Pharma Legal Handbook 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…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Price Control 1.1. How does price control at ex-factory prices work in your country? The Ex-Factory Price (“PF”) is defined by CMED upon application by the company requesting drug marketing authorization, in accordance with…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes, but unfortunately only in Portuguese: Proposal Application Guideline. Guideline related to Cost-effectiveness. 2. Have local Authorities published guidelines…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Each product category has its own data requirements, foreseen in specific regulations of ANVISA (which…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Which are the main actors involved in public procurement and tendering? As mentioned in Chapter 2, Question 7, each entity of public administration is able to carry out public procurement and tendering in order…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 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 Generic drugs must have their PF 35% cheaper than the corresponding…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…
Pharma Legal Handbook 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…
Portugal Diabetes is a rising threat to the Portuguese people, the country’s healthcare system, and its economy. Portugal’s National Diabetes Observatory observed that 1.1 million Portuguese people between the ages of 20 and 79.5 (out of a total population of just 10.3 million) were living with diabetes in 2021. This…
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