Articles
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,…
Portugal Cuatrecasas October 2018
HTA Dossiers: Portugal
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…
Portugal Cuatrecasas October 2018
Managed Entry Agreements: Portugal
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…
53. What types of liability are recognized in your jurisdiction? Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal liability. Civil liability can be…
16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical documentation, hereunder results from clinical…
Portugal Cuatrecasas October 2018
HTA Decision Analysis Framework: Portugal
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? Yes, regulators may require HTA…
Norway Simonsen Vogt Wiig May 2024
Marketing, Manufacturing, Packaging & Labeling, Advertising: Norway
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…
Netherlands Houthoff March 2024
Marketing, Manufacturing, Packaging & Labeling, Advertising: The Netherlands
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…
Portugal Cuatrecasas October 2018
Data Requeriments: Portugal
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 the applicable procedure. In any…
1. What types of liability are recognized in your jurisdiction? Dutch liability law generally distinguishes between contractual liability on the one hand and non-contractual liability on the other. Non-contractual liability not only includes fault-based liability (‘onrechtmatige daad‘) but also includes a regime of strict liability for defective products (‘productaansprakelijkheid‘). The regime for strict liability constitutes…
