Frequently asked questions

Article 49 of the Medicines Act obliges marketing authorisation holders to report the availability of a medicine on the Dutch market and supply interruptions.

Suspensions of marketing must be notified without delay, but in any case two months before the marketing of a medicinal product is interrupted. Additional information about the period of the interruption has been clarified in a policy measure.

It must be reported when part or all of the ordered medicines cannot be supplied by the marketing authorisation holder for a period of at least 14 days. If it concerns multiple RVG numbers, a separate notification must be made for each RVG number.

This qualification does not alter the fact that if a marketing authorisation holder for a specific medicine estimates that even a short interruption could have a major impact on the care of patients, the marketing authorisation holder has a moral obligation to report this as quickly as possible.

You only report to the notification centre at the level of pharmaceutical form and strength. You therefore do not have to report if it concerns only one (or part) of the packaging forms/packaging sizes from a group with the same pharmaceutical form and strength if the demand can be met with the other packaging forms/packaging sizes within the same RVG-number.

Yes, a supply interruption is expected. See also the answer to question 1. Please indicate in the notification that the supply interruption may possibly be overcome by other parties.

No, there is no supply interruption as long as you can bridge this interruption with your own stock of the same medicine (same RVG). You do not have to report this situation. See also the answer to question 1.

Yes, if you cannot meet the demand from wholesalers/pharmacies for a period of at least 14 days, this is a situation that you must report. See also the answer to question 1.

You can submit a new notification with the risk-assessment indicated ‘high’. Changing the previously made risk classification within the same notification is currently not possible.

Yes, the new marketing authorisation holder must report this to the notification centre as a supply interruption. The product is currently on the market and if this is not continued by the new marketing authorisation holder, there will be an interruption of the medicinal product's market presence.

Yes, supply interruptions of products with a central marketing authorisation must be reported to both the EMA and the Medicine Shortages and Defects Notification Centre.

Your notification will be processed by the MEB; the MEB or the IGJ may contact you. This depends on the notification.

The MEB investigates the notification of the medicine and carries out an impact analysis to determine whether the medicine is classified as critical. The criteria drawn up by the European Medicines Agency are applied. The MEB looks at the use of the medicine and the availability of alternatives in the Netherlands. The size of the patient group that would be affected is also taken into account.

If the impact analysis shows that there is a threat of a shortage of a critical medicine, the options for a solution will be further investigated.

If the marketing authorisation holder has submitted a request for temporarily different packaging when reporting to the notification centre, the marketing authorisation holder will be notified of this by the MEB.

Another possible solution for a temporary shortage may be that the Health and Youth Care Inspectorate (IGJ) temporarily gives permission to manufacturers, wholesalers or pharmacists to obtain a comparable medicine from abroad. Other solutions can be found on the MEB website.

Your notification will be processed by the MEB; the MEB or the IGJ may contact you. Even if you do not receive a message, you can assume that your report has been processed. You will not receive a message about every notification.

For questions about your notification of a supply interruption, please send a message to tekortendefecten@cbg-meb.nl. 

In case the quality defect is similar for all products and have the same origin, you can combine the notifications. In the section about the concerned product you enter only one medicinal product and mention the other ones later, for example in the text box for summary of the case.

Marketing authorisation holders are responsible for reporting a quality defect in case Dutch batches are or may be impacted. In addition, manufacturers located in The Netherlands (also site of batch release) and responsible for the quality defect should also notify if only non-Dutch batches are impacted. This is also applicable in case of a serious GMP issue with a potential risk for batches on the market.

No, this is not necessary. The EMA will inform the IGJ if also Dutch batches are involved or if the responsible manufacturer (also site of batch release) is located in The Netherlands. The EMA is responsible for communication with member states and company.

Parallel distributors must notify both the EMA and the IGJ if the parallel distributor is responsible for the quality defect. To notify the IGJ please use the Dutch notification form.

If market actions are concluded (for example recall), then the IGJ will contact you. We will first assess the necessity and feasibility of the recall in The Netherlands.

If you request for batch release and this is supported by the European assessor, please contact the IGJ via e-mail (meldpunt@igj.nl) with reference to the EMA notification number (QD-number).

A notification must be submitted within 24 hours after confirmation of the quality defect, complying with the GMP. This aids the IGJ to assess the urgency and need for market actions in a timely manner.

Maybe not all documents and reports have been finished yet. That is fine, these can follow later. If you have not received any e-mail from IGJ yet, you can send these documents to meldpunt@igj.nl with reference to the notification number (MPTD followed by 6 digits).

You can estimate the dates, or choose the first day of the month for example. If it concerns a period, then choose the first day of that period.

The IGJ uses the same categories as used by the EMA. These are similar to the MedDRA terminology. The guidance on notifications, published on the EMA website, contains examples.

Please fill in only a summary. A reference to an attached document only is not allowed. The summary provides the IGJ an quick overview of the nature of the notification and aids the IGJ in a first assessment of urgency and risk.

The IGJ starts to assess the urgency of the quality defect notification. Subsequently, the content, including the risk, is assessed. Also the need of a recall is assessed.

In case the IGJ is Supervisory Authority of the manufacturer where the defect occurred, the GMP components as root cause analysis and CAPA are assessed in detail. If required, other organisations, like the MEB, are consulted.

