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Application Form for the Authorisation of a Plant Protection Product

FORM DETAILS

Applications will not be considered valid unless the application form is duly completed and all correct documents and correct labels have been submitted with this form. Payment has to be effected within 3 days from the submission of this form for the application to be considered valid. It is recommended that proof of payment of the applicable fees is submitted via the upload section available hereunder, otherwise the application will not be processed until payment is performed.

GENERAL INFORMATION
(This question is mandatory)
Trade name / proposed trade name
(This question is mandatory)
Type of Plant Protection Product
If 'Other', please specify
(This question is mandatory)
Application for
APPLICANT DETAILS (PERMANENT COMMUNITY ADDRESS)
(This question is mandatory)
Are you a returning user?

A 'returning user' is one who has at least filled in this form once, from the 3rd of August 2020 onwards. If any personal or company details have changed from when you last submitted this form, the you are kindly asked to click 'No'. By clicking 'Yes', you are declaring that you have already provided your personal details in this form, and will therefore be asked for the email address only.

If you are unsure whether you are a returning user or not, you may either click 'No' or else contact the MCCAA for assistance.

(This question is mandatory)
Full name
(This question is mandatory)
Address
(This question is mandatory)
Email address
Please ensure that the email address is correct as it will be used for acknowledgement purposes and also to get in touch with you.
(This question is mandatory)
Telephone no.
Mobile no.
(This question is mandatory)
Contact person
DETAILS OF REPRESENTATIVE IN MALTA (IF APPLICABLE)
Full name
Address
Email address
Telephone no.
Mobile no.
Contact person
CERTIFICATE
EU Member States where the product is authorised
1
2
ACTIVE INGREDIENT 1
(This question is mandatory)
Content & tolerance limits of active ingredient in % [w/w, g/l] in the technical product
1
(This question is mandatory)
Active ingredient classification
1
(This question is mandatory)
Is the ownership of data on the active ingredient different from the applicant details?
(This question is mandatory)
If 'yes' please fill in the details of the owner who gave you the letter of access
ACTIVE INGREDIENT 2
Content & tolerance limitsof active ingredient in % [w/w, g/l] in the technical product
2
Active ingredient classification
2
Is the ownership of data on the active ingredient different from the applicant details?
If 'yes' please fill in the details of the owner who gave you the letter of access
ACTIVE INGREDIENT 3
Content & tolerance limitsof active ingredient in % [w/w, g/l] in the technical product
3
Active ingredient classification
3
Is the ownership of data on the active ingredient different from the applicant details?
If 'yes' please fill in the details of the owner who gave you the letter of access
CO-FORMULANT 1
(This question is mandatory)
Co-Formulant information
1
(This question is mandatory)
Co-Formulant classification
1
CO-FORMULANT 2
Co-Formulant information
2
Co-Formulant classification
2
CO-FORMULANT 3
Co-Formulant information
3
Co-Formulant classification
3
CO-FORMULANT 4
Co-Formulant information
4
Co-Formulant classification
4
CO-FORMULANT 5
Co-Formulant information
5
Co-Formulant classifcation
5
CO-FORMULANT 6
Co-Formulant information
6
Co-Formulant classification
6
CO-FORMULANT 7
Co-Formulant information
6
Co-Formulant classification
7
CO-FORMULANT 8
Co-Formulant information
8
Co-Formulant classification
8
CO-FORMULANT 9
Co-Formulant information
9
Co-Formulant classification
9
CO-FORMULANT 10
Co-Formulant information
10
Co-Formulant classification
10
PLANT PROTECTION PRODUCT
(This question is mandatory)
Current classification of product
1
(This question is mandatory)
Results of analysis of product (insert figures of results of analysis)
DL 50 oral rat (mg/kg)
DL 50 dermal rat (mg/kg)
CL 50 inhalation rat (mg/l/4h)
Eye irritation rabbit
Dermal irritation rabbit
Sensitisation
Fish (CL 50 in mg/l)
Daphnia (EC 50 in mg/l)
Algae (LC 50 in mg/l)
Other studies
Notes
Impurities
1
2
3
4
5
REGISTRATION REPORT
(This question is mandatory)
A final Registration Report (Parts A+B+C) supplying the information necessary as required in Article 33(3) of Regulation EC 1107/2009 is to be attached with this form 
Note: If 'no' is selected, applicant must supply a formal letter stating that the Registration Report in conformity with Regulation 1107/2009 will be supplied as soon as available.
PACKAGING
Retail packaging size in Malta
1
2
3
4
REQUESTED DOCUMENTATION

Please ensure that all documentation below is attached to this form:

  • A free sales certificate / marketing authorisation from an EU competent authority;
  • Formal statement that the plant protection product is identical to that authorised by the reference Member State;
  • Letter of access of each active ingredient (in the event that ownership of data on active ingredient is different than applicant data);
  • Signed document with detailed chemical composition of the PPP;
  • List of studies for Data Protection in Malta. Please provide the list in '.xls' format as presented in Annex I;
  • 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;
  • A final Registration Report (Parts A+B+C) supplying the information necessary as required in Article 33(3) of Regulation (EC) 1107/2009 or a formal letter stating that the registration report will be supplied as soon as avialable;
  • 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).
Kindly attach any relevant documents

Use this option to:

- attach any relevant supporting information as noted hereabove in the documentation checklist.
- upload proof of payment.

PAYMENT DETAILS

Payment of:

  • €500 for new authorisation
  • €350 for new authorisation if active substance is approved as low-risk in line with Regulation 1107/2009
  • €200 for renewal of authorisation

Payment has to be effected within 3 days from submission of application

(This question is mandatory)
Payment method

Bank Account Details

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATIONS
(This question is mandatory)
Content Declaration
(This question is mandatory)
Data Protection Declaration