Application form for the Renewal of Authorisation of a Plant Protection Product Authorised in accordance to Article 40 of Regulation (EC) No 1107/2009
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Application form for the Renewal of Authorisation of a Plant Protection Product Authorised in accordance to Article 40 of Regulation (EC) No 1107/2009

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 application 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.

For more information and guidance on how to fill this form, please click here.

GENERAL INFORMATION
(This question is mandatory)
Product name
(This question is mandatory)
MCCAA Authorisation number
APPLICANT DETAILS
(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
(This question is mandatory)
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
APPLICATION DETAILS
(This question is mandatory)
Application type
(This question is mandatory)
Kindly indicate the type of changes and fill in the relevant sections
CHANGE IN TRADE NAME
(This question is mandatory)
AUTHORISED trade name
(This question is mandatory)
PROPOSED trade name
CHANGE IN AUTHORISATION HOLDER - DETAILS OF NEW AUTHORISATION HOLDER
(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
(This question is mandatory)
Is the new authorisation holder also the representative in Malta?
CHANGE IN AUTHORISATION HOLDER - 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
CHANGE IN CHEMICAL COMPOSITION - CURRENT AUTHORISED CHEMICAL COMPOSITION OF PPP
Active Ingredient(s)
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3
Co-Formulant(s)
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10
CHANGE IN CHEMICAL COMPOSITION - NEW CHEMICAL COMPOSITION OF PPP
Active Ingredient(s)
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3
Co-Formulant(s)
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2
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10
CHANGE IN THE CLASSIFICATION AND LABELLING
(This question is mandatory)
New Classification and labelling under Regulation (EC) No 1272/2008
Classification
(This question is mandatory)
Justification for the change in classification
CHANGE IN AUTHORISATION CONDITIONS OF LABEL
(This question is mandatory)
Would you like to add, remove or modify the authorisation conditions of label?
Add to authorisation conditions of label
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2
3
4
5
Remove authorisation conditions of label
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3
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5
Modify authorisation conditions of label
Old
New
Old
New
Old
New
Old
New
CHANGE IN PACKAGING
(This question is mandatory)
Would you like to add or remove the packaging?
Add to the current packaging
1
2
3
Remove from the current packaging
1
2
3
CHANGE IN MANUFACTURING SITES
(This question is mandatory)
Would you like to add, remove or modify the manufacturing sites?
Add to manufacturing sites
1
2
3
Remove manufacturing sites
1
2
3
Modify current manufacturing sites
Old
New
Old
New
Old
New
OTHER ADMINISTRATIVE CHANGES
(This question is mandatory)
Would you like to add, remove of modify administrative details?
Add administrative details
1
2
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4
5
Remove administrative details
1
2
3
4
5
Modify current administrative details
Old
New
Old
New
Old
New
Old
New
COMPULSORY DOCUMENTATION

In case of NO changes in authorisation conditions of the product during the renewal process:

  • A formal declaration stating that the authorisation conditions of the product and all documentation previously submitted remain unchanged including:
    • Authorisation Document
    • Letter of Access
    • Safety Data Sheets (SDSs) of the product, active substance(s) and co-formulant(s)
    • Registration Report
  • Original label issued by the reference Member State
  • Official translation in English and in Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in Trade Name of the Product
    • ​​​​​​​Updated English and Maltese labels (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in Authorisation Holder
    • Authorisation Document issued by the reference Member State authorising the change
    • Original label issued by the reference Member State​​​​​​​
    • Official translation in  English and Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in Chemical Composition
    • Authorisation Document issued by the reference Member State authorising the change
    • A signed document with revised chemical composition of plant protection product
    • A signed declaration that the product does not contain any unacceptable co-formulants in line with Commission Regulation (EU) 2021/383
    • Updated Registration Report issued by the reference Member State, if available
    • Updated list of studies for data protection in Malta in '.xls' format as presented in Annex II, if applicable
    • Updated SDSs for the product, active substance and/or co-formulants shall be provided, if applicable. The SDSs shall be submitted in accordance with Regulation (EC) No 1272/2008, and shall not be older than 3 years from the submission date of the application form.
    • Original label issued by the reference Member State
    • Official translation in  English and Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in the Classification and Labelling of the Product
    • Authorisation Document issued by the reference Member State authorising the change
    • Updated Registration Report issued by the reference Member State, if available
    • Updated list of studies for data protection in Malta in '.xls' format as presented in Annex II, if applicable
    • Updated SDSs for the product, active substance and/or co-formulants which resulted in the change of classification. The SDSs shall be submitted in accordance with Regulation (EC) No 1272/2008 and shall not be older than 3 years from the submission date of the application form.
    • Original label issued by the reference Member State
    • Official translation in  English and Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in the Authorisation Conditions of label
    • Authorisation Document issued by the reference Member State authorising the change
    • Updated Registration Report issued by the reference Member State, if available
    • Updated list of studies for data protection in Malta in '.xls' format as presented in Annex II, if applicable
    • Original label issued by the reference Member State
    • Official translation in  English and Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

In case of changes in authorisation conditions of the product during the renewal process:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  1.  In case of changes in the Packaging, Manufacturing Sites and/or other Administrative changes
    • Authorisation Document issued by the reference Member State authorising the change, if available
    • Updated Registration Report issued by the reference Member State, if available
    • Original label issued by the reference Member State
    • Official translation in  English and Maltese (note that if Maltese alphabet is not used, the label and application will not be valid)

Additional Information:

  • The formal signed documentation shall be addressed to MCCAA and submitted both electronically and by post.
  • Sworn translations of the official authorisation documentation and/or original labels may be requested during the course of the evaluation.
Kindly attach any relevant documents (you may opt to compress all files into a .rar file not larger than 10MB)
 Upload files
PAYMENT DETAILS
Payment of €200 to be affected prior to the submission of the application.
(This question is mandatory)
Payment method

Bank Account Details:

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATION AND CONSENT
(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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