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 Currently there are no policies in place in this regard. b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Please make a general introduction to the public health sector in your country and its organization The Public sector is composed of the National Health Service (Serviço Nacional de Saúde), also referred as the…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1.Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The most relevant administrations, bodies and institutions in charge of public health in Portugal…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Price 1.1. How does price control at ex-factory prices work in your country? Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below.…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The CATS and the DATS are responsible for SiNATS. 2. Do regulators require HTA studies in your country?…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment. The recommendations can be consulted here. 2. Have…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval The data that must be submitted varies according to the type of medicinal product and…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes. Infarmed can choose to enter into managed entry agreements (MEA) with marketing authorization holders to regulate the…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Which are the main actors involved in public procurement and tendering? Within the health sector, public procurement and tendering involve mostly the participation of entities pertaining to the NHS, namely public companies who manage…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Has an essential or priority drug list been published in your country? (If so provide the link) Portuguese health authorities have not approved an “essential medicines list”. However, there’s a list in force in…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. What is the definition of an orphan drug in your country? A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (i) that it is intended for the…
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