Manufacturing

Rules and regulations for your sector

Advertising medicines

If you want to advertise medicines, you must keep to the rules specified in the Medicines Act (Geneesmiddelenwet). It distinguishes between advertising for prescription medicines and advertising for...

Applying for an exemption from the Opium Act

The Dutch Opium Act (Opiumwet) regulates which opioids and other narcotics are banned in the Netherlands. You are not allowed to have these banned substances on your business premises. Furthermore,...

Free-sale certificate

Do you export products to non-EU/non-EEA countries? You may need a free-sale certificate (FSC). What is a free-sale certificate? A free-sale certificate states that the concerned products are...

Permits for working with medicinal products and body material

Do you work with medicinal products, active pharmaceutical ingredients (APIs), blood products, intermediates, body material or tissue? For example, your company is involved in the (whole)sale or...

Putting new medicines on the market

Do you run a pharmaceutical business in the Netherlands and do you want to put a new or modified medicine on the market? You need a marketing authorisation from the Medicines Evaluation Board, MEB...

Reporting side effects of medicines

Do you work with medicines in the Netherlands? You must report serious side effects of registered medicines. The Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG) checks the...

Rules for veterinary drugs and animal feed additives

Do you produce, supply, keep in stock, or administer veterinary drugs in the Netherlands? You must have a marketing authorisation from the Medicines Evaluation Board (College ter Beoordeling van...

Rules on animal testing and research

Are you a scientist, doctor, or veterinarian? And do you want to carry out tests on animals, for instance for vaccine testing? You must comply with requirements regarding expertise, animal welfare,...

Working with radiation

Do you work with ionising radiation? Do you use radiation in your production process, or is it released as a result thereof? This radiation may be harmful to humans, animals, and the environment. You...

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Regulations