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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

Trade name / Proposed trade name

Zonal Rapporteur Member State

APPLICANT DETAILS

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.

Full name

Address

Email address

Please check the format of your answer.

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.

Only numbers may be entered in this field.

Mobile no.

Only numbers may be entered in this field.

Contact person

Is the applicant also the Representative in Malta?

DETAILS OF REPRESENTATIVE IN MALTA

Full name

Address

Email address

Please check the format of your answer.

Telephone no.

Only numbers may be entered in this field.

Mobile no.

Only numbers may be entered in this field.

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)

Please upload between 1 and 10 files

Upload files

Use this option to:

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

ACTIVE INGREDIENT 1

Content of active ingredient in % (w/w, g/L) in the technical product

	Active ingredient	CAS Number	Content (% technical)	Content (% pure)
1	Active ingredient	CAS Number	Content (% technical)	Content (% pure)

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.

Is the Letter of Access (LoA) attached with the form?

Choose one of the following answers

Yes
Not necessary - Data matching is available
Not necessary - Data Protection expired

If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access

	Ownership of data on active ingredient
Company name	Ownership of data on active ingredient
Address	Ownership of data on active ingredient
Email address	Ownership of data on active ingredient
Contact no.	Ownership of data on active ingredient
Contact person	Ownership of data on active ingredient

Does the product have another Active Ingredient?

ACTIVE INGREDIENT 2

Content of active ingredient in % (w/w, g/L) in the technical product

	Active ingredient	CAS number	Content (% technical)	Content (% pure)
2	Active ingredient	CAS number	Content (% technical)	Content (% pure)

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.

Is the Letter of Access (LoA) attached with the form?

Choose one of the following answers

Yes
Not necessary - Data matching is available
Not necessary - Data Protection expired

If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access

	Ownership of data on active ingredient
Company name	Ownership of data on active ingredient
Address	Ownership of data on active ingredient
Email address	Ownership of data on active ingredient
Contact no.	Ownership of data on active ingredient
Contact person	Ownership of data on active ingredient

Does the product have another Active Ingredient?

ACTIVE INGREDIENT 3

Content of active ingredient in % (w/w, g/L) in the technical product

	Active ingredient	CAS number	Content (% technical)	Content (% pure)
3	Active ingredient	CAS number	Content (% technical)	Content (% pure)

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.

Is the Letter of Access (LoA) attached with the form?

Choose one of the following answers

Yes
Not necessary - Data matching is available
Not necessary - Data Protection expired

If a Letter of Access is submitted, please fill in the details of the owner who is issued the Letter of Access

	Ownership of data on active ingredient
Company name	Ownership of data on active ingredient
Address	Ownership of data on active ingredient
Email address	Ownership of data on active ingredient
Contact no.	Ownership of data on active ingredient
Contact person	Ownership of data on active ingredient

PACKAGING

Retail packaging size/s in Malta

Please fill in at least one answer

	Packaging Size	Unit (g/kg/mL/L)
1	Packaging Size	Unit (g/kg/mL/L)
2	Packaging Size	Unit (g/kg/mL/L)
3	Packaging Size	Unit (g/kg/mL/L)
4	Packaging Size	Unit (g/kg/mL/L)
5	Packaging Size	Unit (g/kg/mL/L)

PAYMENT

Payment of €3,000 has to be effected prior to the submission of the application through

Payment method used

Choose one of the following answers

Bank transfer
Cheque (payable to MCCAA)
EPOS Machine (available at the MCCAA premises in Blata l-Bajda, Malta)

Bank Account Details

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATIONS

Content Declaration

Check all that apply

I, hereby declare that the details furnished above (including any documents mentioned therein) are true and correct to the best of my knowledge and belief and I undertake to inform the Malta Competition and Consumer Affairs Authority of any changes therein, immediately. In case any of the above information is found to be false or untrue or misleading or misrepresenting, I am aware that I may be held liable for it. I confirm that I have attached all relevant documents with this application form.

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.

Data Protection Consent

Check all that apply

I, hereby grant my consent to the Malta Competition and Consumer Affairs Authority for the processing of my personal data in accordance with the above Data Protection Statement.

Please confirm you want to clear your response?