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1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which conditions are listed in Article…
22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the counter medications and other medicinal products? See answer to Chapter 1, question 3.   23. What is the authorization process for the marketing of generic versions of these products? To obtain a marketing authorization for generic drugs, an…
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.   1.2. What are the…
 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, “NOMA”), has…
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 NHS, and the central and…
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3.   2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question 6.   3. What are…
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In principle, the regulatory framework set out in the previous Chapters applies. However, differing requirements or procedures apply for specific types of medicinal products. The Medicines Act distinguishes several types of medicinal products, including homeopathic medicinal products and herbal medicinal…
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 public healthcare facilities, clinics, hospitals,…
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 local Authorities published guidelines surrounding…
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 risk of expenditure on innovative…