Articles

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…
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…
Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359.   1. Please describe the main cost…
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…
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…
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. 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. 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…
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…
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…