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Application Form for the Authorisation of a Plant Protection Product 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.

GENERAL INFORMATION
(This question is mandatory)
Trade name / Proposed trade name
(This question is mandatory)
Zonal Rapporteur Member State
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 22nd of July 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
(This question is mandatory)
Is the applicant also the Representative in Malta?
DETAILS OF REPRESENTATIVE IN MALTA
Full name
Address
Email address
Telephone no.
Mobile no.
Contact person
COMPULSORY DOCUMENTATION

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

  • Authorisation document issued by the zonal Rapporteur Member State (zRMS);
  • A formal statement that the Plant Protection Product (PPP) is identical to that authorised by the reference Member State;
  • Signed Letter of Access (LoA), if applicable;
  • A list of studies for Data Protection in Malta. Please provide the list in '.xls' format as presented in Annex I. Data protection commences on the date when the product is first authorised in Malta, in line with the Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009;
  • 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;
  • SDS for each active substance and co-formulant in accordance with Regulation (EC) No 1272/2008 and shall not be older than 3 years from the submission of the application form;
  • A signed declaration that the product does not contain any unacceptable co-formulants in line with Commission Regulation (EU) 2021/383;
  • Original product labelling;
  • 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);
  • Final Registration Report (Parts A+B+C) supplying the information necessary as required in Article 33(3) or Regulation (EC) No 1107/2009, if available;
  • If the Final Registration Report is not available, the applicant must supply a formal letter stating that the Registration Report in conformity with Regulation (EC) No 1107/2009 will be supplied as soon as available, and that MCCAA may access dRR/fRR directly from CIRCABC at any time.
  • 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.

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

Use this option to:

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

ACTIVE INGREDIENT 1
(This question is mandatory)
Content of active ingredient in % (w/w, g/L) in the technical product
1
(This question is mandatory)
Are all data on the active substance owned by the authorisation holder?
Note: A letter of access has to be supplied whenever the ownership of the data is NOT the same as the applicant.
(This question is mandatory)
Is the Letter of Access (LoA) attached with the form?
(This question is mandatory)
If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access
Company name
Address
Email address
Contact no.
Contact person
(This question is mandatory)
Does the product have another Active Ingredient?
ACTIVE INGREDIENT 2
(This question is mandatory)
Content of active ingredient in % (w/w, g/L) in the technical product
2
(This question is mandatory)
Are all data on the active substance owned by the authorisation holder?
Note: A letter of access has to be supplied whenever the ownership of the data is NOT the same as the applicant.
(This question is mandatory)
Is the Letter of Access (LoA) attached with the form?
(This question is mandatory)
If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access
Company name
Address
Email address
Contact no.
Contact person
(This question is mandatory)
Does the product have another Active Ingredient?
ACTIVE INGREDIENT 3
(This question is mandatory)
Content of active ingredient in % (w/w, g/L) in the technical product
3
(This question is mandatory)
Are all data on the active substance owned by the authorisation holder?
Note: A letter of access has to be supplied whenever the ownership of the data is NOT the same as the applicant.
(This question is mandatory)
Is the Letter of Access (LoA) attached with the form?
(This question is mandatory)
If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access
Company name
Address
Email address
Contact no.
Contact person
PACKAGING
Retail packaging size/s in Malta
1
2
3
4
5
PAYMENT
Payment of €3,000 has to be effected prior to the submission of the application through
(This question is mandatory)
Payment method used

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