Withdrawal of authorisation

Withdrawal by authorisation holder

Legal basis

The legal basis of withdrawals by the authorisation holder is article 45, Regulation (EC) no 1107/2009.

Characteristics

Authorisations can only be withdrawn by the authorisation holder itself.

Derived authorisation

If the original product is linked to a derived authorisation, the authorisation holder of the original authorisation must inform the authorisation holder of the derived product, because the authorisation holder of the derived product must also send an application for a withdrawal.

Parallel authorisation

If the original product (also called “reference product”) is linked to a parallel authorisation, the parallel authorisation will remain valid. The parallel authorisation will elapse on the date when the authorisation for the reference product would have normally elapsed.

Registration process

Authorisation holders can withdraw their authorisation or authorisation by sending form WI to the Ctgb. We aim to handle this application within 8 weeks.

Grace periods

See our information about grace periods.

Decision

We send the decision by mail. Do you not agree with the decision we have made, then you can make an objection. How? See Objection and Appeal.

Fees

Withdrawals are not charged.

Instruction for submission

With form WI you can withdraw the authorisation. The application dossier can be submitted digitally by using an upload link (request through post@ctgb.nl ) or by sending a CD or DVD with the information to our postal address. Digital signatures on application forms and Letters of Access are accepted. It is possible to submit part of the dossier on paper and part digitally. Signed documents such as application forms and Letters of Access can be submitted in original paper version by sendiing to our postal address. However we request you to send all other parts of the dossier digitally (either by uploading or by sending a CD or DVD).

For this type of small applications, please don’t send a cover letter.

Withdrawal by authority

Legal basis

The legal basis of withdrawals by the authority is article 44 of Regulation (EC) no 1107/2009.

Characteristics

Member States may review (and withdraw) an authorisation at any time where there are indications that the requirements are no longer satisfied.

If the original product (of a derived authorisation) or reference product (of a parallel authorisation) has been withdrawn by the authority (article 44), the permit holders of the linked permits must send an application to withdraw their permit.

Derived authorisation

The authorisation holder of the original product is responsible that the authorisation holders of the linked derived authorisation are informed to send a withdrawal application to the Ctgb.

Parallel authorisation

The authorisation holder of the parallel authorisation must check itself regularly if the authorisation of the  reference product is still authorised. If the reference product is withdrawn by the authorised authority, the must send a withdrawal application to the Ctgb, to withdrawal their permit.

The authorisation holders become the same grace period for disposal, storage, placing on the market and use of existing stocks as the original/reference product.

Instruction for submission for withdrawal authorisation.

With form WI you can withdraw the authorisation.

The application dossier can be submitted digitally. This can be done either by uploading ( please request an upload link through post@ctgb.nl ) or by sending a CD or DVD with the information to Ctgb’s postal address ( as mentioned on our contact page). Digital signatures on application forms and Letters of Access are accepted.

It is possible to submit part of the dossier on paper and part digitally:

Signed documents such as application forms and Letters of Access can be submitted in original paper version. These can be sent to Ctgb’s postal address ( as mentioned on our contact page).

However we request you to send all other parts of the dossier digitally : either by uploading ( please request an upload link through post@ctgb.nl ) or by sending a CD or DVD with the information to Ctgb’s postal address ( as mentioned on our contact page).

For this type of small applications, please don’t send a cover letter.

Decision

We send the decision by regular mail. Do you not agree with the decision we have made, then you can make an objection. How? See Objection and Appeal.