Articles
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…
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 by Decree-Law No. 97/2015 of…
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…
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…
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
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…
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 established the provisions applicable to…
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…
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…
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…
