Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What is the definition of a vaccine in your country? According to the Decree Law 176/2006, 30 August 2006 (Medicinal Products Act), vaccines are classified as immunological medicinal products.   2. What are the classifications of vaccines in your…

Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of a vaccine in your country? In Switzerland, most of the regulations related to vaccines are contained in the Federal Act on Controlling Communicable Human Diseases (EpidA; Epidemiengesetz, EpG, SR. 818.101) and in the Federal…

Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What is the definition of a vaccine in your country? Danish legislation refers to the definition found in the European Pharmacopoeia.    2. What are the classifications of vaccines in your country? Vaccines are classified as medicines. The…

Join industry executives in staying informed on the market access and HTA process in Romania.  1. What is the definition of a vaccine in your country? The Health Law classifies vaccines as immunological medicinal products (any medicinal product consisting of vaccines, toxins, serums or allergenic products).   2. What are the classifications of vaccines in…

Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate the immune system to produce…

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 (cellular and humoral) mechanisms of…