Approval process for COVID-19 vaccines v.2
Adaptation of vaccines to new SARS-CoV-2 variants
Capsulas Nº 216
Introduction On 23 December 2020, two days after the European Medicines Agency (EMA) issued its favorable opinion on the authorization of the Covid-19 vaccine developed by BioNTech and Pfizer and, in a context in which there were voices expressing certain concern about the safety of the vaccines, we published a special CAPSULAS aimed to dispel... Read More
The importance of quality and safety controls for medical devices
Judgement of the Supreme Court of 1 March 2021
Capsulas Nº 216
Background A manufacturer of a hip prosthesis, after becoming aware that the product had to be revised more often than expected, issued a safety notice recommending wearers of the affected prosthesis to follow a specific monitoring and control plan. Several months later, the manufacturer voluntarily withdrew the product from the market. Afterwards, a patient underwent... Read More
Sanidad, Anefp y Autocontrol lo tienen claro: Mejor prevenir que curar
El Global
El BOE ha publicado el convenio de colaboración, en materia de publicidad de medicamentos dirigida al público, suscrito entre el Ministerio de Sanidad, la Asociación para el Autocuidado de la Salud (Anefp) y la Asociación para la Autorregulación de la Comunicación Comercial (Autocontrol). Este convenio, suscrito el 22 de marzo de 2021, sustituye a otro... Read More
Estudios Observacionales y Programas de Soporte a Pacientes: Comentarios al Real Decreto 957/2020
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 76, JANUARY-MARCH 2021
This article aims to describe and comment the regulatory framework applicable to observational studies with medicines for human use foreseen in Royal Decree 957/2020. Likewise, it provides the opinion of the authors with respect the ongoing debate regarding the impact of such Royal Decree on the regime applicable to patient support programs.
I love my lawyer
El Global
Hoy les hablaré de uno de los signos distintivos a mi juicio más relevantes en el ejercicio de la abogacía, que también compartimos con la profesión médica: el secreto profesional. Ambas profesiones se basan en una relación de confianza, ya sea abogado-cliente o médico-paciente, que imponen a quienes la desempeñan el derecho, y también el... Read More
Faus & Moliner participates in «The Legal 500: Product Liability Country Comparative Guide»
Xavier Moliner and Juan Martínez write the chapter regarding product liability in Spain
The Legal 500 Country Comparative Guides
The aim of this guide is to provide its readers with a general overview of current Product Liability laws and regulations in each of the jurisdictions to which it refers. Each chapter of this guide provides information about objective product liability, non-contractual and contract liability and litigation that can be raised on these matters.
Faus & Moliner participates in the “Chambers Global Practices Guides – Pharmaceutical Advertising 2021″
Jordi Faus, Verónica Carías and Laura Marquès write the chapter about Law and Practice in Spain
CHAMBERS GLOBAL PRACTICES GUIDE
The ‘Law & Practice’ sections provide easily accessible information on navigating the legal system when conducting business in the jurisdiction. Leading lawyers explain local law and practice at key transactional stages and for crucial aspects of doing business.
Faus & Moliner will participate at the Breakfast organized by FEDER on the challenges to access the Diagnosis Treatment in rare diseases
Lluis Alcover will speak about the Report on medicines with an express resolution of no reimbursement
On 11 April 2019, the General Directorate of the National Health System (NHS) and Pharmacy issued a document entitled “Report (…) on the public reimbursement of medicines with an express resolution of non-inclusion in the pharmaceutical provision of the NHS” concluding that the medicinal products that have obtained an express resolution of non-reimbursement are medicinal... Read More
Competencia, contratos públicos y compliance
El Global
La resolución de la Comisión Nacional de los Mercados y la Competencia en el asunto de los radiofármacos es un documento extenso (+140 pgs) que puede leerse desde distintos ángulos y que permite diversas reflexiones interesantes. Aunque la complejidad de estos temas puede hacer aconsejable hace un estudio más reposado adaptado a cada caso concreto,... Read More
Faus & Moliner reinforces its team
Santiago Tomás and Anna Gerbolés join the team of Faus & Moliner
Santiago has more than 8 years of professional experience. He specializes in regulatory affairs of the pharmaceutical sector and public procurement. He joins F&M from the Public and Regulatory Law area of Cuatrecasas, where he began his career. With his incorporation, Faus & Moliner reinforces its regulatory team, and consolidates its capabilities with regard to... Read More