SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
cases, the AEMPS, hospitals and regional authorities frequently put pressure on the company to supply the product free of charge. However, for the time being, Spanish law does not require that the supply be free of charge. Finally, off-label use of medicinal products is accept- ed when there are no authorised alternatives for the patient. Off-label use does not require AEMPS approval and may be accomplished under the health- care provider’s authority. Medical Devices Medical devices without CE marking, and those used outside of a clinical investigation or for conditions not included in the instructions for use, may be permitted under a compassionate use programme in accord- ance with the conditions established in Circular 7/2004 issued by the AEMPS. According to this Circular, the compassionate use of medical devices is carried 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 treatment, approval from the healthcare centre where it will be administered and authorisation from the AEMPS. 3.6 Ongoing Obligations Imposed by Marketing Authorisations Medicinal Products Royal Decree 577/2013 imposes the following main pharmacovigilance obligations on MAHs: • respect the good practices on pharmacovigilance 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 reactions; • monitor scientific literature worldwide; • carry out post-authorisation studies of efficacy and safety; and • perform a continuous evaluation of the risk-benefit parameters of the medicinal product.
The MAH shall conduct the post-authorisation effica- cy studies required by member states or the European Commission in the following circumstances: • as a condition of the MA, where questions about the efficacy of the medicinal product arise that can only be resolved after the product has been placed on the market; and • subsequent to the granting of an MA, where knowledge of the disease or clinical methodology indicates that previous assessments of efficacy may need to be significantly revised. Products subject to additional monitoring require- ments must include a black inverted triangle in their package leaflet and data sheet, accompanied by the sentence “this medicinal product is subject to addi- Manufacturers, authorised representatives and importers or distributors of medical devices must notify the AEMPS of: • any malfunction or alteration of the characteristics of the device, as well as any inadequacy 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 performance of a device that has led the manufacturer to take sys- tematic action on devices of the same type. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Medicinal Products Royal Decree 1345/2007 establishes the confidential- ity/transparency regime that the AEMPS must follow in MA procedures for new medicinal products. Article 15 of Royal Decree 1345/2007 guarantees the abso- lute 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 informa- tion on authorised medicinal products in Spain. This database must include the evaluation report issued by the AEMPS during the authorisation procedure tional monitoring”. Medical Devices
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