The Department of Health regulates the Internet sale of medicinal products for human use that do not require medical prescription

Royal Decree 870/2013, of 8 of November, regulating the distance sale to general public, through Websites, of medicinal products for human use not subject to medical prescription

Eduard Rodellar

CAPSULAS Nº 148

Law 29/2006 limited the Internet sale to the medicinal products that were not subject to a medical prescription, as long as they were supplied by a pharmacy, with the intervention of a pharmacist, after such pharmacist has provided personalized advice and in accordance with the rules applicable to the medicinal products to be sold. The rest of the requirements were pending for further implementing regulation. This recent Royal Decree implements now such legal provision.

Fight against illegal sale

Royal Decree 870/2013 intends to provide Internet sale with the necessary healthcare guarantees, and to distinguish more easily the Websites that are legally selling medicinal products from those that are not legal, in order to fight against counterfeit and unauthorized medicines. For this purpose, the authorized Websites shall have to incorporate a European logotype, that will moreover permit to identify the Member State in which it is established who performs the sale. In order to sell via Internet, the pharmacy must  previously communicate its intention to the competent autonomous authority, and must meet the requirements of the Royal Decree. If the buyer is in another Member State, such sale shall have to be made, moreover, in accordance with the requirements that apply in the country of destination.

Both the regional authorities as well as the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) shall have to create a Website that including updated information regarding the Websites of the registered pharmacies. The qualitative or quantitative limitations that the AEMPS might establish for the Internet sale of certain medicinal products shall also be published, due to their potential misuse.

Promotion and advertising

No gifts, discounts or similar offers connected with the promotion or sale to the public of medicinal products through Websites can be made, except for legally admitted discounts. The name of the Website cannot mislead or create false expectations regarding the possible benefits for the health status. The available medicines shall have to be identified with the name of the authorized presentation, and their information shall have to correspond literally with the prospect authorized by the AEMPS.

Dispensing and returns

The pharmacist shall have to evaluate whether it is pertinent or not to dispense, especially if the requests exceed the quantities used in standard, frequent or reiterated treatments, that could lead to misuse or abuse of the medicines being sold. Except in some cases, the pharmacy will not accept returns of already supplied medicinal products. The consumer is being recognized the right to return the medicine and to be refunded the amount paid for causes not attributable to him.

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