SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation 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 ap- proves 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 dispensation con- ditions of medicinal products for human use prepared industrially for human use; (b) Royal Decree 477/2014, which regulates the authorisation of medicinal products for ad- vanced therapies not prepared industrially; (c) Royal Decree 824/2010 on pharmaceutical companies, manufacturers of active ingredi- ents, foreign trade of medicinal products and investigational medicinal products; (d) Royal Decree 1785/2000 on the intra-commu- nity trade of medicinal products for human use; and (e) Royal Decree 782/2013, which regulates the distribution of medicinal products. • Medical devices: (a) Royal Decree 192/2023, which regulates medi- cal devices; (b) Royal Decree 942/2025 on in vitro diagnostic medical devices; (c) Royal Decree 1616/2009 on active implantable medical devices (partially repealed); and (d) Royal Decree 1662/2000 on in vitro diagnostic medical devices (partially repealed). • Clinical studies, pharmacovigilance and access to medicinal products in special situations: (a) Royal Decree 1090/2015, which regulates clini- cal trials, ethics committees for research on
medicinal products and the Spanish registry for clinical trials; (b) Royal Decree 967/2020, which regulates ob- servational studies of medicinal products for human use; (c) Royal Decree 577/2013, which regulates phar- macovigilance in relation to medicinal products for human use; (d) Law 14/2007 on biomedical research; and (e) Royal Decree 1015/2009 on access to medici- nal products in special situations. • Price, reimbursement and promotion: (a) Royal Decree 271/1990, which regulates the prices of medicinal products reimbursed by the National Health System; (b) Royal Decree 177/2014, which regulates the reference price system and homogeneous groups of medicinal products in the National Health System and information on the reim- bursement and prices of medicinal products and medical devices; (c) Royal Decree 823/2008, which establishes the margins, deductions and discounts corre- sponding to the distribution and dispensation of medicinal products for human use; (d) Royal Decree 90/2026, which regulates the procedure for selective financing of medical devices charged to the pharmaceutical benefits of the National Health System for non-hospital- ised patients and determining the margins cor- responding to their distribution and dispensing (effective 1 July 2026); (e) Royal Decree 1416/1994, which regulates the advertising of medicinal products, and provi- sions established in Articles 38–40 of Royal Decree 1594/2009, which regulates medical devices (partially repealed by Royal Decree 192/2023); and (f) Royal Decree 870/2013, which regulates online sales to the public of non-prescription medici- nal products. Regional authorities (Spain is divided into 17 autono- mous regions) may also enact and enforce regulations that are applicable at their level and within their scope of competence (eg, pharmacy offices or healthcare provision).
322 CHAMBERS.COM
Powered by FlippingBook