Changes on European regulations on orphan drugs
Commission Regulation (EU) 2018/781 amending Regulation (EC) 847/2000 as regards the definition of the term “similar medicinal product”
CAPSULAS Nº 191
Introduction The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called “orphan medicinal products”. Regulation (EC) 847/2000, where the definitions of “active substance” and “similar active substance” are contemplated, was recently amended by Regulation (EU) 2018/781, effective as of 19... Read More
Parallel imports of relabelled medical devices will be easier in the future
Judgement of the Court of Justice of the European Union (CJEU), of 17 May 2018, Junek v. Lohman, Case C-642/16
CAPSULAS Nº 191
The facts of the case This case refers to the parallel import into Germany, by Junek, of medical devices that Lohman had previously placed in the Austrian market. In order to do so, Junek had affixed a small label on the box of the product. This label included only the following information: the name of... Read More
Carencias a “solo dos años” de la entrada en vigor de los reglamentos europeos de PS
El Global
Hace unas semanas comentaba en esta columna la importancia de la transformación que está teniendo lugar en la normativa aplicable a los productos sanitarios (PS) y, entre otras cuestiones, me refería a la magnitud de los cambios que implican los nuevos reglamentos europeos. Ya comentaba entonces, que a pesar de que las disposiciones más importantes... Read More
Las emociones y la propuesta del SPC manufacturing waiver
El Global
La Comisión Europea ha presentado su propuesta del SPC manufacturing waiver, que permitirá que durante la vigencia de un certificado complementario de protección se puedan fabricar, en la UE, genéricos o biosimilares para su exportación a países donde puedan comercializarse sin infringir patentes vigentes. El objetivo es ayudar a las empresas farmacéuticas europeas a aprovechar los mercados... Read More
International Comparative Legal Guide to Product Liability 2018: Chapter 26 – Spain
A practical cross-border insight into product liability work
INTERNATIONAL COMPARATIVE LEGAL GUIDE
Recently the 2018 issue of The International Comparative Legal Guide to Product Liability was published. This Guide offers a practical insight into product liability issues across the world, and includes both general articles on novelties in the field of product liability and country specific Q&A chapters. This year Xavier Moliner has been once again in... Read More
Ensayos clínicos marca España
El Global
Los ensayos clínicos que se llevan a cabo en España son seguros, eficaces y de calidad. Buena prueba de ello son algunos datos objetivos facilitados por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y por Farmaindustria en el marco de la jornada sobre retos y oportunidades para la investigación biomédica en España organizada... Read More
Hacia una mayor coordinación también en el terreno nacional
El Global
Hace poco recogía esta publicación una interesante entrevista con la eurodiputada Dña. Soledad Cabezón, ponente del informe del Comité de Medio Ambiente, Salud Pública y Seguridad Alimentaria del Parlamento Europeo sobre la propuesta de la Comisión Europea relativa a la evaluación de las tecnologías sanitarias en el territorio comunitario. La propuesta de la Comisión pivota... Read More
Tender specifications cannot grant points to the offering of equipment which is not linked to the subject matter of the procurement contract
Judgement 108/2018, of 10 May 2018, of the Administrative Court of Public Procurement of Andalusia
CAPSULAS Nº 190
Introduction The Administrative Court of Public Procurement of Andalusia has declared null and void the tender specifications for the supply of fluid therapy medicinal products because such specifications established as awarding criteria that, in addition to the supply of medicinal products, bidders should also deliver automated cupboards for storing and dispensing medicinal products, as well... Read More
How does the future for homeopathic medicinal products in Spain looks like?
Order SSI/425/2018 on the communication to be made by companies marketing homeopathic medicinal products in Spain under the sixth transitional provision of Royal Decree 1345/2007
CAPSULAS Nº 190
On 28 of April, an order of the Spanish Ministry of Health (MOH) was published in the Official Journal (BOE 103). According to this order, companies that are currently marketing homeopathic medicinal products in Spain in a “transitory situation” must, if they want to continue such marketing, communicate to the Spanish Agency of Medicinal Products... Read More
Spanish Commercial Courts have jurisdiction over debt recovery claims when such claims are related to unfair competition lawsuits
Judgement 147/2018, of 8 March, of the Court of Appeals of Barcelona (Section 15)
CAPSULAS Nº 190
Background This case started when the company Integral filed a lawsuit against Laboratorios Liconsa before the Commercial Court number 3 of Barcelona. In such lawsuit, two legal actions were jointly flied: one action claiming payment of unpaid invoices issued in consideration for certain projects made by Integral; and the other action was based on unfair... Read More