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Pharma Updates 2-2013

11/25/2013
Commentaries

ROYAL DECREE REGULATING THE SALE AT A DISTANCE TO THE PUBLIC, THROUGH WEBSITES, OF MEDICINAL PRODUCTS

Introduction

Directive 2011/62/EU, of 8 June 2011 (the “Directive”), amending 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, regulates at EU level, among other matters, the basic requirements to be incorporated by Member States into their national laws for establishing an adequate system for controlling and monitoring procedures for the sale of non-prescription medicinal products to the public through websites.

In turn, although article 2.5 of Law 29/2006, of July 26, 2006, on the Safeguards for and the Rational Use of Medicinal Products and Medical Devices (the “LGURMPS”) established that the sale of medicinal products by telematic procedures was limited to non-prescription medicinal products, Law 29/2006 left the rules on this type of sale to be fleshed out by implementing regulations.

Royal Decree 870/2013, of November 8, 2013, regulating the sale at a distance to the public, through websites, of non-prescription medicinal products for human use (the “RD”) was published in the Official State Gazette on November 9, 2013.

The RD entered into force the day after its publication in the Official State Gazette (i.e., on November 10, 2013) and establishes the requirements to be met by websites selling medicinal products legally in Spain, in order to ensure they are sold with the due safeguards and incorporate the provisions established at European Union level in the Directive.

In the following sections, we take a look at the most important changes ushered in with the publication of the RD.

1. Subject matter and scope of application

2. Requirements to start up the activity of online sale

3. Communication and control by the AEMPS and the competent authorities

4. Specific dispensing requirements

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