Application Form for the Zonal Authorisation of a Plant Protection Product
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Application Form for the Zonal Authorisation of a Plant Protection Product

FORM DETAILS

Application will not be considered valid unless this form is duly completed, and all correct documents and proof of payment are submitted with this application form.

SECTION 1: APPLICATION OVERVIEW
Part 1A: PRODUCT IDENTITY
(This question is mandatory)
Product code:
(This question is mandatory)
Product trade name:
(This question is mandatory)
Function:
(This question is mandatory)
Active substance(s) (incl. content):
(This question is mandatory)
Formulation type:
Separate each active substance and content using a semi-colon (;)
(This question is mandatory)
Application for:
(This question is mandatory)
User category:
Part 1B: APPLICANT DETAILS
(This question is mandatory)
Contact name:
(This question is mandatory)
Company name
(This question is mandatory)
Position within the company:
(This question is mandatory)
Address
(This question is mandatory)
Telephone:
(This question is mandatory)
Email address:
Part 1C: APPLICANT REPRESENTATIVE (IF APPLICABLE)
Contact name:
Company name:
Position within the company:
Address:
Telephone:
Email address:
Part 1D: TYPE OF APPLICATION
(This question is mandatory)
Tick the box that best describe your application
SECTION 2: ACTIVE SUBSTANCE DATA OWNERSHIP
Active substance 1:
(This question is mandatory)
Active substance name:
(This question is mandatory)
Is all the data on the active substance owned by the applicant?
(This question is mandatory)
If NO is selected, please specify whether a Letter of Access is enclosed with this form:
(This question is mandatory)
Letter of Access is attached with this form:
Active substance 2 (if applicable):
Active substance name:
Is all the data on the active substance owned by the applicant?
If NO is selected, please specify whether a Letter of Access is enclosed with this form:
Letter of Access is attached with this form:
Active substance 3 (if applicable):
Active substance name:
Is all the data on the active substance owned by the applicant?
If NO is selected, please specify whether a Letter of Access is enclosed with this form:
Letter of Access is attached with this form:
SECTION 3: Article 33 (NewPPP) & Article 47 (New Low-Risk PPP)

Compulsory documentation

In case of an application for an Article 33 and/or Article 47 dossiers:

  • An application overview (cover letter), signed and addressed to the MCCAA.
  • The MCCAA pre-filled Completeness Check document.
  • Draft Registration Report and associated study reports (finalised, dated and signed).
  • Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
  • A Safety Data Sheet (SDS) for the product, each active substance and co-formulant in compliance with Commission Regulation (EU) 2020/878 amending Regulation (EC) No. 1907/2006 and classification in accordance with Regulation (EC) No 1272/2008. The SDSs shall not be older than 1 year from the submission of the application form.
  • Full (100%) chemical composition for each co-formulant, including a signed statement from the suppliers declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the co-formulants. If this is considered business confidential information for the suppliers, the required information shall be provided directly to the MCCAA on [email protected].
  • A signed statement from the applicant declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the product/formulation.
  • 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 document with the request for confidentiality of data in accordance with Appendix 10 of SANCO/13169/2010 Rev. 11.
  • Letter of Access (if applicable) for active substance and/or product data.
  • Letter of Access and Supply (if applicable) for technical equivalence sources.

Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.

SECTION 4: ARTICLE 33 (LABEL EXTENSION/AMENDMENTS)

Compulsory documentation

In case of an application for an Article 33 (Label Extension/Amendments):

  • An application overview (cover letter), addressed to the MCCAA.
  • The MCCAA pre-filled Completeness Check document (as necessary for the the relevant sections).
  • Relevant Sections of the draft Registration Report and associated study reports (finalised, dated and signed).
  • Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
  • Updated 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.
  • An updated document with the request for confidentiality of data in accordance with Appendix 10 of SANCO/13169/2010 Rev. 11.
  • Letter of Access (if applicable) for active substance and/or product data.

Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.

