Application for Authorisation and Amendments to an Authorisation

A new EU application management system will be introduced in the coming months.  Applicants should familiarise themselves with this system. This system will initially be restricted to applications for authorisation of a new plant protection product (PPP) via the zonal evaluation system, mutual recognition and emergency use applications.

 

Application for authorisation of a new plant protection product (PPP) or amendment of an authorisation:

The Commission maintain guidelines on the zonal evaluation and authorisation procedure.  Where appropriate, applications should be submitted to the Pesticide Controls Division (pcs@agriculture.gov.ie).

 

Application for renewal of an authorisation:

The Commission maintain guidelines on the renewal of an authorisation procedure.  Where appropriate, applications should be submitted to the Pesticide Controls Division (pcs@agriculture.gov.ie).

 

Trivial (administrative) amendments to an existing authorisation:

For minor amendments (trivial amendments) to existing authorisations in Ireland, applications should be made to Pesticide Controls Division (pcs@agriculture.gov.ie).  The following should be included in all applications:

  1. A cover letter outlining the proposed amendment
  2. A draft amended label if appropriate

 

Mutual recognition:

Where a plant protection product (PPP) has been authorised in another Member State, the holder of that authorisation may apply for mutual recognition of that authorisation in Ireland.  Applications should be made to the Pesticide Controls Division (pcs@agriculture.gov.ie). The following should be included in all applications:

  1. Cover letter
  2. A copy of the dossier submitted to the reference MS
  3. A copy of the authorisation documents from the reference MS and where necessary translations of same into English
  4. A copy of the approved label from the reference MS
  5. A proposed Irish label

 

Specific data requirements for Ireland

There are specific requirements for Irish based trials on wet weather fungal diseases in relation to the authorisation of a plant protection product (PPP).

 

Comparative assessment

The Commission maintain guidelines on the comparative assessment procedure. 

Queries relating to comparative assessment in Ireland should be forwarded to:

E-mail:                  pcs@agriculture.gov.ie

Telephone:             00-353-1-6157552

Fax:                      00-353-1-6157575

Postal:                  Pesticide Registration & Control Division
                            Department of Agriculture, Food & the Marine,
                            Backweston Campus,
                            Young’s Cross,
                            Celbridge,
                            Co. Kildare,
                            IRELAND.

 

Fees