Application form for the Authorisation of a Clone Product of an Authorised Plant Protection Product according to Regulation (EC) No 1107/2009 as implemented by S.L. 430.07
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Application form for the Authorisation of a Clone Product of an Authorised Plant Protection Product according to Regulation (EC) No 1107/2009 as implemented by S.L. 430.07

FORM DETAILS

Application will not be considered valid unless this form is duly completed and all correct documents and correct labels are submitted with this form. Payment is to be affected prior to the submission of this form for the application to be considered valid and proof of payment of the applicable fees is to be submitted via the upload section available hereunder, otherwise the application will not be processed.

GENERAL INFORMATION
(This question is mandatory)
Trade name / proposed trade name of clone product
(This question is mandatory)
Type of Plant Protection Product
(This question is mandatory)
If 'Other', please specify
DETAILS OF APPLICANT
(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 1st of May 2022 onwards. If any personal or company details have changed from when you last submitted this form, then 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
Email address
(This question is mandatory)
Telephone number
(This question is mandatory)
Mobile number
(This question is mandatory)
Contact person
(This question is mandatory)
Is the applicant also the representative in Malta?
DETAILS OF REPRESENTATIVE IN MALTA
(This question is mandatory)
Full name
(This question is mandatory)
Address
(This question is mandatory)
Email address
(This question is mandatory)
Telephone number
(This question is mandatory)
Mobile number
(This question is mandatory)
Contact person
DETAILS OF REFERENCE PRODUCT AUTHORISED IN MALTA
(This question is mandatory)
Name of reference product authorised
(This question is mandatory)
Name of authorisation holder
(This question is mandatory)
Name of Active Substance and concentration
(This question is mandatory)
Formulation type
(This question is mandatory)
MCCAA authorisation number
(This question is mandatory)
Expiry date of authorisation
(This question is mandatory)
Authorised packaging sizes (g/kg/mL/L)
DETAILS OF CLONE PRODUCT
(This question is mandatory)
Name of Active Substance and concentration
(This question is mandatory)
Formulation type
(This question is mandatory)
Packaging sizes (g/kg/mL/L)
MANUFACTURING SITES OF THE CLONE PRODUCT
(This question is mandatory)
Manufacturing Site(s) of Active substance
(This question is mandatory)
Manufacturing Site(s) of the Plant Protection Product
COMPULSORY DOCUMENTATION

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

  • A Safety Data Sheet (SDS) for the product in accordance with Regulation (EC) No 1272/2008 and shall not be older than 3 years from the submission of the application form;
  • Formal signed statement that the clone plant protection product is identical to the reference product authorised in Malta;
  • Signed Letter of Access (LoA), if applicable;
  • A signed declaration that the product does not contain any unacceptable co-formulants in line with Commission Regulation (EU) 2021/383;
  • Original product label;
  • Official translation of label in English (if original is not in English);
  • Official translation of label in Maltese (note that if Maltese alphabet is not used, the label and application will not be valid);
  • Proof of payment.

Additional information: The formal signed documentation shall be addressed to MCCAA and submitted both electronically and by post

Kindly attach any relevant documents (you may opt to compress all files into a .rar file not larger that 10MB)
 Upload files
PAYMENT DETAILS

Payment has to be effected prior to the submission of the application of:

  • €500 for plant protection products authorised through Mutual Recognition
  • €3000 for plant protection products authorised as zonal rapporteur Member State in terms of Article 33 of Regulation (EC) No 1107/2009
  • €3000 for plant protection products authorised as concerned Member State in terms of Article 33 of Regulation (EC) No 1107/2009
(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

Data Protection Statement

Personal data provided in your application will be processed by the Malta Competition and Consumer Affairs Authority ("the Controller"), in accordance with the provisions of the General Data Protection Regulation (Reg. 2016/679) and the Data Protection Act (Chapter 586 of the Laws of Malta) for licensing and administrative purposes and to comply with the Controller's legal obligations. Upon approval of your application, the Controller will process your personal data in relation to the purpose for which such data was submitted.

(This question is mandatory)
Data Protection Consent
 

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