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Article 8 Application for a maximum residue limitF1

United Kingdom

Original text. Later amendments are not shown.

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 Secretary 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 Secretary 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 Secretary 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 Secretary 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 Secretary of State classifies a substance under Article 14(2)(b) or (d), the 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.

Annotations

Textual amendments

F1

Art. 8 substituted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), reg. 1(2), Sch. 9 Pt. 1 (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(5)(a)); 2020 c. 1, Sch. 5 para. 1(1)