In July 2013, the Spanish Congress approved Law 10\/2013. This Law implemented Directive 2010\/84\/EU on pharmacovigilance\u00a0and 2011\/62\/EU on the the prevention of the entry into the legal supply chain of falsified medicinal products. Moreover, Law 10\/2013 modified\u00a0various aspects of Law 29\/2006 on guarantees and rational use of medicinal products and medical devices.<\/p>\n
The amendment of Law 29\/2006 affected issues of great importance: among others, new rules were adopted on pricing and financing of\u00a0medicines, on special products addressed to individual patients, on the therapeutic positioning of a product and its valid therapeutic alternatives;\u00a0on substitution of medicines when dispensed at a pharmacy, reference pricing, legal regime of bio similar products, information systems\u00a0and advertising.<\/p>\n
In this work, the author goes through some of these novelties and analyzes them taking also into account the latest regulatory developments\u00a0and the importance of working on and approving a consolidated version of Law 29\/2006, as foreseen by the Fourth Final Provision of Law\u00a010\/2013.<\/p>\n","protected":false},"excerpt":{"rendered":"
In July 2013, the Spanish Congress approved Law 10\/2013. This Law implemented Directive 2010\/84\/EU on pharmacovigilance\u00a0and 2011\/62\/EU on the the prevention of the entry into the legal supply chain of falsified medicinal products. Moreover, Law 10\/2013 modified\u00a0various aspects of Law 29\/2006 on guarantees and rational use of medicinal products and medical devices. The amendment of… <\/p>\n