The assessment including a list with questions is shared with the company. Depending on the urgency a response is usually expected between 1-5 working days.

The IGJ ensures that an inspector processes the notification within 3 hours after submission. The first step is the assessment of the urgency.

In case of a serious quality defect the inspector contacts you within 24 hours. In other cases this is within 5 working days.

If you have additional information in advance, you can send this to the IGJ. See also the answer to question 4.

If an IGJ inspector already contacted you before, you can ask this inspector, for example via previous e-mail in the correspondence e-mail string. The mail box is read continuously at working days, also in case of absence of the inspector.

If you haven’t received an e-mail yet, please send your question to the contact center of IGJ (meldpunt@igj.nl or Telephone +31 88 120 5000) with reference to the notification number (MPTD followed by 6 digits).

First submit a notification of the quality defect and fill in you propose a recall. Subsequently, IGJ assess whether a recall is possible, for example if no shortages are expected. The IGJ also determine

the recall level. We will provide you with our assessment as soon as possible up to several days in cases a meeting is required to discuss the recall.

In cases of very serious patient’s risk, you initiate the recall first and submit the notification immediately hereafter. If you’d wish, please feel free to contact us directly via Telephone +31 88 120 5000).

Choosing one of the notification types for shortages, select option 4 ‘GMP or GCP issues preventing batches from being released to the market’ of the question about the main cause for

discontinuing or interrupting the marketing of the product. A question follows about request of batch release.

If you first use the notification form for quality defects you can fill in the text box ‘Which actions have you planned or do you propose to take?’ The IGJ subsequently assess your proposal. Though, we do not grant permission for batch release, since it is the responsibility of the QP. Instead, we state that we have no objection against release. The final decision has to be made by the QP.

Requests for batch release for centrally authorized products follow a different route. The EMA is in charge to coordinate the assessment. If the assessment concludes that batches may be released, the EMA will ask you to contact the local competent authority. If applicable, you can e-mail the contact center of the IGJ (meldpunt@igj.nl) with reference to the QD-number of the EMA.

This is a notification about an ATMP which does not comply with the specification (out-of-specification (OOS)). According to the GMP for ATMP’s, paragraph 11.5, an OOS ATMP batch may be administered to a patient by exception.

In case of a registered ATMP, marketing authorisation holders or manufacturers must submit a notification. In case of a non-registered ATMP, manufacturers or sponsors (if it applies a clinical study) must submit a notification.

For both registered and non-registered ATMPs the IGJ must be notified. In case of a registered product the notification must also be submitted to the EMA. If the ATMP is part of a clinical study, please also inform the CCMO.

You must submit the notification within 48 hours after the OOS ATMP was administered to the patient on request of the treating physician (earlier notification is allowed).

The IGJ checks whether all required information is included in the notification, assesses the risks of the OOS and registers all notifications. No feedback on the conclusions is provided.

In case of previous contact with an inspector about the notification you can ask your question directly to that assigned inspector. In case of contact by e-mail, please reply to that e-mail. The e-mail box is read regularly during business hours, also in case the assigned inspector is not present.

If you have not had contact before about the current notification, please send an e-mail to atmp@igj.nl. 

You can change the details of the authorised contact person via the Authorised contact person registration form.

A number of the details are registered twice; you have access to such details via the ‘change personal details’ button located at the bottom right of your screen when you are logged in. It is essential that you synchronise the information at both locations and keep it up to date.

If you are registered as both a notifier and the authorised contact person, you can change the details using the Notifier registration form.

The present authorised contact person can change their details to the successor, if necessary. When this person is no longer employed by the marketing authorisation holder, the best action to take is to contact beheerformdesk@cbg-meb.nl and notify them of the intended new authorised contact person (and who will act as their substitute from now on). If the authorised contact person has previously appointed a substitute, the substitute must submit said request by stating the full name and email address. Upon receipt, the change will be effected and you will be further informed by email.

You can add a new notifier account using the Notifier registration form. Select ‘nieuw formulier toevoegen’ to register a new notifier.

You can change the details using the Notifier registration form.

No, you cannot. Only the authorised contact person can change the notifier details at your request. The authorised contact person will previously have received the relevant link in the message confirming receipt after they registered as the authorised contact person.

You can only change your password by using the ‘forgot my password’ option on the notification form.

Please contact beheerformdesk@cbg-meb.nl. The login details will be sent to the email address known to us.

The required minimum number of characters has been changed to 12. To ensure password complexity, 3 of the following 4 types of characters must be used: uppercase letters, lowercase letters, numbers and/or symbols.

The new password will remain valid for 180 days. Any login attempt after said period will require you to enter a new password.

The system will block the relevant IP address for 5 minutes after 10 unsuccessful login attempts.

The system will not accept reused passwords or passwords with only minimal changes.

To ensure better security, we have implemented a more stringent password policy. If your present password no longer meets the new, more stringent requirements, you must change your password. That is why you received this notice. If you attempt to log in and your password no longer meets the requirements, you will only need to change your password once.

The username is filled in automatically; make sure the username is not changed. The new password must be filled in twice before clicking on ‘Send’.

Notifications submitted before 25 October 2024 can be viewed within version 3 of the notification form.

For questions about accounts with the Notification Centre, please contact beheerformdesk@cbg-meb.nl.