Application Form for the Change of Authorisation conditions for Plant Protection Products authorised through Mutual Recognition and as a concerned Member State (cMS)
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Application Form for the Change of Authorisation conditions for Plant Protection Products authorised through Mutual Recognition and as a concerned Member State (cMS)

FORM DETAILS

Applications will not be considered valid unless this form is duly completed and all correct documents and 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.

DETAILS OF PRODUCT
(This question is mandatory)
Product name
(This question is mandatory)
MCCAA Authorisation number
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 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)
Contact person
DETAILS OF APPLICATION
(This question is mandatory)
Type of Application
Kindly refer to the details provided in Annex I for more information on the necessary documents to be submitted in line with the respective change.
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
Full name
Address
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.
Telephone no.
Mobile no.
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 (IF APPLICABLE)
(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.
(This question is mandatory)
Mobile no.
(This question is mandatory)
Contact person
CHANGE IN CHEMICAL COMPOSITION - CURRENT AUTHORISED CHEMICAL COMPOSITION OF PLANT PROTECTION PRODUCT
Active Ingredient(s)
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Co-Formulant
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CHANGE IN CHEMICAL COMPOSITION - NEW CHEMICAL COMPOSITION OF PLANT PROTECTION PRODUCT
Active Ingredient
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Co-Formulant
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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 authorisation conditions of label
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Remove authorisation conditions of label
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Modify authorisation conditions of label
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CHANGES IN PACKAGING
(This question is mandatory)
Would you like to add or remove packaging details?
Add packaging details
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Remove packaging details
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3
CHANGES IN MANUFACTURING SITES
(This question is mandatory)
Would you like to add, remove or modify the manufacturing sites details?
Add manufacturing sites details
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Remove manufacturing sites details
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Modify manufacturing sites details
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OTHER ADMINISTRATIVE CHANGES
(This question is mandatory)
Would you like to add, remove or modify any administrative details?
Add administrative details
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Remove administrative details
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Modify administrative details
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COMPULSORY DOCUMENTATION

For each application form, kindly submit:

  • A cover letter, addressed to MCCAA, justifying the requested changes
  • Proof of payment relevant to this application form

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.

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 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 Chemical Composition:

  • Authorisation Document issued by the reference Member State authorising the change;
  • A signed document with revised chemical composition of the 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 Safety Data Sheets (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 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 Safety Data Sheets (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 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 Packaging, Manufcaturing 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).
Kindly attach any relevant documents (you may opt to compress all files into .a rar file not larger than 10MB)
 Upload files

Use this option to:

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

PAYMENT DETAILS
Payment of €100 has to be effected prior to the submission of the application through
(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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