Tagged with Spain

Pharma Legal Handbook 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Generally speaking, for getting a marketing authorization of a medicinal product, the applicant needs to provide sufficient information to demonstrate that the relevant product fulfills the established quality requirements, is…

Pharma Legal Handbook 1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, there are managed entry agreements in Spain. The most frequent Managed Entry Agreements (MEAs) are financial and performance-based agreements (both at patient and population level).   2. Describe the fundamentals of the…

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles: a. Pricing and impact of generic/biosimilar approval The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…

Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…

Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…

Pharma Legal Handbook 1. What is the definition of a vaccine in your country? The AEMPS defines a vaccine as an antigen-containing preparation capable of inducing specific and active immunity in humans against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of innate and adaptive…

Spain Spanish mid-cap Esteve is selling a 26 percent stake in the company to German private investment firm Lubea, a move it says will supply the necessary funds to further pursue its redefined company strategy while stepping up growth and allowing for additional international expansion. Expansion: Products and Geographies Esteve, a…

Spain The latest news from Spanish pharmaceuticals and healthcare, including national champion Esteve’s decision to sell of a quarter of its stock to German private investment firm Lubea; news of pharma’s increased weighting in Spain’s exports for 2022; and why – bolstered by EU recovery funds – the country has a…

Spain A roundup of the latest news from Spanish pharma, including Almirall’s earnings forecast for 2023; stock price rise and layoffs at Grifols; PharmaMar’s first European approval for its lurbinectedin treatment of metastatic Small Cell Lung Cancer and Esteve’s launch of the first inhaled rescue treatment for Parkinson’s patients.   Spain’s…

Greece The grants and loans allocated by the European Union’s Recovery and Resilience Facility (RRF), a large part of which have been assigned to healthcare, set out to mitigate the economic and social impact of the COVID-19 pandemic, but for many biopharma industry leaders they also present an opportunity to tackle…

Pharma Legal Handbook 1. Which are the main actors involved in public procurement and tendering? There is a high degree of decentralisation in public procurement in Spain. Regarding the public procurement and tendering services of medicinal products there are actors involved at a national level (MOH), regional level (the governments of the Autonomous…

Spain What major regulatory trends are emerging in Europe and in Spain? As one of the founding partners of a law firm focused uniquely on the life sciences industry, Faus & Moliner Abogados, Jordi Faus has been confronting the industry’s unique legal issues for over 25 years. In a recent PharmaBoardroom…