VALTERMED
CUADERNOS DE DERECHO FARMACÉUTICO, NUMBER. 71, OCTOBER-DECEMBER 2019
Valtermed is the new information system of the National Health System (NHS) which aims to generate, store and make available relevant information for the determination of the real therapeutic value provided by the medicinal products used in the NHS. Valtermed has very solid foundations that justify its creation to respond to very specific needs related... Read More
El Tribunal de Justicia de la UE aboga por la transparencia
El Global
Una de las preguntas que más quebraderos de cabeza ha generado a la industria farmacéutica en los últimos años ha sido si el titular de la autorización de comercialización de un medicamento puede recurrir contra la autorización otorgada a otro medicamento con las mismas sustancias activas y solicitar a un tribunal que revise la concesión... Read More
About the “Action Plan to promote the use of market regulatory medicines in the NHS: biosimilar and generic products”
CUADERNOS DE DERECHO FARMACÉUTICO, NUMBER. 71, OCTOBER-DECEMBER 2019
The Spanish Ministry of Health has published its proposal of an Action Plan to foster the use of biosimilar and generic products, referring to them as medicinal products that regulate the market within the Spanish National Health System. This article comprises some of the ideas that Faus & Moliner put forward in a personal and... Read More
A tiempo de presentar pruebas
El Global
No es poco habitual que un órgano de contratación tome la decisión de excluir a una empresa de la licitación con el fundamento de que la oferta presentada no cumplía con las especificaciones técnicas que exigían los pliegos. Dichas decisiones suelen ser recurridas por los licitadores excluidos mediante el correspondiente recurso especial en materia de... Read More
Cuatro años, “keep calm”
El Global
De acuerdo con el artículo 113 de la Constitución, la destitución de un Presidente del Gobierno y el nombramiento de otro mediante una moción de censura requiere mayoría absoluta, es decir el voto favorable de al menos 176 diputados (la mitad más uno del total). A diferencia de lo que sucede en la investidura, en... Read More
Pacientes empoderados
El Global
A lo largo de nuestra vida todos somos, en mayor o menor medida, pacientes. Por este motivo, nuestros datos más sensibles, como son los relativos a nuestra salud, pasarán inevitablemente por las manos de médicos y demás profesionales sanitarios, centros de salud y hospitales, tal vez promotores de ensayos clínicos, autoridades sanitarias, compañías de seguros,... Read More
New Spanish rules on commercialization, supply and control of medicinal products for human use
Royal Decree 717/2019 modifying Royal Decree 1345/2007 regulating the authorization procedure, and dispensation conditions for medicinal products for human use
Introduction On 6 December 2019, Royal Decree 717/2019 was published on the Spanish Official Gazette. This Royal Decree modified another one, which regulates the authorization procedure and dispensation conditions for medicinal products for human use. Here are some of the main modifications: Ceasing commercialization Pursuant to article 23a of Directive 2001/83/EC, the marketing authorization holder... Read More
How a supplier should act upon receiving a product liability claim
Judgement of the Court of Appeals of Islas Baleares of 5 September 2019
Introduction In our Capsulas Newsletter of September 2019 we explained that a supplier may be able to avoid the direct product liability foreseen in Royal Decree 1/2017 if it identifies the producer of the product or if it is notorious that the injured party, before addressing any communication to the supplier, knew who was such... Read More
Legal consequences of the electronic notifications in the administrative procedures
Judgment of the National High Court of 25 September 2019
Capsulas Nº 206
This judgment confirms the resolution of the Spanish Data Protection Agency (AEPD) that sanctioned the company Avon Cosmetics for breaking the rules on data protection. The sanction procedure was initiated by the AEPD following a complaint submitted by an individual whose personal data was processed by Avon. Some practical matters can be drawn from this... Read More
Four lawyers of Faus & Moliner distinguished in the guide The Best Lawyers in Spain
The guide Best Lawyers has published its edition for the year 2020 for Spain
The legal guide The Best Lawyers in Spain has recently launched its 12th edition for the year 2020, in which, on the basis of nominations by professional collegues, made through the website of Best Lawyers, the main lawyers and firms are identified and classified according with the practice areas and the geographic region. The 3.709... Read More