Paragraph 2 Existing applications for marketing authorisationF1

(1)

An application for a UKMA(GB) made before 1st January 2025 which has not been determined immediately before that date is to be treated on and after that date as an application for a UKMA(UK).

(2)

Sub-paragraph (3) applies where—

(a)

an application for a UKMA(UK) was made before 1st January 2025,

(b)

the application has not been determined immediately before that date,

(c)

the application was made under regulation 51B as it had effect on the date of the application, and

(d)

the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(3)

Where this sub-paragraph applies, regulations 48 and 51B apply in respect of the application as they had effect immediately before 1st January 2025.

(4)

Sub-paragraph (5) applies where—

(a)

an application for a UKMA(UK) was made before 1st January 2025,

(b)

the application has not been determined immediately before that date,

(c)

the application was made under regulation 52B as it had effect on the date of the application, and

(d)

the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(5)

Where this sub-paragraph applies, regulations 48 and 52B apply in respect of the application as they had effect immediately before 1st January 2025.

(6)

Sub-paragraph (7) applies where—

(a)

an application for a UKMA(UK) was made before 1st January 2025,

(b)

the application has not been determined immediately before that date,

(c)

the application was made under regulation 53B as it had effect on the date of the application, and

(d)

the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(7)

Where this sub-paragraph applies, regulations 48 and 53B apply in respect of the application as they had effect immediately before 1st January 2025.

Annotations

Textual amendments

F1: Sch. 33B inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 146