## [Pharma Updates 2-2013](/pt/en_GB/new/pharma-updates-2-2013) # Pharma Updates 2-2013 11 / 25 / 2013 - - [](https://www.linkedin.com/sharing/share-offsite/?url=https://www.garrigues.com/pt/en_GB/new/pharma-updates-2-2013) - []() - []() [Download Pharma Updates 2-2013 ![Download](/sites/default/files/inline-images/flecha-abajo.png)](/sites/default/files/noticias/files/Fharma-Updates-2-2013_1.pdf) Previous Next 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** ### Contact ![](/sites/default/files/styles/medium/public/team/photo/10000844.jpg?itok=-NjfKDZv) [José Fernández-Rañada](/pt/en_GB/team/jose-fernandez-ranada-lopez-doriga) ![](/themes/custom/garriguestheme/img/iconos/email-contacto.svg)[Contact]() - +34 91 514 52 00 [Madrid](https://www.garrigues.com/pt/en_GB/office/madrid) [Find more professionals](../team) ### Related services - [Life Sciences and Healthcare ](/pt/en_GB/services/life-sciences-and-healthcare) - ## Find a publication - [Administrative and Constitutional Law](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1422) - [Agribusiness and Food](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1417) - [Automotive](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1419) - [Banking and Finance](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1443) - [Corporate and M&A](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1441) - [Criminal Law and Internal Investigations](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1434) - [Data Economy, Privacy and Cybersecurity](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10913) - [Dispute Resolution: Litigation and Arbitration](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1412) - [Energy](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10916) - [EU and Antitrust Law](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1416) - [Family Business](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1413) - [Fashion Law](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1435) - [Financial Regulation](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10915) - [Human Capital Services](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1431) - [Infrastructure](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10914) - [Insurance](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1438) - [Intellectual Property](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1421) - [Labor and Employment](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1424) - [Life Sciences and Healthcare](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1429) - [Media and Entertainment](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1433) - [Planning, Zoning and Environment](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1444) - [Private Equity](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1439) - [Real Estate](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10927) - [Restructuring and Insolvency](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1420) - [Securities Markets](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1442) - [Sports](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1430) - [Startups & Open innovation](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1426) - [Sustainability](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A10921) - [Tax](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1425) - [Technology, Communications and Digital](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1436) - [Tourism and Hotels](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1432) - [Transport, Logistics and Shipping](/pt/en_GB/markdownify/node/4442?f%5B0%5D=service%3A1428) Facet Services detail - [Publications](/pt/en_GB/markdownify/node/4442?f%5B0%5D=publication_type%3A794) - [Newsletters](/pt/en_GB/markdownify/node/4442?f%5B0%5D=publication_type%3A107) - [Garrigues collection](/pt/en_GB/markdownify/node/4442?f%5B0%5D=publication_type%3A101) - [Laws: amendments at a glance](/pt/en_GB/markdownify/node/4442?f%5B0%5D=publication_type%3A104) - [News](/pt/en_GB/markdownify/node/4442?f%5B0%5D=publication_type%3A105) Facet Publication type detail Min Max ## News search engine