Please ensure that all documentation below, unless stated otherwise, is attached to this form:
- Original labels;
- Official translation in English (if original is not in English);
- Official translation in Maltese (note that if Maltese alphabet is not used, the label [and application] will not be valid);
- If applicable, a list of studies for Data Protection in Malta should be provided in '.xls' format as presented in Annex II;
- SDS for the product in accordance with Regulation 1272/2008/EC as applicable;
- SDS for each active substance and co-formulant in accordance with Regulation 1272/2008/EC as applicable.
In case of changes in the chemical composition of the product:
- Signed document with revised chemical composition of product plant protection (it is required that the signed document is submitted by post);
- SDSs of revised product in accordance with Regulation 1272/2008/EC;
- Updated registration report.
In case of changes in final classification and labelling:
- Updated SDSs in accordance with Regulation 1272/2008/EC, of active ingredient and / or co-formulant which resulted in the change of classification;
- Updated registration report.
In case of changes in changes in authorisation conditions of label, changes in packaging, and / or changes in manufacturing sites:
- Updated registration report.
Note: SDSs for active ingredient, co-formulants and final product should be submitted if any of those originally submitted have been updated.
If authorisation of the product is through Mutual Recognition, and authorisation document by reference Member State authorising the change is required.