Part 1 New Article 8I1

“Article 8

Application for a maximum residue limit

1

An application under these Regulations for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product must be made to the F1Secretary of State.

2

An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety of the substance.

3

The applicant must pay to the F2Secretary of State the application fee, which is—

(a)

for a new maximum residue limit in respect of a substance, £62,300;

(b)

for an amended maximum residue limit in respect of a substance, £18,850.

4

The F3Secretary of State must ensure that where a valid application is received, the substance is classified under Article 14 within 210 days.

5

For the purposes of paragraph 4 an application is valid when both the requirements in paragraphs 2 and 3 have been complied with.

6

As soon as practicable after the substance is classified under Article 14, the F4Secretary of State must publish—

(a)

a notice setting out the classification;

(b)

the assessment report that has been prepared, with any commercially confidential or personal information deleted.

7

If the F5Secretary of State classifies a substance under Article 14(2)(b) or (d), F6the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee under regulation 29 of the Veterinary Medicines Regulations 2013.

F78

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