In April, Royal Decree-Law 7 of 27 April 2021 was passed. It introduced major amendments to Royal Legislative Decree 1 of 16 November 2007, approving the revised text of the General Consumer and User Protection Act and other supplementary acts, which we analysed in our May newsletter.
The Spanish association of pharmaceutical companies (“Farmaindustria”) has updated the Code of Good Practice for the Pharmaceutical Industry (“Code”), which came into force last 1 January 2021. This amendment is mainly aimed to introduce to section 14.2 of the Code a new definition and regulation for non-interventional studies in accordance with the provisions of the new Royal Decree 957/2020, of 3 November, which regulates non-interventional studies with medicines for human use (“RD 957/2020”). The RD 957/2020 came into force last 2 January 2021.