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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
(This question is mandatory)
Contact person
(This question is mandatory)
Company name
(This question is mandatory)
Address
(This question is mandatory)
Telephone no.
(This question is mandatory)
Email address
ADDRESS FOR INVOICING
(This question is mandatory)
Contact person
(This question is mandatory)
Company name
(This question is mandatory)
Address
(This question is mandatory)
Telephone no.
(This question is mandatory)
Email address
(This question is mandatory)
VAT no.
PRODUCT IDENTITY
(This question is mandatory)
Product name (or code no.)
(This question is mandatory)
Authorisation holder
(This question is mandatory)
Marketing company
(This question is mandatory)
Current authorisation(s)
(This question is mandatory)
Active substance(s) and content (list all using common names)
Separate each active substance and content using a semi-colon (;)
(This question is mandatory)
Field of use
TYPE OF APPLICATION (APPLICATION GUIDE)
(This question is mandatory)
Tick the box(es) that best describe your application
(This question is mandatory)
Evaluation module relevance
Product background, regulatory context and GAP information (core)
Identity, physical and chemical properties, further information (core)
Efficacy data and information (core)
Analytical methods (core)
Mammalian toxicology (core)
Metabolism and residues (core)
Environmental fate (core)
Ecotoxicology (core)
Relevance of metabolites in GW (core)
(This question is mandatory)
Tick the box(es) that best describe your application
(This question is mandatory)
Other authorised product information
DATA OWNERSHIP
(This question is mandatory)
Active substance name
(This question is mandatory)
Is all the data on the active substance owned by the authorisation holder?
(This question is mandatory)
If 'no', please specify all ownership below
Specification and 5 batch analysis data
Other active substance data
FORMULATION DETAILS (ACTIVE SUBSTANCE AND FORMULATION RECIPE)
(This question is mandatory)
Tick the box(es) that best describe your application
ACTIVE SUBSTANCE SOURCE(S) / TECHNICAL SPECIFICATION(S)
(This question is mandatory)
Active substance source(s) / technical specification(s)
Active substance name
Manufacturing site
Site not authorised in another product
Site authorised in another product (or subject to ongoing application)
Product name
Technical specification reference
FORMULATION COMPOSITION
(This question is mandatory)
Type of formulation
(This question is mandatory)
If 'formulation authorised in another product', please specify below
PACKAGING DETAILS
(This question is mandatory)
Type of packaging
(This question is mandatory)
If 'this is a new product or new packaging that is requested for an existing product', please list all packaging required below
1
2
3
4
5
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).
(This question is mandatory)
Kindly attach any relevant documents

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

(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
(This question is mandatory)
Data Protection Declaration