CHAPTER IIIPLANT PROTECTION PRODUCTS

F4F5SECTION 1Authorisation

Subsection 4Renewal, withdrawal and amendment

Article 43Renewal of authorisation

1

An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.

2

Within 3 months from the renewal of the approval F11in relation to a constituent territory of an active substance, safener or synergist contained in the plant protection product F8authorised in that constituent territory, the applicant shall submit the following information F7to the competent authority for that constituent territory:

a

a copy of the authorisation of the plant protection product;

b

any new information required as a result of amendments in data requirements or criteria;

c

evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;

d

any information required to demonstrate that the plant protection product meets the requirements set F6by the competent authority on the renewal of the approval of the active substance, safener or synergist contained therein;

e

a report on the monitoring information, where the authorisation was subject to monitoring.

3

F13a

F2The competent authority examining the application shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for F1on renewal of the approval of the active substance, safener or synergist.

F12b

The competent authority which examined the plant protection product application in accordance with Article 35(2) may coordinate the compliance check and assessment of the information submitted for all competent authorities which receive an application for renewal of authorisation for the same product, provided that the conditions in Article 35(2) apply in relation to the renewal application.

F94

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5

F10The competent authority examining the application shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.

6

Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the F3competent authority examining the application shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.