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…
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