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The Consumer Health and pharma segments in the Netherlands are expected to witness significant growth over the next years with a broad range of distribution channels. CPC experts expect a significant increase in the Dutch Rx and OTC market, with ex-factory sales reaching EUR 12,2 Billion by 2035. Check out this insightful article to find out more about the Dutch pharma market.
The Dutch Market: A Prime Location for Consumer Healthcare and Rx companies.
The Netherlands presents a compelling opportunity for healthcare companies seeking to expand their business, by registering new.
Several factors contribute to its attractiveness:
- World-Class Infrastructure: The presence of renowned research institutions, a highly educated workforce, and an excellent healthcare system creates fertile ground for innovation and development.
- Innovation-Friendly Environment: The government’s support for innovation, and the country’s central location in Europe, make it an ideal base for biopharma operations.
- Growing Market: Healthcare and medical spending are on the rise in the Netherlands, reflecting a strong demand for new medicines and infrastructure.
This translates to significant opportunities for new entrants and established companies looking to expand.
Registration of drugs in the Netherlands/EU
The process involves applying for authorization through one of four established procedures:
- The National procedure: This is for drugs seeking authorization solely in the Netherlands.
- The decentralized procedure (DCP): This allows for simultaneous authorization in several EU member states.
- The centralized procedure (for a European authorization): This leads to a single marketing authorization valid across the entire EU.
- The mutual recognition procedure (MRP): This leverages an existing marketing authorization granted in another EU country.
Figure 1. Procedures for Drug Marketing Authorization
Receiving the Marketing Authorization
Before a drug can be introduced into the market, it must be authorized (also referred to as receiving marketing authorization) by the Medicines Evaluation Board (MEB), which is part of the Ministry of Health, Welfare, and Sport.
The MEB, which consists of doctors, pharmacists, and scientists, evaluates the drug criteria throughout the EU and is responsible for determining whether a drug requires RX or OTC registration. If a product meets all the necessary criteria, the authorization is granted accompanied by specific conditions and obligations that companies must adhere to.
These conditions for distributing a drug are also overseen by the Medicines Evaluation Board, and are:
- Marketing authorization application: The application is reviewed to ensure the drug meets all safety, efficacy, and quality standards.
- Good Manufacturing Practices: It ensures that products are produced and controlled according to quality standards.
- Clinical trials: Clinical trials in phases I, II, and III must be provided for any application to be submitted.
- Risk Management Plan: It includes strategies for mitigating potential risks that could be associated with a drug.
- Pharmacovigilance system: Companies that are willing to distribute any drug should have a system for monitoring and managing the adverse effects of a drug.
Figure 2. Requirements for Drug Regulatory Authorization
Moreover, the Authorization Contact Committee (ACC) oversees the regulatory framework for pharma products in the Netherlands. The committee is integral to the process of drug authorization, ensuring that medicines meet the necessary standards.
Depending on the chosen registration procedure, obtaining an Rx or OTC license can potentially be achieved within a 14-24-month timeframe, allowing a faster market entry compared to many other regions in the world.
Partnering with a local expert can significantly ease the registration process and ensure compliance with all regulations. Chameleon Pharma Consulting Group would be delighted to support you in entering this promising Dutch market. With the expertise amassed from more than 300 international projects and 21 experts around the world, CPC Group offers:
- Systematic product and country analysis;
- Systematic local partner identification;
- Regulatory and registration assistance.
With a well-established global network and decades-long experience accumulated through numerous successful projects, we can ensure a smooth registration process for your company in the Dutch market.
