Tagged with Assessment

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…

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…

Tunisia Riadh Daghfous, managing director of the Tunisian National Pharmacovigilance Center (CNPV), describes the role of the CNPV in side-effect monitoring, pharmacovigilance, and marketing authorizations. CNPV plays a central role in Tunisia’s health system. Could you explain the CNPV’s main operating features, its means and attributions, as well as its interactions…