SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
Faus Moliner Abogados Rambla de Catalunya 135 08008 Barcelona Spain Tel: +34 93 292 21 00 Email: bcn@faus-moliner.com Web: www.faus-moliner.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Key Legislation The following legislation governs medicinal products and medical devices in Spain. • General pharmaceutical legislation: (a) Law 14/1986 (the “General Law on Public Health” ) (b) Law 16/2003, of 28 May, on the cohesion and quality of the National Health System; and (c) Royal Legislative Decree 1/2015, which approves the consolidated version of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices. • The authorisation, registration and distribution of medicinal products: (a) Royal Decree 1345/2007, which regulates the authorisation, registry and dispensa- tion conditions of medicinal products for human use prepared industrially for human use; (a) Royal Decree 477/2014, which regulates the authorisation of medicinal products
for advanced therapies not prepared industrially; (b) Royal Decree 824/2010 on pharmaceuti- cal companies, manufacturers of active ingredients, foreign trade of medicinal products and investigational medicinal products; (c) Royal Decree 1785/2000 on the intra- community trade of medicinal products for human use; and (d) Royal Decree 782/2013, which regulates the distribution of medicinal products. • Medical devices: (a) Royal Decree 192/2023, which regulates medical devices; (b) Royal Decree 1616/2009 on active implantable medical devices (partially repealed); and (c) Royal Decree 1662/2000 on in vitro diag- nostic medical devices. • Clinical studies, pharmacovigilance and access to medicinal products in special situ- ations: (a) Royal Decree 1090/2015, which regu- lates clinical trials, ethics committees for research on medicinal products and the Spanish registry for clinical trials; (b) Royal Decree 967/2020, which regulates observational studies of medicinal prod-
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