Un impulso a la investigación clínica en España
AMIFE
Desde hace ya un tiempo el mundo sanitario y farmacéutico está siendo objeto de numerosas y profundas reformas normativas, lamentablemente no siempre positivas para estos sectores. Dentro de estas pocas reformas que nos atrevemos a calificar de positivas está la modificacion de la normativa que regula la investigación clínica con medicamentos de uso humano en... Read More
The novelties introduced in Law 29/2006 on Guarantees and Rational Use of Medicinal Products and Medical Devices come into force
Law 10/2013 which incorporates Directives 2010/84/EU and 2011/62/EU, and modifies Law 29/2006 (Official Journal No 177, 25 July 2013)
CAPSULAS Nº 145
Introduction After its parliamentary procedure was finished, on 25 July Law 10/2013, which amends Law 29/2006 on Guarantees and rational use of medicinal products and medical devices, was published in the Official Journal. The provisions of Law 10/2013 came into force immediately, the next day after its publication. The initial objective of the project, as... Read More
Más sobre alternativas terapéuticas equivalentes
EL GLOBAL
En España, donde somos proclives a las definiciones y a las siglas, sería bueno poner pausa en el debate sobre las alternativas terapéuticas equivalentes (ATEs). De otro modo nos arriesgamos a que cuaje la idea de que existen productos que son ATEs, que nos inventemos algún símbolo para ellos o alguna campaña de comunicación, y... Read More
Alternativas Terapéuticas Equivalentes
Juan Suarez speaks about the legal framework for declaring that two medicines are therapeutically equivalent
In recent times, the debate about when and how two or even more medicines may be declared therapeutically equivalent has become more and more important in Spain. Many Spanish regions and hospitals are taking the view that they may rule that some products are equivalent and then direct prescribers to use the one with the... Read More
Faus & Moliner participates at the XLIX Fuinsa Meeting on Therapeutic Equivalence
Juan Suarez speaks about the legal framework for declaring that two medicines are therapeutically equivalent
In recent times, the debate about when and how two or even more medicines may be declared therapeutically equivalent has become more and more important in Spain. Many Spanish regions and hospitals are taking the view that they may rule that some products are equivalent and then direct prescribers to use the one with the... Read More
Liability for defective product: the importance to inform about the identity of the manufacturer or importer
Judgment of the Provincial Court of Santa Cruz de Tenerife, of 18 March 2013, which dismisses the claim by a consumer against the suppliers of the product
CAPSULAS Nº 144
Background A consumer, keen on practicing frontenis, went to the famous sports store “Decathlon” to purchase some glasses from the brand called “Ikus”, made from polycarbonate highly resistant to the impacts generally received by those who practice this sport. For some reason, the consumer suffered a damage, according to him produced by such defective glasses,... Read More
The Ministry releases the draft for the new regulation on trials with medicinal products and medical devices
Draft Royal Decree which regulates clinical trials with medicinal products, ethics committees on investigation with medicinal products and the registry of clinical trials
CAPSULAS Nº 144
Last May the Ministry of Health, Social Services and Equality released a new draft Royal Decree, through which very important changes will be introduced in the current regulation of clinical trials with medicinal products and medical devices in our country. Through these changes the Ministry aims at anticipating the new European regulation on this matter... Read More
The Spanish Competition Authority cannot do it all, but it can cooperate to improve the legal framework
Regarding the Resolution of the Spanish Competition Authority of 24 May 2013, Case Entecoi, and the reform of the rules regarding prices and reimbursement of medicinal products
CAPSULAS Nº 144
Background In this case, the company Entecoi decided to file a complaint against the administration of the Autonomous Region of Madrid because it was denied an authorization for a technical project of low-voltage electricity. The complainant put forward that with its refusal, the administration prevented its access to the market, and that free competition was... Read More
A new method for submitting proposals in public tenders: the “inclusive offer”
Report 11/2013, of 22 of May, of the Consultancy Board for Public Procurement of the Autonomous Region of Aragon
CAPSULAS Nº 144
Background The General Technical Secretary of the Department of Health, Social Welfare and Family of the Autonomous Region of Aragon raised the following issue before the Consultancy Board for Public Procurement of such Region: if in a bid the object of the contract is divided into various lots, is it possible to include in the... Read More
Nociones de Derecho para Departamentos Técnicos de la Industria
Juan Suarez speaks about Spanish Administrative Law at a course aimed to persons working in the pharmaceutical industry
The University of Barcelona, conscious of the importance that regulations have in the pharmaceutical sector, has decided to organize a course to deal with some general aspects of Spanish administrative law. Faus & Moliner partner Juan Suarez, whose professional career includes several years at the legal department of the Ministry of Health and of the... Read More