Monitoring the quality and safety of medicines

Marketing authorisation of medicines

Drug companies cannot put a new drug on the market unless it has been evaluated and registered by the Medicines Evaluation Board (CBG). This is called marketing authorisation. You can read more about the marketing authorisation procedure for human and veterinary drugs on the CBG’s website. 

Authorisation of homeopathic remedies in the Netherlands

Only registered homeopathic products may be labelled and sold as medicinal products in the Netherlands. The CBG monitors the quality and safety of homeopathic remedies, but it does not assess their efficacy. Manufacturers may only make medical claims that are based on scientific evidence.

Lareb registers side effects of medication

A lot of research and testing is done before a drug can be used on patients. But sometimes it does not become clear that a drug has unwanted effects until it is being used on a large scale. The Netherlands Pharmacovigilance Centre Lareb registers and investigates reports of unwanted reactions to medicines. If you have experienced side effects after using a medicine, report it to Lareb (in Dutch). You should also report any unexpected interactions with other medicines that you are using. Lareb sends this information to the CBG, which may launch a new investigation into the medicine.

Using medicines safely

The Medicines Act (in Dutch) lays down rules so that medicines are used safely. For instance:

• doctors and pharmacists have to report serious side effects;
• doctors must observe strict rules when prescribing medicines during an online consultation;
• the Healthcare Inspectorate may impose fines for violating the Medicines Act. They can set the penalty themselves, depending on the situation;
• at each pharmacy, one pharmacist bears final responsibility for the dispensing of medicines.

Pharmacists check that medicines are used safely

It is important that people use medication in the right way, especially if they take several different medicines. In order to ensure medicines are used safely, pharmacists adopted a standard procedure for assessing medication in 2015. In a short interview with the patient, the pharmacist checks if the medicine prescribed is necessary and if it is being used correctly. This should result in medication being used more safely, which will also have a positive impact on the patient's health.

The standard procedure for assessing medication is one of the points of the Quality Agenda for Pharmaceutical Care. The Quality Agenda also calls for:

• better pharmacy computer systems;
• greater transparency about medicine prices;
• better negotiations between health insurers and pharmacists.

You can read more about the Quality Agenda for Pharmaceutical Care in the health minister's letter to parliament on the results of inter-authority discussions on the pharmacy sector (in Dutch).

Tackling internet trade in counterfeit medicines

The government wants to put a halt to the trade in counterfeit medicines over the internet, for instance by warning health professionals and the public about the risks of buying medicines online. You can read about the full range of measures in the Policy agenda on counterfeit drugs and medical devices (in Dutch). The Ministry of Health, Welfare and Sport, the Healthcare Inspectorate (IGZ) and customs jointly track down suppliers of fake medicines. The IGZ can impose administrative fines on counterfeit drug suppliers.

Buying medicines over the internet from reliable suppliers

More than half of all medicines offered for sale over the internet are falsified. If you want to order medicines online, do so from an authorised supplier. Only then can you be certain the medicines are safe. As of 1 July 2015, the European logo for authorised online pharmacies and approved retailers is obligatory for all websites that sell medicines legally.

Checking the quality of medicinal cannabis

As its name suggests, medicinal cannabis is a medicine. Doctors may prescribe medicinal cannabis for certain specific conditions.

The cannabis must satisfy the same legal requirements as other medication. The Office of Medicinal Cannabis oversees the quality and distribution of medicinal cannabis.