More possibilities in relation to the substances that can be used in the manufacturing of food supplements
Royal Decree 130/2018, of 16 March, amending the Royal Decree 1487/2009, of 26 September, regarding food supplements
CAPSULAS Nº 189
Background On 28 March 2018, the Royal Decree 130/2018, of 16 March, amending Royal Decree 1487/2009, of 26 September, regarding food supplements, came into force. The purpose of the new Royal Decree is to update and clarify the regulatory framework applicable to food supplements in Spain. The main aspects regulated by this new regulation are... Read More
Faus & Moliner participates at the Conference Impact of the new Law on Public Sector Contracts in the pharmaceutical sector organized by CEFI
Jordi Faus makes a presentation on Equivalent Therapeutic Alternatives
Jordi Faus makes a presentation in Madrid called ¿Are the lots by indication possible after the judgment of the Supreme Court on the Equivalent Therapeutic Alternatives (ETAs)?
No definitivo a las ATEs. Los medicamentos distintos no deben agruparse en un mismo lote
CUADERNOS DE DERECHO FARMACÉUTICO, NÚM. 64, ENERO-MARZO 2018
The new Spanish law on public tenders promotes the division of the contract into lots “as long as the nature or object of the contract allows such division”. The previous rule, which imposed that a justification was given when the contract was divided into lots, is reversed and replaced by the new rule, which only... Read More
Hay productos con el mismo API que no son el mismo medicamento
EL GLOBAL
Inmersos como estamos en los trabajos de modificación del sistema de precios de referencia, una reciente sentencia del Tribunal General de la UE aporta elementos de reflexión sumamente interesantes al debate en torno a cuándo dos productos deben considerarse el mismo medicamento. En el sistema actual, pueden incluirse en el mismo conjunto de referencia aquellos... Read More
Faus & Moliner maintains its leadership in pharmaceutical law in Spain
Jordi Faus is once more recognized as the best lawyer in Spain in pharmaceutical law by the Guide Chambers & Partners 2018
Chambers & Partners has published the edition 2018 of the Chambers Europe Guide, which, based on opinions of clients and other lawyers, identifies and classifies the main lawyers and firms in Europe and Faus & Moliner is once more considered as a leading firm in the area of pharmaceutical law in Spain. The clients consulted by the team of Chambers & Partners highlight the high degree of specialization... Read More
No olvidemos la importancia y los beneficios del ‘compliance’
EL GLOBAL
A estas alturas ya son pocas las compañías farmacéuticas o del sector de los productos sanitarios que no tienen asumida la importancia de contar con un sistema de complianceadecuado. Aun así, cada vez es mayor la frecuencia de noticias que, siendo más o menos cercanas, nos recuerdan que no podemos olvidarnos del compliance. De hecho, últimamente hemos... Read More
Cosméticos más seguros
EL GLOBAL
El pasado 28 de febrero entró en vigor el nuevo Real Decreto 85/2018 por el que se regulan los productos cosméticos. Esta norma viene a sustituir al Real Decreto 1599/1997 sobre cosméticos y, juntamente con el Reglamento (UE) 1223/2009, en vigor desde 2013, conforma el actual marco normativo de referencia en España en lo que... Read More
Piden acceso a las Actas de la Comisión de Precios de 2007 a 2017: transparencia y finura
EL GLOBAL
La Ley 19/2013, de transparencia y acceso a la información pública entró en vigor hace cuatro años, y desde finales de 2014 se aplica a la Administración General del Estado. Es una ley compleja, pero que parte de un principio muy sencillo: todas las personas tienen derecho a acceder a la información pública. Todas quiere... Read More
A final “No” to tenders for “Therapeutically equivalent alternatives”
The Supreme Court, in a judgement of 29 January, rules in favour of an appeal prepared by Faus & Moliner representing one of our clients
CAPSULAS Nº 188
Background In July 2013, the Healthcare Service of Andalucia (SAS) opened a tender for a framework agreement with the intent of selecting certain active ingredients to treat specific diseases. The purpose of the contracting authority was to select, for certain therapeutic indications, one single company who would supply a given drug among those which could... Read More
Final countdown for the implementation of the European Regulation of Data Protection
Regulation (EU) 2016/679, of 27 of April of 2016, on the protection of natural persons with regard to the processing of personal data and the free movement of such data
CAPSULAS Nº 188
On 25 of May the General Data Protection Regulation (GDPR) will be implemented. From then onwards, the GDPR will be the reference standard, and the current regulations of each Member State will be repealed. Therefore, in Spain, Organic Law 15/1999, on Data Protection will be repealed. Many of the concepts and mechanisms contained in the... Read More