Tagged with Port

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…

Pharma Legal Handbook 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…

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…

Portugal Novo Nordisk’s spectacular ascendancy in 2023 has meant that its country managers across the world have had to embrace scrutiny and press coverage like never before.   In its centenary year, the Danish firm’s new generation of obesity drugs supercharged revenues to around EUR 30 billion, a 30 percent hike…

Portugal Luis Abrantes explains how Generis, as one of the leading companies by volume in both the retail and hospital segments of the Portuguese pharma market, serves a huge number of patients in the country. Starting out in 2003 as a family-owned firm, it was then bought out by private equity…