
Article 1 

(1.) This Regulation lays down the procedure for the determination of the existing renewal application by the relevant competent authority as assessing competent authority.
(2.) The  “existing renewal application” is the application for the renewal of the approval of the active substance famoxadone which—
(a) was made to the United Kingdom as rapporteur Member State in accordance with Article 4 as it had effect immediately before  IP completion day, and
(b) is taken as being made under this Regulation and Article 15(1) of Regulation (EC) No 1107/2009 on the date on which it was made.
(3.) Anything done under this Regulation as it had effect immediately before  IP completion day  in relation to the existing renewal application—
(a) by the United Kingdom as rapporteur Member State;
(b) by the European Food Safety Authority;
is taken to have been done by the relevant competent authority as the assessing competent authority.
(4.) In this Article—
(a) “rapporteur Member State” has the meaning given in Article 2(c) as it had effect immediately before  IP completion day;
(b) the  “relevant competent authority” is the Secretary of State.
Article 2 
For the purposes of this Regulation the following definitions shall apply:

((a)) ‘producer’ means the person who manufactures the active substance on his own or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;
((b)) ‘applicant’ means the producer who made the existing renewal application;
((c)) ...
((d)) ...
((e)) ...
((f)) ...
((g)) ‘Regulation (EC) No 1107/2009’ means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;
((h)) ‘assessing competent authority’ has the meaning given by  Article 15(1A)  of Regulation (EC) No 1107/2009;
((i)) ‘existing renewal application’ has the meaning given by Article 1(2).
Article 2a 

(1.) Where the assessing competent authority considers that additional data from the applicant is necessary to finalise the relevant conclusion, the assessing competent authority may set a period of up to one month for the applicant to supply that data.
(2.) The assessing competent authority must notify the other competent authorities—
(a) as to the data received in accordance with paragraph 1, or
(b) where no data is received during the period described in paragraph 1.
(3.) On request from a competent authority, the assessing competent authority must provide a copy of data received in accordance with paragraph 1.
(4.) The assessing competent authority must send the other competent authorities a finalised conclusion as soon as reasonably practicable after the conclusion is finalised.
(5.) Article 20 of Regulation (EC) No 1107/2009 applies to the determination of an existing renewal application, and for the purpose of that Article an existing renewal application is taken to relate to each constituent territory.
(6.) In paragraph 1,  “relevant conclusion” means the conclusion of the European Food Safety Authority in respect of the existing renewal application, delivered in accordance with the second subparagraph of Article 16(2) as it had effect immediately before  IP completion day.
(7.) In this Article,  “competent authority” and  “constituent territory” have the meanings given in Article 3A of Regulation (EC) No 1107/2009.
Article 3 
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Article 4 
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Article 5 
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Article 6 
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Article 7 
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Article 8 
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Article 9 
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Article 10 
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Article 11 
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Article 12 
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Article 13 
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Article 14 
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Article 15 
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Article 16 
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Article 17 
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Article 18 
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Article 19 
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Article 20 
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Article 21 
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ANNEX I

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ANNEX II
The application shall be in writing, signed by the applicant, and sent by registered mail to the rapporteur Member State listed in column B of Annex I and to the co-rapporteur Member State listed in column C of Annex I.
A copy of the application without the updating statement shall be sent to the European Commission, DG Health and Consumers, unit E3, 1049 Brussels, Belgium and to the Authority, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma, Italy.
The application shall be submitted in accordance with the following model.
 1.  1.1. 
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 2.  2.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
An updating statement, as provided for in Article 5(2), shall be attached as an Annex to the application.
The applicant confirms that the above information submitted on … (date) is correct.
Signature (of the person competent to act for the applicant referred to under 1.1)
