Withdrawal of authorisation or permit
There are two types of withdrawals: withdrawal by the authorisation holder and withdrawal by the authority.
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Authorisations and permits can only be withdrawn by the authorisation holder itself.
Derived permit
If the original product is linked to a derived permit, 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 permit
If the original product (also called “reference product”) is linked to a parallel permit, the parallel trade permit will remain valid. The parallel trade permit 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 permit 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 regular 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 / permit. The application must be submitted on paper. (We don’t require a digital version). 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If the original product (of a derived permit) or reference product (of a parallel permit) has been withdrawn by the authority (article 44), the permit holders of the linked permits must send an application to withdraw their permit.
Derived permit
The authorisation holder of the original product is responsible that the authorisation holders of the linked derived permit are informed to send a withdrawal application to the Ctgb.
Parallel permit
The authorisation holder of the parallel permit 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 permit 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 permit.
With form WI you can withdraw the authorisation/permit. The application must be submitted on paper. (We don’t require a digital version). 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.