Article 20.1 of the Organic Law 15/1999 of 13 December on the Protection of Personal Data, provides that the creation, modification or deletion of the files of the Public Administrations may be made only by means of general provision published in the Official Journal of the State or the official journal concerned.

By this order, we proceed to amend the Order of 21 July 1994, which regulates the files with personal data managed by the Ministry of Health and Consumer Affairs, creating a new file called "EAMI network alert distribution lists" with personal data, managed by the Ministry of Health, Social Services and Equality.

This file consists of different data from those persons or collectives that subscribe to the alerts distribution lists of the Network of Authorities in Latin American Medicines (EAMI) with the object of receiving information on public alerts on the safety, quality or falsification of medicinal products issued by the authorities in medicinal products in the countries of Latin America that make up the network.

In the processing of this order, the Spanish Data Protection Agency has issued a mandatory report.

In its virtue, I have:

Article 1. Creating a file.

The contents of Annex 1 "Health Ficheros" of the Order of 21 July 1994, for which files are regulated with personal data managed by the Ministry of Health and Consumer Affairs, are extended, with the the creation of a new automated file called "EAMI Network Alert Distribution Lists", the data of which are listed in the Annex to this order.

Article 2. Managing and organizing the file.

The owner of the body responsible for the file shall take the necessary management and organizational measures, ensuring, in any case, the confidentiality, security and integrity of the data, as well as the conduct to be the guarantees, obligations and rights recognised in the Organic Law 15/1999 of 13 December, the Protection of Personal Data, and Royal Decree 1720/2007 of 21 December, approving the implementing regulation of the Organic Law 15/1999, of 13 December, on the protection of personal data.

Article 3. Data cession.

The data contained in this file may only be transferred in the cases expressly provided for by law.

Single end disposition. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, July 30, 2015. -Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.

ANNEX

Creating the file

File name: EAMI network alert distribution lists

Purpose of the file: Report of the public alerts issued by the authorities in medicines of the countries of Latin America.

Persons or collectives on whom they are intended to obtain personal data or who are obliged to supply them: Persons interested in receiving the security alerts, quality and counterfeit medicines issued by the authorities in medicines from Latin America (EAMI network).

Personal Data Collection Procedure: Using a computer form, which will populate people who want to receive alerts.

Basic file structure and description of personal data types: Computer database. Name and surname of the person concerned, e-mail address and country.

Treatment system: Automated.

Data on personal data and/or data transfers that are provided to third countries: No transfers of data to third countries are foreseen.

Expected data communications: None.

Organs of the Administrations responsible for the file: General Secretariat of the Spanish Agency for Medicines and Health Products.

Services to which the right of access, rectification, cancellation and opposition may be exercised: Division of Information Systems, General Secretariat of the Spanish Agency for Medicines and Health Products, street Campezo, 1, building 8, 28022 Madrid.

Security measures with level indication: Basic.