Articles
58. What are the basic requirements to obtain patent and trademark protection? Patents: The most basic requirements follow from the Norwegian Act relating to patents of 15 December 1967 No. 9 (“the Patents Act”). The Patents Act § 2 stipulate that patent protection may be granted to anyone who has made an invention that…
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…
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…
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…
Portugal Cuatrecasas October 2018
Healthcare Actors and Payers: Portugal
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 are: • Ministry of Health…
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…
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health, Welfare and Sport. The Ministry…
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…
Portugal Cuatrecasas October 2018
Healthcare System and Funding: Portugal
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…
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…
