Law on Guarantees and Rational Use of Medicines and Medical Devices.
Royal Decree 109/2010, of February 5, 2010, amending various royal decrees on health matters for their adaptation to Law 17/2009, of November 23, 2009, on free access to service activities and the exercise thereof, and to Law 25/2009, of December 22, 2009, amending various laws for their adaptation to the Law on free access to service activities and the exercise thereof.
The transposition of the Services Directive is presented as an opportunity to establish a true area without borders, where the freedom to provide services and the freedom of establishment, enshrined in Articles 43 and 49 of the Treaty establishing the European Community, are guaranteed.
Along the same lines as the previous one and for the same reasons, Royal Decree 1030/2006, of September 15, which establishes the portfolio of common services of the National Health System and the procedure for its updating, is amended.
Also for this reason, Royal Decree 1345/2007, of October 11, 2007, which regulates the procedure for the authorization, registration and dispensing conditions of industrially manufactured drugs for human use, is amended to eliminate the references to the so-called “advertising drugs”.
Law on Medicines
IN VIEW OF File Nº 1-2002-12498/99-5 of the Registry of the former MINISTRY OF HEALTH and SOCIAL ACTION, and Decree Nº 1269 of July 20, 1992 by which the Substantive and Instrumental Health Policies are approved; and
That within the framework of the policies of the MINISTRY OF HEALTH of the Nation, the NATIONAL PROGRAM OF QUALITY ASSURANCE OF MEDICAL CARE is developed, which groups together a set of actions aimed at assuring the quality of the services rendered in said Services.
That the aforementioned guidelines and standards are prepared with the participation of Academic, University and Scientific Professional Entities, thus ensuring the participation of all the areas involved in the Health Sector.
That the DIRECTORATE OF HEALTH CARE PROGRAMS AND SERVICES has coordinated the process of elaboration of the ORGANIZATION AND OPERATING RULES OF PHARMACY IN HEALTH CARE ESTABLISHMENTS, in accordance with the regulations in force, with the participation of the FACULTY OF PHARMACY AND BIOCHEMISTRY (UBA); ARGENTINE PHARMACY SOCIETY; ASSOCIATION OF MEDICAL SCIENCES FACULTIES OF THE ARGENTINE REPUBLIC (AFACIMERA); NATIONAL ACADEMY OF MEDICINE (ANM); ARGENTINE MEDICAL ASSOCIATION (AMA) and ARGENTINE PHARMACEUTICAL CONFEDERATION.
Regulation of veterinary medicinal products
The purpose of this Law is to protect the health of consumers, guaranteeing them the availability and accessibility of effective, safe and quality medicines; for such purpose it shall regulate:
Likewise, the applications for authorization of pharmaceutical establishments and sanitary registration, shall be elaborated and endorsed by a pharmaceutical professional; without prejudice to the administrative procedures carried out by legal professionals in this regard.
The technical and administrative actions necessary to guarantee the evaluation, registration, control, surveillance, execution, quality verification and sanitary surveillance of medicines for human use, medicated cosmetics and medical devices shall be exercised through the corresponding unit and its quality control laboratory.
Article 7.- No natural or juridical person may manufacture, import, export, distribute, commercialize, prescribe, dispense, experiment or promote medicines, raw materials or medical supplies without the previous authorization and sanitary registration of the corresponding agency of the Ministry of Health. The General Directorate of Customs and other State agencies shall require the respective authorization and sanitary registration of the Ministry of Health.
Regulation of medicines in Spain
In this respect, the role of the professionals in the sector has been fundamental in achieving these goals. The physician is a central figure in the strategies to promote quality in pharmaceutical services, given the role attributed to him/her in the patient’s health care and, therefore, in the prevention and diagnosis of the disease, as well as in the prescription, if necessary, of drug treatment. The work that pharmacists and other healthcare professionals carry out in pharmaceutical care procedures is also of essential importance as it ensures accessibility to medication by offering, in coordination with the physician, health advice, pharmacotherapeutic monitoring and professional support to patients.
The challenge remains, even more so in the current economic situation, to ensure the quality of provision throughout the National Health System in a decentralized framework capable of promoting the rational use of medicines and in which the central objective is that all citizens continue to have access to the medicine they need, when and where they need it, in conditions of effectiveness and safety.