The Human Medicines Regulations 2012

Harmonisation of PSUR frequency or date of submission

193.—(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; or

(b) paragraphs (2) to (4).

(2) The holder may, where one or more of the grounds in paragraph (3) is met, submit a request in relation to the product to the EMA—

(a) to determine an EU reference date; or

(b) to change the frequency of submission of the PSUR.

(3) The grounds in this paragraph are—

(a) reasons relating to public health;

(b) in order to avoid duplication of the assessment; or

(c) in order to achieve international harmonisation.

(4) The second paragraph of Article 107c(6) of the 2001 Directive has effect in relation to the submission and determination of a request under paragraph (2).

(5) Where the frequency or dates of submission of a PSUR are changed in accordance with Article 107c(4) or Article 107c(6) of the 2001 Directive, the holder must apply to vary the product’s authorisation or registration to reflect the new frequency or date of submission before the end of the period of six months beginning on the day after the change is made public by the EMA.

(6) In this regulation, “EU reference date” in relation to a product means—

(a) the date of the first marketing authorisation in the EEA of a medicinal product containing the same active substance or the same combination of active substances as that product; or

(b) if the date referred to in point (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations in the EEA for a medicinal product containing the same active substance or the same combination of active substances as that product.