SECTION 5: ARTICLE 33 (SIGNIFICANT CHANGE IN CHEMICAL COMPOSITION)

Compulsory documentation

In case of an application for an Article 33 (Significant change in composition):

  • An application overview (cover letter), addressed to the MCCAA.
  • Draft Registration Report and associated study reports (finalised, dated and signed).
  • Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
  • A Safety Data Sheet (SDS) for the product, each active substance and co-formulant in compliance with Commission Regulation (EU) 2020/878 amending Regulation (EC) No. 1907/2006 and classification in accordance with Regulation (EC) No 1272/2008. The SDSs shall not be older than 1 year from the submission of the application form.
  • Full (100%) chemical composition for each co-formulant, including a signed statement from the suppliers declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the co-formulants. If this is considered business confidential information for the suppliers, the required information shall be provided directly to the MCCAA on [email protected].
  • A signed statement from the applicant declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the product/formulation.
  • 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 document with the request for confidentiality of data in accordance with Appendix 10 of SANCO/13169/2010 Rev. 11.
  • Letter of Access (if applicable) for active substance and/or reference product data.
  • Letter of Access and Supply (if applicable) for technical equivalence sources.

 

Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.

SECTION 6: ARTICLE 34 (EXEMPTION FROM THE SUBMISSION OF STUDIES)
Part 6A:    Details of the reference product in Malta (fill-in)
(This question is mandatory)
Product name:
(This question is mandatory)
Active substance(s) (incl. content):
(This question is mandatory)
Authorisation holder:
(This question is mandatory)
MCCAA Authorisation number:

Part 6B: Compulsory documentation

In case of an application for an Article 34:

  • An application overview (cover letter), addressed to the MCCAA.
  • Draft Registration Report (Part A, Part B0 and Part C).
  • Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
  • A Safety Data Sheet (SDS) for the product, each active substance and co-formulant in compliance with Commission Regulation (EU) 2020/878 amending Regulation (EC) No. 1907/2006 and classification in accordance with Regulation (EC) No 1272/2008. The SDSs shall not be older than 1 year from the submission of the application form.
  • Full (100%) chemical composition for each co-formulant, including a signed statement from the suppliers declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the co-formulants. If this is considered business confidential information for the suppliers, the required information shall be provided directly to the MCCAA on [email protected].
  • A signed statement from the applicant declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the product/formulation.
  • Letter of Access and Supply (if applicable) for technical equivalence sources.

Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.

SECTION 7: ARTICLE 43 (RENEWAL OF AUTHORISATION OF A PPP)

Compulsory documentation

In case of an application for an Article 43:

  • An application overview (cover letter), signed and addressed to the MCCAA.
  • Filled-in CoCh Article 43 report document.
  • Note: 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.
  • Documentation and statements listed in SANCO/2010/13170 (latest revision).
  • Draft Registration Report for Article 43 renewal and associated study reports (finalised, dated and signed).
  • Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
  • A Safety Data Sheet (SDS) for the product, each active substance and co-formulant in compliance with Commission Regulation (EU) 2020/878 amending Regulation (EC) No. 1907/2006 and classification in accordance with Regulation (EC) No 1272/2008. The SDSs shall not be older than 2 years from the submission of the application form.
  • Full (100%) chemical composition for each co-formulant, including a signed statement from the suppliers declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the co-formulants. If this is considered business confidential information for the suppliers, the required information shall be provided directly to the MCCAA on [email protected].
  • A signed statement from the applicant declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the product/formulation.
  • 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 document with the request for confidentiality of data in accordance with Appendix 10 of SANCO/13169/2010 Rev. 11.
  • Letter of Access (if applicable) for active substance and/or product data.
  • Letter of Access and Supply (if applicable) for technical equivalence sources.

Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.

Section 8: PAYMENT

Payments are to be affected via bank transfer in accordance with the quotations issued by the MCCAA for the administrative check submission and technical evaluation depending on the type of application. Proof of payment shall be submitted with the application form without delay. 

 

 

Bank Account Details

Bank name:

Bank of Valletta p.l.c.

IBAN number:

MT14VALL22013000000040019986609

Account number:

40019986609

Swift code:

VALLMTMT

Beneficiary name:

Malta Competition and Consumer Affairs Authority
(This question is mandatory)
Proof of Payment
 Upload files
DECLARATIONS
(This question is mandatory)
Content Declaration
(This question is mandatory)

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 Declaration
 

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