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Open a Pharmaceutical Company in the Netherlands

Updated on Sunday 05th November 2017

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The Dutch pharmaceutical industry is currently one of the best performing economic sectors in the country. It mainly relies on the production and commercializing of licensed products. Pharmaceutical companies in the Netherlands can distribute generic or brand medication and medical devices. Investors who want to open a pharmaceutical company in the Netherlands must comply with a variety of norms, rules and regulations set forth by the relevant authorities for performing this type of activity. 

Our Dutch company formation consultants can explain the requirements related to setting up a pharmaceutical company.

Producing and commercializing medicines in the Netherlands

The Netherlands is a member of the European Union and the World Trade Organization and it has to observe the legal provisions for human use medicinal products, laboratory supplies, medical supplies and medical equipment. Pharmaceutical companies in the Netherlands have the right to apply intellectual property rights on the manufacturing of generic drugs.

Pharmaceutical manufacturers in the Netherlands perform research and development activities for discovering new active substances, produce pharmaceutical starting materials and package the finished dosage forms. Pharmaceutical manufacturers need to be certified for Good Manufacturing Practice.

Types of pharmaceutical products in the Netherlands

There are two main categories of pharma products which can be sold in the Netherlands. Products issued only based on a medical prescription and over-the-counter goods. The last type does not require a doctor’s prescription and can be sol, for example, in FMCG companies or shops in the Netherlands.

It is the Medicines Evaluation Board which has a decisional power on what is a medical prescribed product and what is not.

It should be noted that all medicines must be accompanies with a leaflet, no matter if they are prescribed or not by a doctor. Also, all Dutch pharmaceutical companies must comply with the Maximum Prices for Medicines Regulation which provides for an upper limit related to the price of the marketed products.

You can also watch our video on how to set up a Dutch pharmaceutical company:
 
 

The marketing authorization for medicinal products

All pharmaceutical products in the Netherlands must obtain a marketing authorization or registration. Medicines are registered using their international non-proprietary name or brand name. Marketing authorization holders are required to provide information about the existing authorization and also provide information about the product, in a summary of product characteristics. When applying for a marketing authorization, the holders must also pay a registration fee.

The duties of the Medicines Regulatory Authority (MRA) in the Netherlands include:

  • - providing the marketing authorization;
  • - inspection;
  • - import control;
  • - quality control;
  • - medicines advertising and promotion;
  • - clinical trials control;
  • - pharmacovigilance. 

Pharmaceutical inspectors in the Netherlands are allowed by law to inspect the pharmaceutical companies and the manner in which they conduct their activities. Pharmaceutical products are usually subject to certain special import and export provisions. 

The Netherlands does not have any duties on imported active pharmaceutical ingredients. Pharmaceutical products are still subject to VAT.

Types of marketing authorizations in the Netherlands

One of the best part about starting a pharma business in the Netherlands is that the company can sell its products within and/or outside the country. Based on this criterion, the pharmaceutical marketing authorization can be divided into:

  • -       a national marketing authorization;
  • -       an European marketing authorization.

Also, the registration procedure of a Dutch pharma company with the Medicines Evaluation Board can be:

  • -       national;
  • -       decentralized;
  • -       centralized;
  • -       mutual recognition process.

The last two procedures refer to Dutch pharmaceutical companies registering and selling their products at national and European levels at the same time. The simplified or decentralized procedure is related to importing pharmaceutical products from EU or EEA countries through a faster process.

Please contact our company incorporation agents in the Netherlands can tell you more about the taxation regime for companies in the Netherlands. We can help you open a pharmaceutical company or invest in other Dutch business sectors

 

 

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