Regulation 153 Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)I1

Regulation 193 is amended as follows.

In paragraph (1) substitute—

“(1)

Where products that are subject to different authorisations or registrations contain the same active substance or the same combination of active substances, the frequency and dates of submission may be amended and harmonised in accordance with—

(a)

Article 107c(4) of the 2001 Directive, where—

(i)

any of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation; and

(ii)

none of the authorisations or registrations is a UKMA(GB) or THR(GB); or

(b)

paragraphs (2A), (3) and (4A), where—

(i)

any of the authorisations or registrations is a UKMA(GB) or THR(GB); and

(ii)

none of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation.”;

In paragraph (2), after “holder” insert “of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”.

F3After paragraph (2) insert—

“F4(2A )

Where one or more of the grounds in paragraph (3) is met, the holder F5of a UKMA(GB) or THR(GB) may submit a request in writing to the licensing authority, or the licensing authority may in any event decide, to—

(a)

determine a UK reference date from which submission dates are calculated in respect of products that fall under paragraph (1); or

(b)

change the frequency and date of submission of the PSUR.”.

F6After paragraph (4) insert—

“F7(4A)

Where the licensing authority makes a decision under paragraph (2) following a written request from a holder F8of a UKMA(GB) or THR(GB), it must notify that holder in writing of its decision to approve or refuse the request.”.

In paragraph (5)—

F11After paragraph (6) insert—

“F12(6A)

Subject to paragraph F13(6B), in this regulation, “UK reference date” means a date determined by the licensing authority under paragraph (2)(a) in respect of medicinal products containing the same active substance or the same combination of active substances.

(6B)

Until the licensing authority makes a decision under paragraph (2), any—

(a)

Union reference date in respect of medicinal products containing the same active substance or the same combination of active substances; or

(b)

date of submission and frequency of periodic safety reports in respect of such products,

published by the EMA under Article 107c(7) of the 2001 Directive, is deemed to be the UK reference date or, as the case may be, the required date or frequency of PSUR submission, in respect of those medicinal products.”.

After paragraph F14(6B) insert—

“(7)

The licensing authority must publish a list of—

(a)

UK reference dates it determines under paragraph (2); and

(b)

the required date of submission and frequency for PSURs in respect of medicinal products containing the same active substance or the same combination of active substances.

(8)

Any change to the date of submission and frequency of PSURs as a result of the application of this regulation is to take effect after a 6 month period, such period beginning with the day after the licensing authority publishes that change under paragraph (7).”.