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Legal changes after the Directive 2011/62/EU in Spain

The Spanish legislation was revised and updated to incorporate into the Spanish legal system the recent directives that have amended directive 2001/83/EC. The goal is not only to adapt national laws to EU scenario, but also to guarantee the proper working of internal markets for medicines ensuring a high level of health public protection.

Royal Legislative Decree 1/2015, of 24  July, approving the restated text of the Law of guarantees and rational use of medicines and medical devices is the legal framework which establishes the provisions, among others, about the evaluation, authorization, registration, manufacture, storage, distribution and following up of the benefit-risk ratio of medicines at a national level , in order to ensure their security, efficacy and quality. The ACT also includes provisions on distant sales of medicinal products:

  • the sale at a distance is limited to non-prescription medicinal products
  • the medicinal products may be sold online only if they are dispensed by an authorized pharmacy (‘brick and mortar’)
  • the medicinal products may be sold online only if there is a clear intervention of a pharmacist and with a prior personal counselling. Customer information is required to facilitate the contact by the pharmacist with the object of creating a two-way interaction channel with whom the pharmacist must ensure that the customer receives all the pertinent information, replies to any request of information and properly monitors the follow–up of the treatment

The new  regulations in pharmacovigilance , as regards the prevention of the entry into the legal supply chain of falsified medicinal products , among others, triggered the modification amendment of the aforementioned royal decree 1/2015, of 24 of July.

Concerning the provisions applicable to the sales at distance of medicines, they have been further developed in detail in a decree (royal decree 870/2013, of 8 November 2013, regulates the sale at a distance to the public, through websites, of non-prescription medicines of human use).

The royal decree 870/2013 provides a legal framework for the sale at a distance of non-prescription medicines for human use only, through internet websites, aiming to ensure protection of consumer’s health and rights. It facilitates the identification of the websites that legally sell non-prescription medicinal products by obliging them to display the EU-logo. Pharmacies performing sales at a distance are listed in websites managed by competent authorities, so the public can verified they are legal.

This royal decree sets out detailed requirements for pharmacies selling non-prescription medicines at a distance: to report its activity to competent authorities for supervision and control, to display a minimum information, the professional role of the pharmacist, record keeping, etc. It also empowers the authorities to impose quantitative restrictions on internet sales of certain medicines with risk of abuse or misuse.

From June 2015, pharmacies will be allowed to begin the activity of selling non-prescription medicinal products over the internet provided that they notified regional authorities, at least 15 days before starting the activity. This notification shall be accompanied by the following information:

  • details of the responsible pharmacist
  • the intended start date for the activity
  • the website URL address
  • information about the procedure to deliver the medicinal products sold over the internet

The autonomous regions will forward all this information to AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), that will compile these data and make them available upon request by other Member States or the European Commission. The autonomous regions’ health authorities and the AEMPS have to create websites with information about the applicable legal conditions and the risks of buying from illegitimate websites as required by the directive. In addition to transpose the directive, the royal decree contains some specific provisions on medicinal products sold at a distance. These issues are:

  • the customer should be informed about the approximate delivery time
  • the sale must be direct, from the pharmacy to the patient, without any intermediaries
  • the law on data protection must be applied and all the records of the distant sales must be retained by the pharmacist for inspection purposes
  • the pharmacist must guarantee the transport and the delivery of the medicinal products, even if this activity is outsourced by a written contract
  • presents and bonus are forbidden and the discounts must be according to the applicable legal provisions
  • the online sales to patients in other MMSS (EU Member States) must comply with the requirements established in the Spanish legislation as well as the applicable ones in the country of destination
  • the pharmacist must assess the orders and all the suspected cases (unusual quantities, repeated requests, etc.) or purchase’s requests that could indicate a potential misuse
  • the pharmacy should verify safety features as applicable, as would do in physical sales

The decree also prescribes some minimum information to be displayed in the website, such as:

  • information about pharmacy holidays or closings
  • prices of medicinal products and delivery costs
  • code/s of conduct adhered, when applicable
  • permanent, easy, direct and free access to the contact information of the pharmacy

The overall goal of all these provisions is to ensure the guarantees when dispensing medicines online as equivalent to those in face-to-face dispensing.

For further information:

Royal decree 1/2015

Royal decree 870/2013

directive 2001/83/EC