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…
Europe Drawing from the 2021 edition of the EFPIA’s comprehensive annual data review of the European pharma industry, we present the Top 5 countries across a variety of pharma metrics: from market size to R&D spend, production, exports, imports, and generics penetration. Made with Visme Infographic Maker Made with…
Belgium Sabena Solomon, general manager of GSK Benelux, speaks about her first impressions of the Belgium market, having come from GSK Finland, and her initial priorities for leading the affiliate. Solomon goes on to explain GSK’s continued commitment to ensuring patients have access to innovative medicines, the role the company plays…
Belgium Miranda Heining, general manager of Fresenius Kabi for Belgium and the Netherlands, speaks about the career path that led her to join the pharma industry and lead the affiliate, her experience managing two countries simultaneously, and the potential pitfalls in navigating Belgium’s market access landscape. The complexity of the…
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