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Application Form for the Zonal Authorisation of a Plant Protection Product

FORM DETAILS

Applications will not be considered valid unless the application form is duly completed and all correct documents and correct labels have been submitted with this form. Payment has to be effected within 3 days from the submission of this form for the application to be considered valid. It is recommended that proof of payment of the applicable fees is submitted via the upload section available hereunder, otherwise the application will not be processed until payment is performed.

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

DETAILS OF THE APPLICANT

Contact person

Name
Position

Company name

Address

Telephone no.

Only numbers may be entered in this field.

Email address

Please check the format of your answer.

ADDRESS FOR INVOICING

Contact person

Name
Position

Company name

Address

Telephone no.

Only numbers may be entered in this field.

Email address

Please check the format of your answer.

VAT no.

PRODUCT IDENTITY

Product name (or code no.)

Authorisation holder

Company name
Address

Marketing company

Company name
Address

Current authorisation(s)

Active substance(s) and content (list all using common names)

Separate each active substance and content using a semi-colon (;)

Field of use

Choose one of the following answers

Professional use
Non-professional use

TYPE OF APPLICATION (APPLICATION GUIDE)

Tick the box(es) that best describe your application

Choose one of the following answers

New plant protection product
New low risk plant protection product
New use of existing product (on label)
Renewal of authorisation of plant protection product
Change to active substance, technical specification or new active substance manufacturing site
Formulation change
Packaging change
Meeting data submission deadline / outstanding data requirements
Change / new MRL

Evaluation module relevance

	Not relevant	Yes	Comments (if not relevant is selected)
Product background, regulatory context and GAP information (core)	Not relevant	Yes	Comments (if not relevant is selected)
Identity, physical and chemical properties, further information (core)	Not relevant	Yes	Comments (if not relevant is selected)
Efficacy data and information (core)	Not relevant	Yes	Comments (if not relevant is selected)
Analytical methods (core)	Not relevant	Yes	Comments (if not relevant is selected)
Mammalian toxicology (core)	Not relevant	Yes	Comments (if not relevant is selected)
Metabolism and residues (core)	Not relevant	Yes	Comments (if not relevant is selected)
Environmental fate (core)	Not relevant	Yes	Comments (if not relevant is selected)
Ecotoxicology (core)	Not relevant	Yes	Comments (if not relevant is selected)
Relevance of metabolites in GW (core)	Not relevant	Yes	Comments (if not relevant is selected)

Tick the box(es) that best describe your application

Choose one of the following answers

New draft label submitted (and Compatibility Assurance Statement, if necessary)
Use the existing authorised label for this product
Use the existing authorised label of another product

Other authorised product information

Product name
The MCCAA Authorised No.

DATA OWNERSHIP

Active substance name

Is all the data on the active substance owned by the authorisation holder?

If 'no', please specify all ownership below

	Data owner(s)	Enclosed	Refer to previous letter	Not needed - unprotected data	Comments (if not needed - unprotected data)
Specification and 5 batch analysis data	Data owner(s)	Enclosed	Refer to previous letter	Not needed - unprotected data	Comments (if not needed - unprotected data)
Other active substance data	Data owner(s)	Enclosed	Refer to previous letter	Not needed - unprotected data	Comments (if not needed - unprotected data)

FORMULATION DETAILS (ACTIVE SUBSTANCE AND FORMULATION RECIPE)

Tick the box(es) that best describe your application

Choose one of the following answers

Existing product - No change to authorised active substance technical specification(s) / manufacturing site(s) and formulation recipe
Existing product - New active substance manufacturing site(s) or change to technical specification(s) only
Existing product - Formulation recipe change only
New product

ACTIVE SUBSTANCE SOURCE(S) / TECHNICAL SPECIFICATION(S)

Active substance source(s) / technical specification(s)

	1	2	3	4	5
Active substance name	1	2	3	4	5
Manufacturing site	1	2	3	4	5
Site not authorised in another product	1	2	3	4	5
Site authorised in another product (or subject to ongoing application)	1	2	3	4	5
Product name	1	2	3	4	5
Technical specification reference	1	2	3	4	5

FORMULATION COMPOSITION

Type of formulation

Choose one of the following answers

New formulation never previously authorised
Formulation authorised in another product

If 'formulation authorised in another product', please specify below

Product name
The MCCAA Authorisation number & formulation reference

PACKAGING DETAILS

Type of packaging

Choose one of the following answers

All packaging as currently authorised for this product
This is a new product or new packaging that is requested for an existing product

If 'this is a new product or new packaging that is requested for an existing product', please list all packaging required below

	Ranges of sizes	Pack material and design
1	Ranges of sizes	Pack material and design
2	Ranges of sizes	Pack material and design
3	Ranges of sizes	Pack material and design
4	Ranges of sizes	Pack material and design
5	Ranges of sizes	Pack material and design

COMPULSORY DOCUMENTATION

Please ensure that all documentation below, unless stated otherwise, is attached to this form:

Application overview;
Data (not in dossier format);
Draft Registration Report (the dRR should be a standalone document not referring to dRR's involving other products. If any section of the dRR is deemed to be irrelevant, please include the rational in the corresponding document);
List of submitted data;
In the case of authorisation renewal, a list of all studies necessary and available should be included together with a statement of compliance confirming that the product still complies with Article 29 of Regulation 1107/2009/EC;
In the case if authorisation renewal, any claims of Category 4 studies have to be substantiated via submission of documented proof of ongoing studies. A complete study list has to be submitted giving expected study duration, date of completion of such studies together with respective study justification and the expected date of full dossier submission;
A list of studies for data protection in Malta. Please provide the list in '.xls' format as presented here;
Relevant correspondence;
Letter(s) of access;
Compatibility Assurance Statement;
A SDS for the product in accordance with Regulation 1272/2008/EC;
A SDS for each active substance and co-formulant in accordance with Regulation 1272/2008/EC;
Original labels;
Official translation in English (if original is not in English);
Official translation in Maltese (note that if Maltese alphabet is not used, the label [and application] will not be valid).

Kindly attach any relevant documents

Please upload between 1 and 20 files

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:

€35,000 for new plant protection product;
€25,500 for new low risk plant protection product;
€24,000 for renewal of authorisation of a plant protection product;
€8,000 for new use of existing product (on label);
€8,000 for change to active substance technical specification or new active substance manufacturing site;
€8,000 for formulation change (Annex 2 must be completed);
€8,000 for packaging change;
€8,000 for change / new MRL.

Payment has to be effected within 3 days from submission of application

Payment method

Choose one of the following answers

Bank transfer
Cheque (payable to MCCAA)

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 in this application 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, untrue, misleading or misrepresenting, I am aware that I may be held liable for it.

Data Protection Declaration

Check all that apply

The Malta Competition and Consumer Affairs Authority ("the Controller") will process your personal data in accordance with the relevant provisions of the General Data Protection Regulation (GDPR), the Data Protection Act (Chapter 586 of the Laws of Malta) and other regulations made thereunder. The Controller will process your personal data for licensing and administrative purposes and to comply with its legal obligations. For further information on how your personal data will be processed refer to the Controllers's privacy policy.
I, the data subject, hereby consent to having the Malta Competition and Consumer Affairs Authority collect and process my personal information from this application.

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