On July 25 2013 Act 10/2013, which amends the Medicines and Sanitary Products Act (29/2006) and other related acts, was published in the Official Bulletin. Shortly thereafter, on July 27 2013, Royal Decree 577/2013, relating to pharmacovigilance of medicinal products for human use, was published in the Official Bulletin.
The amendments focus on certain key areas.
Royal Decree 577/2013 transposes into Spanish law EU Directive 2010/84/EC, which amended the pharmacovigilance provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use. The transposition period for this directive expired on July 21 2012.
Other significant changes include:
- greater cooperation between the Medicines and Sanitary Products Agency and the EU institutions (particularly the European Commission);
- tightening of communications regarding the risks of medicines and updated information on medicines issued by laboratories and other parties;
- extension of information on side effects to citizens;(1)
- stronger controls for certain medicines; and
- increased transparency of medicines security by obliging the Medicines and Sanitary Products Agency to publish its decisions on pharmacovigilance (including the reasons for such decisions).
Falsified medicinal products
Act 10/2013 transposes into Spanish law EU Directive 2011/62/EC, which amended Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. The transposition period for this directive expired on January 2 2013.
The changes include stronger control over distribution channels and customs-free areas. A register of active ingredients manufacturers will also be established.
The Medicines and Sanitary Products Act has been updated in light of Directive 2009/53/EC, which amended Directives 2001/82/EC and 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. Directive 2009/53 had already been transposed by:
- Royal Decree 1091/2010, which modified Royal Decree 1345/2007, as regards the procedure to authorise, register and establish dispensation conditions for medicinal products for human use; and
- Royal Decree 1246/2008, as regards the procedure to authorise, register and establish dispensation conditions for veterinary medicinal products.
Cosmetics and personal care products
The definition of 'cosmetic products' has been updated in light of EU Regulation 1272/2008, which amended and repealed Directives 67/548/EEC and 1999/45/EC, and amended EU Regulation 907/2006. The term 'personal hygiene products' has further been replaced with the wider category of 'personal care products'. Both cosmetics and personal care products fall within the scope of application of the Medicines and Sanitary Products Act. The new amendments add a list of infringements regarding such products to the Medicines and Sanitary Products Act, which will be subject to the sanctions, preliminary injunctions and warranties envisaged in that act. The amendments further add a list of infringements regarding sanitary products ato the act; previously, these were set out in specific regulations.
The following exceptions have been introduced, among others:
- fees for the manufacture of medicines that have no market interest, but which have sanitary interests;
- activities regarding advanced therapies conducted by public entities integrated into the National Health System;
- a 95% reduction in fees for marketing authorisations of interest to the authorities; and
- a 70% reduction in fees for the evaluation of veterinary medicinal products for minor species.
Regarding the Price and Reimbursement System, Act 10/2013 clarifies the limitation of the obligation to substitute prescribed brand-name medicines with generics if the price of the generic is lower in the case of biological medicines financed by the National Health System. The clarification states that the substitution of prescribed brand-name medicines with biosimilars should observe the specific rules on substitution and interchangeability. This sounds logical, but clarification was required, as in practice the procedure was unclear to all parties involved.
Act 10/2013 repeals Article 102(2) of the Act on General Health, which referred to the requirement for a previous authorisation for the advertising of medicines and sanitary products, when such advertising is permitted. This repeal is based on the modification of Article 78 of the Medicines and Sanitary Products Act introduced by Act 10/2013 regarding the advertising of medicines. In particular, the modification implies the replacement of a preliminary authorisation of advertising non-prescription medicines with control ex post. This system is reasonable for medicines, but not for sanitary products. No modification has been introduced in either general or specific regulations related to the advertising of sanitary products. Therefore, the advertising of sanitary products – when such advertising is permitted – requires a preliminary administrative authorisation. The Medicines and Sanitary Products Agency published a note(2) in order to clarify this provision, stating that it will seek a correction of the repeal in order to limit it to the part of Article 102(2) that refers to medicines.
As there are several amendments, the fourth final provision of Act 10/2013 includes an authorisation and a call to the government to issue a redrafted text of the Medicines and Sanitary Products Act within two years. The authorisation includes the ability to regularise, clarify and harmonise the legal texts involved.
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(1) Available at www.notificaRAM.es/.