SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions of regulatory bodies may be chal- lenged 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 interest- ed 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 Different Categories of Pharmaceuticals and Medical Devices Medicinal Products Article 8.1 of Royal Legislative Decree 1/2015 distinguishes between four types of medicinal products: • medicinal products for human and veterinary use that are industrially manufactured, or in the manufacture of which an industrial pro- cess is involved; • magistral formulae; • official preparations; and • special medicinal products (eg, vaccines and other biological medicinal products, advanced therapy medicinal products, radi- opharmaceuticals, homeopathic medicinal products or medicinal gases). In relation to prescription and dispensing condi- tions, Royal Legislative Decree 1/2015 contem- plates 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 medi-
cal devices (A, B, C and D). Devices are ranked considering their level of invasiveness accord- ing to Regulation (EU) No 2017/745 on medical devices and Regulation (EU) No 2017/746 on in vitro diagnostic medical devices. Additionally, medical devices can be categorised based on their intended purpose, following the classifica- tions 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 investigations with medical devices are governed by Royal Decree 192/2023. Moreover, the AEMPS has issued a document of instructions for the conduct of clinical trials with medicinal products in Spain and guidelines for conducting clinical investigations with medical devices, both of which are regularly updated. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Medicinal Products To initiate a clinical trial with medicinal products, the following will be required: • prior authorisation by the AEMPS, after a scientific and ethical evaluation in accordance with Regulation (EU) No 536/2014; • a favourable opinion issued by an ethics committee for research on medicinal prod- ucts ( comité de ética de la investigación con medicamentos CEIm) in Spain; and • a written agreement between the sponsor and the sites (clinical trial agreement; CTA).
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