The pharmaceutical industry in the Netherlands deals with the production and marketing of licensed medicinal 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.
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.
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;
- import control;
- quality control;
- medicines advertising and promotion;
- clinical trials control;
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
The Netherlands does not have any duties on imported active pharmaceutical ingredients. Pharmaceutical products are still subject to VAT