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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.

Portal Frequently Asked Questions

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?


What prompted the development of the CBG portal?

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.

How will the CBG portal be opened to the industry?

All marketing authorisation holders may now request an CBG portal account. Previously, access was only possible upon invitation.

How can my organisation gain access to the CBG portal?

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.

How will user management be handled?

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.

Can I add multiple organisations to my group?

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.

How can I transfer an organisation to a different group?

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.

How can I terminate an organisation within my group?

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.

What should I do if my organisation's company administrator leaves?

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.

How can I contact the MEB if I have other questions about the CBG portal?

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.

Who can I contact with questions about the status or data quality of a case?

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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