Publications

The Preliminary Bill seeks, broadly speaking, to increase quality assurance for medicinal products and to enhance transparency and communication in decisions relating to medicinal product safety. It has also been drawn up to implement EU Directives 2010/84 and 2011/62 on this subject, while updating the infringement and penalties regime for medicinal products, medical devices and cosmetic products.

In this respect, the Preliminary Bill amending Law 29/2006 on the Safeguards for and the Rational Use of Medicinal Products and Medical Devices has as its purpose:

• Based on Directive 2010/84, to enhance the efficiency of the pharmacovigilance system, moving from a reactive system to a proactive one, with a view to anticipating the safety problems that may be posed by medicinal products so that they can be avoided. In particular, the reform aims to improve communication and transparency in decisions relating to the safety of medicinal products by preparing a list of medicinal products subject to special monitoring, as well as to encourage citizen participation and strengthen the pharmaceutical industry’s obligations.

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• To prevent the entry of falsified medicinal products by implementing Directive 2011/62. In particular, it seeks (i) to strengthen safeguards in the supply of medical products by establishing new “good distribution practices”, (ii) to increase the control of players that participate in the medicinal product distribution chain, (iii) to increase the safeguards for medicinal products originating from a country that does not belong to the European Union with new obligations in inspection activities and (iv) to require supervision of medicinal product warehouses in free trade zones.
• To ensure a uniform procedure for all changes in marketing authorizations, all of which are subject to the same application, assessment and authorization standards. In addition, it seeks to extend to medical devices, cosmetic and personal care products the provisions contained in Law 29/2006 for medicinal products. It also establishes a prohibition on doorstep sales and any type of indirect sale to the public of medical devices as well as on their advertising whenever the health authorities consider such a prohibition is needed. 
• To adjust the amounts that the Spanish Medicinal Products and Medical Devices Agency receives for providing its services (i.e. handling authorization procedures, etc.) and to include new amounts in respect of the new functions entrusted to it by implementing the European directives. Also of note are exceptions to the payment of the charge, for example, for manufacturing medicinal products without commercial interest, but with a health interest.

In short, the inspiration behind the Preliminary Bill amending Law 29/2006 on the Safeguards for and the Rational Use of Medicinal Products and Medical Devices is to incorporate the above-mentioned EU directives into Spanish law in order to increase quality assurance for medicinal products.