CHAPTER III

PLANT PROTECTION PRODUCTS
SECTION 1

Authorisation
Subsection 4

Renewal, withdrawal and amendment

Renewal of authorisation
Article 43
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 in relation to a constituent territory of an active substance, safener or synergist contained in the plant protection product authorised in that constituent territory, the applicant shall submit the following information to 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 by 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
a
The 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 on renewal of the approval of the active substance, safener or synergist.
b
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.
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
The 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 competent authority examining the application shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.
Words in Art. 43(3)(a) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(b)(ii)(bb) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(3)(a) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(b)(ii)(aa) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(6) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(e) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Ch. 3 Section 1 Subsection 3 heading inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(16)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Ch. 3 Section 1 Subsection 3A inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(21) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(5)(f)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(2)(d) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(a)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(2) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(a)(i)(cc) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(2) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(a)(i)(bb) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Art. 43(4) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(c) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(5) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(d) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(2) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(a)(i)(aa) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Art. 43(3)(b) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(b)(iii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 43(3) renumbered as Art. 43(3)(a) (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(22)(b)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)