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Regulation 54 New paragraph 33A

Original text. Later amendments are not shown.

After paragraph 33 insert—

“Variation procedure

33A.
(1)

Subject to sub-paragraphs (2) and (6), an application for a variation must be submitted to the Secretary of State electronically.

(2)

Sub-paragraph (1) does not apply where the application is an emergency application.

(3)

The application must contain—

(a)

a description of the proposed variation;

(b)

information in relation to any of the matters referred to in paragraph 2 which are relevant to the proposed variation;

(c)

details of any marketing authorisation which may be affected by the proposed variation; and

(d)

where the proposed variation requires consequential variations to the terms of the marketing authorisation, a description of those variations.

(4)

The Secretary of State must produce an assessment of the application.

(5)

The Secretary of State may require the applicant to provide additional information during the assessment process.

(6)

Where the Secretary of State is satisfied that it is not necessary for the application to contain certain information for the purposes of conducting an assessment, having regard to the risks involved with the proposed variation, the Secretary of State may waive the requirement to provide that information under sub-paragraph (3) (and the requirement in sub-paragraph (4) does not apply in respect of that information).

(7)

The Secretary of State must send a copy of the assessment mentioned in sub-paragraph (4) to the applicant.

(8)

Having assessed the application, the Secretary of State must—

(a)

amend the authorisation to correspond with the proposed variation; or

(b)

reject the proposed variation.

(9)

Where the Secretary of State amends the authorisation in accordance with sub-paragraph (8)(a) the Secretary of State must notify the applicant in writing.

(10)

The Secretary of State must ensure that the determination of an application for a variation of a marketing authorisation is completed within a maximum of 180 days after the submission of the application.”.