Reporting a quality defect and recalls

Reporting quality defects

The company concerned (usually the marketing authorisation holder) can file a report with the Medicine Shortages and Defects Notification Centre. This report then goes to the IGJ and the Medicines Evaluation Board (CBG). The IGJ takes up the report. An inspector immediately assesses the public health risk and provides initial feedback to the company within a maximum of 5 days.

Other parties, such as pharmacies and wholesalers, can also file a report if they suspect a quality defect. You can find more information about this at the website mentioned above.

Recall by marketing authorization holder

Sometimes a medicine has to be recalled from the market urgently. Whether a recall is necessary depends on the risk. Depending on the risk, the recall takes place at:

• patient level
• pharmacy level
• wholesale level

In most of the reported cases there is no need for a recall. The risk to the patient is not serious. It may be important to keep the medicine available. That is a decision to be made by the inspectorate.

A recall may be deployed by the marketing authorization holder only after coordination with the IGJ. The first step is to file a report with the IGJ. Only in very serious cases may it be necessary to take immediate measures to protect the patient. In that case, the recall comes first and a report with the inspection must follow immediately after.

The IGJ does not carry out the recall itself. This is a task of the marketing authorization holder. The corresponding recall notice must be coordinated with the IGJ. The IGJ has published recalls on this website since 1 October 2024. It concerns the pharmacy and patient level recalls that apply to all pharmacies.

Sending a recall message

Since 1 October 2024, a recall message is sent via e-mail as far as possible according to the procedure with the Orange Hand (in Dutch). Only healthcare providers whose e-mail address is not available will still receive the recalls by post.

Read more about this change in the news release Quicker crisis communication to healthcare providers (in Dutch) on the CBG website and in the frequently asked questions about the digital recall messages (in Dutch).

Recall report

After the recall is dealt with, a recall report must be made. We expect this report within 8 weeks of the deployment of the recall. The recall report must include the following elements:

• Chronological overview of steps taken
• Assessment: reconciliation (overview of packaging) and the effect of the recall. Here it must be recorded how many e-mails did not arrive (due to out-of-office or inactive mail address, for example) and what steps have been taken to reach these recipients anyway.
• Review of the recall and any actions taken to improve the recall procedure.

Information for patients   

Are you a patient and do you use a medicine on the recall list? Do you have questions or concerns about the recall? If so, contact your pharmacy. If the IGJ has decided that patients must return their packaging, your pharmacist will let you know. 

The other way around is also true: if, as a patient, you did not receive notice from your pharmacist to return your medicine, that means that the IGJ decided that the risk to patients is not serious enough for that. In such a case, it would be more harmful for you to have no medicine at all than to have the medicine with the reported defect.