Following the creation of the National Pharmacy and Therapeutics, in February 2013, it has now been published in the Official Gazette, the Order 7841-B/2013 of June 17, which defines the criteria that must be satisfied on the elaboration of the National Formulary of Medicinal Products ("FNM"). On the same day, the new National Formulary of Medicinal Products, prepared by the Committee, was also presented.
According to the Order that establishes the principles and rules for the elaboration of the FNM, it is strengthen that it is mandatory, being immediately established as a general rule that medicinal products that are not the in FNM or in one of its addenda cannot be acquired by the establishments and services of the National Health Service ("NHS"). In this regard, it should be pointed out the rule that, in the context of public procurement (or other procurement procedures), the purchase of medicinal products by the NHS establishments may only be allowed provided that the proposal to initiate the procedure includes an information from the Pharmacy and Therapeutics Committee of the Hospital or Regional Health Authority, at stake, where it states that the medicinal product to be acquired is included in the FNM, or on one of its addends.
Still, the Order establishes the possibility for the services and facilities of the NHS to purchase medicinal products that are not yet available in FNM, or its addenda. For that, the medicinal products to be purchased must be approved by the respective establishments, and the proposal to initiate the procedure shall include a information from the National Hospital Pharmacy and Therapeutics, or ARS concerned, which states that the medicinal product is included in the addendum approved by the service purchaser and that the product is intended for a condition not yet the subject of a monograph or therapeutic protocol in FNM.
We also note that the non-compliance with these rules is severely punished. Indeed, administrators or directors of NHS hospitals and Regional Health Administrations authorizing the purchase of medicinal products in violation of the provisions of the Order may be civilly, criminally and financially responsible.