. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Medicinal Products Royal Decree 1345/2007 establishes the confi- dentiality/transparency regime that the AEMPS must follow in MA procedures for new medicinal products. Article 15 of Royal Decree 1345/2007 guarantees the absolute confidentiality of MA applications and the expert reports attached to such applications. Royal Decree 1345/2007 also requires that the AEMPS must have a public database with information on authorised medicinal products
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