Further to recent amendments to the Medicines and Sanitary Products Act (29/2006) (for further details please see "Medicines and Sanitary Products Act amended and new pharmacovigilance decree"), on September 17 2013 Royal Decree 686/2013, which modifies Royal Decree 1345/2007 (governing the process of authorising, registering and dispensing industrially manufactured human medicines), was published in the Official Bulletin.(1)
The recent changes referred to above amended the Medicines and Sanitary Products Act and the Pharmacovigilance Regulation (Royal Decree 1344/2007) through Act 10/2013 and Royal Decree 577/2013. These amendments mainly transposed into Spanish law EU Directive 2010/84/EC, which amended the pharmacovigilance provisions of EU Directive 2001/83/EC on the EU code relating to medicinal products for human use, and EU Directive 2011/62/EC, which amended EU Directive 2001/83/EC on the EU code relating to medicinal products for human use with regard to the prevention of the entry into the legal supply chain of falsified medicinal products.
Royal Decree 686/2013 aims to complete the transposition into Spanish law of these directives by introducing further post-authorisation obligations and more transparency and publicity requirements regarding the medicine itself. Furthermore, Royal Decree 686/2013 updates Royal Decree 1345/2007 in relation to:
- technical progress, by introducing further online uses; and
- the exclusion of advanced-therapy medicinal products from its scope of protection, by updating the list in light of EU Regulation 1394/2007 on advanced therapy medicinal products.
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