SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
Furthermore, there is a self-regulatory framework established by trade associations (eg, Farmaindus- tria, Fenin and Aeseg) that enforce their own codes of practice. These codes of practice have a binding effect on their members and primarily govern adver- tising and interactions with healthcare organisations, healthcare professionals and patients’ organisations. Although adherence to these trade associations or their codes of practice is not mandatory, authorities often reference them as a reflection of the current social reality and take them into account in practice. Regulatory Authorities At the national level, the main regulatory authorities responsible for applying and enforcing regulations on medicinal products and medical devices are the Ministry of Health (MOH) and the Spanish Agency for Medicines and Medical Devices ( Agencia Española de Medicamentos y Productos Sanitarios AEMPS). Among other functions, the MOH is responsible for drafting and implementing the rules on pricing and reimbursement of medicinal products. The AEMPS is responsible for the issuance of marketing authorisa- tions (MAs) for medicinal products in Spain, which includes overseeing the authorisation process through national, mutual recognition and/or decentralised pro- cedures, amongst other matters. At the regional level, regional regulatory authorities enforce regulations in the aforementioned areas and enact rules within their scope of competence. Moreover, regions participate in the MOH’s commit- tee responsible for evaluating pricing and reimburse- ment applications for medicinal products. High-level co-ordination among all regional healthcare systems mainly occurs through the National Health Service (NHS) Interterritorial Council, which comprises the national Minister of Health and the 17 regional minis- ters of health. 1.2 Challenging Decisions of Regulatory Bodies Decisions of regulatory bodies may be challenged through both administrative appeal and judicial review. In some cases, the administrative appeal is mandatory, and it must be filed within one month from receiving notice of the decision.
After administrative proceedings, the interested party may go to court within two months of receiving notice of the decision; if no notice is received, the deadline is six months from the presumed rejection date. 1.3 Categories of Pharmaceuticals and Article 8.1 of Royal Legislative Decree 1/2015 distin- guishes between four types of medicinal products: • medicinal products for human and veterinary use that are industrially manufactured, or in the manu- facture of which an industrial process is involved; • magistral formulae; • official preparations; and Medical Devices Medicinal Products • special medicinal products (eg, vaccines and other biological medicinal products, advanced therapy medicinal products, radiopharmaceuticals, homeo- pathic medicinal products or medicinal gases). In relation to prescription and dispensing conditions, Royal Legislative Decree 1/2015 contemplates the same classification set forth in Article 70 of Directive 2001/83/EC. Medical Devices Medical devices are classified into four classes (III, IIb, IIa and I), as are in vitro diagnostic medical devices (A–D). Devices are ranked considering their level of invasiveness according to Regulation (EU) No 2017/745 on medical devices (MDR) and Regulation (EU) No 2017/746 on in vitro diagnostic medical devic- es (IVDR). Additionally, medical devices can be cat- egorised based on their intended purpose, following the classifications outlined in European regulations.
2. Clinical Trials 2.1 Regulation of Clinical Trials
In Spain, clinical trials with medicinal products are mainly regulated by Royal Legislative Decree 1/2015 and Royal Decree 1090/2015, whereas clinical inves- tigations with medical devices are governed by Royal Decree 192/2023.
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