Articles
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…
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. 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…
Canada Fasken October 2018
Bill 15: The Quebec Government Wants to Limit the Specific Medical Necessity Measure
On March 29 2023, the Quebec Health Minister (the “Minister”) introduced Bill 15, an Act to make the health and social services system more effective (the “Bill”). The Bill, which is still at the detailed study stage, proposes a major renewal of the framework for the health and social services system. Its purpose is to…
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 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. 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. 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…
Netherlands Houthoff March 2024
Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: The Netherlands
Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In principle, the Dutch Opium Act (Opiumwet) (“DOA“) prohibits selling or warehousing, as well as manufacturing, preparing, processing, delivering, dispensing and transporting of products included in ‘List I‘ and ‘List II‘ of the DOA. This includes cannabis: the product ‘hemp’ is included in list II…
1. What are the basic requirements to obtain patent and trademark protection? Patents The three main criteria for obtaining patent protection are novelty, inventive step and industrial application (Article 2 Dutch Patent Act (Rijksoctrooiwet 1995), “DPA“). Trademarks The basic requirements for obtaining trademark protection are that of a distinctive character of the sign, a…
