New reporting process for the Medicine Shortages and Defects Notification Centre
With effect from 1 January 2022, the Medicines Evaluation Board and the Health and Youth Care Inspectorate will be introducing changes in the procedure for submitting notifications via the Medicine Shortages and Defects Notification Centre. These changes are necessary to improve the security and user-friendliness of the notification centre.
Update of 15 December 2021
Due to unforeseen circumstances, the timetable for the new notification process has changed. This change means that the deadlines have moved. The new timetable is as follows:
To enable this change, accounts will be used. We therefore request to assign one contact person per marketing authorisation holder. This contact person can subsequently submit account requests on behalf of the marketing authorisation holder.
If you have submitted reports for more than one marketing authorisation holder, please contact them to discuss how you can get an account.
It is possible that you submit(ted) a report for medicines that are not authorised. In this case please appoint an authorised contact person for the organisation that is responsible for the medicine. In this case, please read “responsible firm” instead of “marketing authorisation holder”.
To optimise the security and user-friendliness of the notification process, several changes have been made within the notification centre. In the new notification centre, you can copy existing notifications and request an overview of all notifications. To access the new notification centre, it is important that you or one of your colleagues complete the following steps.
We ask that you complete these two steps by 23 December 2021 in order to have immediate access to the new notification centre as of 1 January 2022.
Step 1: appointing one authorised contact person and a substitute
In the new notification process, all reporting parties must be authorised to submit notifications. It is therefore important that you appoint one contact who can do this. The following details are required:
Please communicate the following details by answering this e-mail or via firstname.lastname@example.org.
- the full name of the authorised contact person
- marketing authorisation holder
- email address (Please note: business email address, not your personal email.)
Within several working days after sending these details, the authorised contact person will receive an e-mail with his/her account details and a link to a registration form.
Step 2: registering new reporting parties within your organisation
The confirmation email will contain a link that allows the authorised contact person to access a form. They can use this form to request accounts for reporting parties via the Medicines Evaluation Board. If the contact person would also like to be able to submit reports, they must register as a reporting party by filling out this request form.
There are several options to choose from when registering new reporting parties.
Choice 1: account type
When registering reporting parties, the contact person for the authorisation holder can choose from three account types:
- Organisation account: the advantage of this account type is that you automatically get a comprehensive overview of all notifications submitted by the authorisation holder. This eliminates the need to keep parallel records.
- Department account: a department account is useful if several departments submit notifications for defects and shortages.
With options 1 and 2, it is possible for multiple people to share the same account and password. This is less ideal from a security standpoint, but each authorisation holder can decide whether or not to allow this.
- Personal account: each person has their own account. The disadvantage here is that users can only see their own notifications and not those made by colleagues.
Each authorisation holder may choose from these three options. A combination is also possible, but then there will be no comprehensive overview at the organisational level. It is not possible to transfer notifications from one reporting party to another reporting party (or their overview) at a later date.
Choice 2: verification
As a marketing authorisation holder, you can choose to set up a verification step for one or more reporting parties. In the verification step, the designated person (i.e. the reviewer) receives an email when a notification is submitted. This reviewer determines when the notification will definitively be sent. If you do not use the verification step, the reporting party will submit the notification directly. The current system includes the verification step by default.
Once you have decided which type of account and verification is needed for each reporting party, the details can be entered via the form.
We recommend completing both steps by 23 December 2021, so that you can make full use of the new notification centre from 1 January 2022. You may also complete these steps at a later date (until 18 February 2022). If you choose to do so, however, bear in mind that you will not be able to use the new features as of 1 January 2022.
NB! For urgent notification of defects you can use the old form until 17 February 2022. After this date, you can send urgent notifications to meldpunt@IGJ.nl pending your request for an account.
If you have any questions about the new procedure, please contact the Medicine Shortages and Defects Notification Centre. We can be reached by telephone at +31 (0)88 120 5000 on working days between 9 am and 5 am. You can also send your questions to email@example.com.