Reporting new information on authorisation
The authorisation holder has a legal obligation to report Ctgb immediately about indications of harmful or unacceptable effects concerning the specified plant protection product, the active substance or its metabolites, a safener, synergist or co-formulant.
Two types of notifications : immediate and annual notification
Authorised plant protection products are safe to use by following the instructions for use. The authorisation holder has a legal obligation to report Ctgb immediately about indications of harmful or unacceptable effects which suggest that the plant protection product (and its components) no longer complies with the legal authorisation criteria. The authorisation holder of a plant protection product has a legal obligation to notify the Ctgb annually about whether they possess information that the continued efficacy of the product is below expectations, about development of resistance and about any unexpected effect on plants, plant products or the environment.
Assessment of submitted data
The zonal process applies for the assessment of the submitted data. The data will be evaluated in the member state which first granted an authorisation. The evaluation can point out a withdrawal or an amendment of the authorisation is necessary.
When the evaluation of the submitted date a leads to withdrawal or amendment of the authorisation, the evaluating member state will inform other member states in the zone. Basically, the authorisation holder is responsible to arrange that the authorisation meets the criteria of article 29 of Reg. (EC) no 1107/2009. When a change or withdrawal of the authorisation is not actively requested by the authorisation holder, the competent authority has to arrange the authorisation will meet the criteria, by amending or withdrawing the authorisation.
Amendment or withdrawal of authorisations
For the amendment or withdrawal of the authorisation an 'article 44' (Regation 1107/2009) procedure is followed. This means:
- a member state that intends to withdraw or amend an authorisation, informs the authorisation holder;
- the authorisation holder is given the opportunity to provide further information and / or comments;
- the authorisation will be amended or withdrawn where:
- the requirements referred to in Article 29 are not or are no longer satisfied;
- false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
- a condition included in the authorisation has not been met;
- on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
- the authorisation holder fails to comply with the obligations resulting from this Regulation.
- MS immediately informs authorisation holder, other MS’s, EU-commission, EFSA about the amendments or withdrawal;
- a grace period can be granted, where appropriate.
The Member State can also conclude that the criteria for the approval of the active substance, safener or synergist are no longer met. (Or: in case of a co-formulant: MS can consider the co-formulant to be no longer acceptable. In that case it is proposed to withdraw the approval of amend the conditions.)
About any information available to the authorisation holder concerning lack of efficacy, development of resistance and any other unexpected effects of plants / plant products of the environment, the authorisation holder is obliged to report annually to the competent authorities of the Member States.
Immediate Notification by Authorisation Holder
Form for immediate reporting information about potentially harmful or unacceptable effects indicating that the active substance ...
Annual Notification by Authorisation Holder
Form for the annual notification on expected continuation of efficacy, development of resistance and any unexpected effect on ...