The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. Various stakeholders were involved in the process, including marketing authorisation holders who submit notifications.
The first changes to the notification form are being introduced on Friday 8 October 2021.
- As from 17.00 on Friday 8 October, when opening the notification form, you will be redirected to the amended form. From that moment onwards it will no longer be possible to use the old form for new notifications.
- We kindly request that you do not submit or initiate any notifications of shortages on 7 and 8 October. The Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd, IGJ] will take this into account in its supervisory tasks.
- You will, however, be able to use the notification form on 7 and 8 October to submit urgent notifications of defects.
- We kindly request that you complete ongoing notifications (in other words notifications which have not yet been checked or completed) before 8 October. If that proves to be impossible, you can complete notifications until 17.00 on 5 November. To do so you can use the link you received in an earlier email.
If you have any questions or experience any problems, please contact the Medicine shortages and defects notification centre. We can be contacted by telephone on working days from 09.00 to 18.00 on +31(0)88 120 50 000.
More changes will follow at the end of 2021 and additional information on these changes will be provided in due course.
Deleted questions
- The company's address details
- The questions relating to alternative medicinal products not being the company's own medicinal products (or those of an affiliated company within the EU).
Textual changes in questions
- The question regarding the market share has been amended (made more specific and therefore more relevant).
- The questions relating to the availability of alternative medicinal products on the market have been amended (made more specific and therefore more relevant). The answer 'Unknown' is no longer an option.
Added questions
- “Do you wish to request permission to temporarily supply a medicinal product in a different packaging?”
- “Do you intend to withdraw the marketing authorisation of the medicinal product(s) in the foreseeable future?” This question is asked if a medicinal product becomes permanently unavailable.
Changes to the message confirming receipt
- The company's address details have been removed from the message.
- If the FAO question is asked on the form, it will then be included in the email text.
- The date of submission is now followed by the date format, so that there can no longer be any confusion regarding the day and month (DD-MM-YYYY).
- The submission date has been added to the name of the PDF attachment file which contains the copy of the completed form.