Tagged with EG

Pharma Legal Handbook 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The main bodies in charge of HTA in Spain are the AEMPS, the MOH (particularly the DGCC) and the regional governments; all of such bodies acting in coordination through REVALMED.[1] Also note that, as…

Pharma Legal Handbook Before answering the questions in this Section VI, it is appropriate to make an important consideration. In Spain, at least up to the date of this publication, the HTA evaluation is carried out by public authorities, without the industry having to provide a specific HTA dossier with pharmacoeconomic studies of…

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…

Morocco A highly experienced stalwart of the North African pharma industry, Amine Sekhri today heads up AstraZeneca’s operations in Morocco. In his latest PharmaBoardroom conversation, Sekhri shares his delight at the positive healthcare transformations taking place across Morocco and Africa, gives his insight into the market access landscape for AstraZeneca’s most…

Morocco Servier Morocco, with its robust portfolio of 15 products and a turnover of EUR 30 million, has forged a leading position in the local market. Managing Director Florent Darchez explains the affiliate’s goal to expand its oncology footprint while aligning with national coverage policies to broaden overall access to its…

UAE MSD GCC’s Ashraf Mallak looks back on a “transformational” two years since his last PharmaBoardroom interview back in 2021, with the set up of a new regional office, a raft of new launches and expanded indications, and the landmark inclusion of its HPV vaccine on various national immunization programs. Mallak…

Brazil The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This…