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CBG portal
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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.
What prompted the development of the CBG portal?
How will the CBG portal be opened to the industry?
How can my organisation gain access to the CBG portal?
How will user management be handled?
Can I add multiple organisations to my group?
How can I transfer an organisation to a different group?
How can I terminate an organisation within my group?
What should I do if my organisation's company administrator
leaves?
How can I contact the MEB if I have other questions about the CBG
portal?
Who can I contact with questions about the status or data quality
of a case?
A key reason for developing the CBG portal was the MEB’s desire
to increase the transparency of the (progress of the)
decision-making process. The CBG portal creates more open
cooperation between the MEB and the industry by providing greater
insight into the MEB's methods.
Transparency is impossible without the secure exchange of
sensitive information related to privacy and competition between
the MEB and the industry. The CBG portal addresses this need by
serving as a secure communications channel.
The CBG portal also increases the efficiency of information
processing by shifting the responsibility for providing correct /
complete data to the industry. This allows the quality of
submission data to improve, thus reducing the amount of required
correspondence between the MEB and the industry.
All marketing authorisation holders may now request an CBG
portal account. Previously, access was only possible upon
invitation.
You can request access by completing and signing the
application form. A copy of a recent excerpt from the Chamber
of Commerce registry (no older than six months) listing the name of
the individual whose signature is on the application form must be
enclosed. Please consult the
Guide How To Apply New Group 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.
User management is decentralised using the MEB Identity
Management System. A single individual within the marketing
authorisation holder’s organisation, the company administrator, is
given access and administration rights by the MEB; this person can
in turn create accounts for other users. The company administrator
can give a second user, the so-called proxy administrator,
administration rights for support. The MEB plays a supporting role
in this process. Please consult the
CBG portal Job Aid for Company Admins for help in managing
users.
Yes, adding multiple organisations to a single group is
possible. This can be requested using the ‘
Adding to existing group’ application form. Please consult the
Guide How to Apply Existing Group for help filling out the
application form.
An organisation can be transferred to a different group using
the
Move Organisation form. This form is used in the event of a
merger between organisations, for example, or if an organisation is
split. Upon receiving the form, CBG portal administrator will move
the organisation.
If certain organisation-specific information should not be
displayed to users, an organisation can be removed from a group.
This can be done by completing and submitting the
Termination Form. Upon receiving the form, CBG portal
administrator will terminate the organisation within your
group.
In the event:
- A company administrator leaves an organisation and needs to be
replaced, OR
- If a new individual must be appointed proxy administrator,
replacing the current one the
Modify Administrator form must be filled out.
Please note: the MEB only assigns proxy administrator rights if
the company administrator is unable to do so, for example due to
extended leave. If no proxy administrator has been assigned within
a group, the company administrator is responsible for assigning
these rights to a user.
Portal employees may be contacted by e-mail: Portal@cbg-meb.nl. If you prefer to
telephone, call the general service desk on +31 (0)88 2248400.
There are two links to contact form at the bottom of the 'Case
Details’. Use the ‘Contact your Case Manager’ form if you have
questions about the status of or deadlines for a case. Use the
‘Data Quality Issues’ form if you have questions about a case’s
data quality.
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