cbg-portal
The Dutch Medicine Evaluation Board (MEB; CBG in Dutch) has
developed a portal that applicants for marketing
authorisations and marketing authorisation holders can use to
electronically access (via the internet) important information
about the progress of procedures.
The portal offers the marketing authorisation holder the
following information of its own medicinal products:
- An overview of open and/or recently closed submissions of
applications and changes (variations)
- A detailed overview per submission, including data on the phase
the process is in, the MEB employee/case manager currently handling
the submission and data on the medicinal products that are linked
to the submission.
User management has largely been outsourced to the relevant
marketing authorisation holders. Using the so-called CBG Identity
Management System, a single person within the organisation (the
company administrator) is given access and administration rights to
grant other users access. The MEB plays a supporting role in this
process.
A great deal of attention has been paid to securing the information
displayed.
Obtaining initial access to the CBG portal
In order to gain access to the CBG portal, send the completed
and signed application form to the MEB together with
the requested enclosures. The application form must be signed by
the same person listed in the Chamber of Commerce registry. A
copy of a recent excerpt from the Chamber of Commerce registry
(no older than six months) must be enclosed.
Please consult the related application instructions for help
filling out the application form.
The CBG portal administrators will subsequently create a group
for the marketing authorisation holder with the organisations
linked as requested. They will then send a letter to the applicant
with a temporary access code for the CBG portal.
Once the MEB receives the required information, a single person
within your organisation is given the authorisation to create and
manage other user accounts in the Identity Management System.
Adding other organisations to the group account
Multiple, closely allied marketing authorisation holders can be
treated as a single organisation in the CBG portal. This allows you
to view all submission data for all related organisations - mother,
daughter or sister – in a single overview within the CBG portal.
Mutual approval is required from all involved organisations/legal
entities. In order to allow this, you must complete the
relevant application form for each of
the organisations you wish to add. You can fill out the
application forms for the multiple, closely allied marketing
authorisation holders together and submit these to the MEB.
Please consult the related application instructions for help in
filling out the application form.
Contact
Portal employees may be contacted by e-mail: Portal@cbg-meb.nl. If you prefer to
telephone, call the general service desk on +31 88
2248400.
