New application for reporting the marketing of medicinal products
New application has been developed to facilitate compliance with obligation of the marketing authorisation holder, pursuant to Article 33 para. 2 of Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the “Medicinal Products Act”), as amended, to notify the State Institute for Drug Control of the launch, interruption, renewal or termination of the marketing of a medicinal product.
Description of the main changes
Login
You can access the application using the authentication certificate that you already use when communicating with SÚKL, for example in REG-13 reporting, stock reporting or MAH11r. Access requests and their management are available at https://pristupy.sukl.cz/.
Overview of sent reports and their editing
The application contains several new features, e.g. an overview of all reports that have been submitted by the logged-in holder is displayed within the application, the holder has the possibility to edit the report himself (e.g. updating the expected renewal date) or to cancel the report completely. The list of reports can be searched and filtered according to various parameters, and the history of changes can be displayed for edited reports.
Renewal schedule
If a medicinal product is flagged as ‘restricted availability’ under Article 33b para. 2 of the Medicinal Products Act, the holder is obliged to complete the interruption notification with information on the action taken to remove the reason for the interruption (hereinafter ‘shortage mitigation plan’). The shortage mitigation plan is part of the new application, which will alert the holder to the need to complete and submit the shortage mitigation plan form for the specific interruption notification. The shortage mitigation plan can also be copied to other medicines with this obligation.
Possibility to report only for own products
Once a certificate is logged in, only the products of that holder are available for reporting. The same applies to the ability to edit and cancel reports already submitted. If a company is authorised to report on behalf of several different holders, the correct certificate must always be selected for login.
Example: A certificate issued for the holder Company ABC Ltd. cannot be used to report medicinal products of the holder Company ABC GmbH, even if the Institute has accepted a power of attorney from the holder Company ABC GmbH authorising the holder Company ABC Ltd. to perform such actions.
Other changes
- notifications with the same data for multiple medicinal products can be sent at the same time within a single notification,
- you cannot send reports whose types do not logically follow each other (you cannot send another interruption after an interruption without a resumption in between, you can only report a launch after a termination, etc.),
- the possibility to send the report type ‘interruption without disclosure’ with the stock status in the ‘sphere of influence’ filled in,
- the possibility to save a report in progress,
- sending e-mail notifications.