Tagged with Netherlands

Alexion Dana Vigier, Regional Vice President at Alexion, AstraZeneca Rare Disease blends clinical training as a French general practitioner with broad pharmaceutical leadership experience. Formerly President of the French Pharma Association in Oncology and a Global Franchise leader at AstraZeneca, she now oversees Alexion’s operations across Central and Northern Europe, including…

Belgium The latest stories from healthcare and the life sciences in Belgium, the Netherlands and Luxembourg (BeNeLux). UCB is considering a USD five billion investment in the US to avoid President Trump’s tariffs on the EU; Belgium’s competition authority fines three consumer healthcare companies; and the launch of a EUR 200…

Netherlands Philip Scheltens, Professor of Neurology and Partner and Head of the EQT Life Sciences Dementia Fund, reflects on the journey from founding the world’s first dedicated neurodegeneration investment fund to building a strong pipeline of promising companies, backed by scientific rigour, biomarker innovation and partnerships with major pharmaceutical firms. With…

Pharma Legal Handbook 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,…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Reform of the Drug Reimbursement System The policy on medicinal products of the Ministry of Health Welfare and Sport is based on three core values: quality, accessibility and affordability. In order to improve the affordability of healthcare,…

Pharma Legal Handbook 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’…

Netherlands The latest news from the Dutch pharma, biotech and healthcare industries, including the bullish comments of Argenx CEO Tim Van Hauwermeiren following the successful launch of its Vyvgart product; cancer diagnostic firm Agendia’s decision to withdraw from a US IPO; and the latest on cross-border travel and vaccines in the…