PART 11Pharmacovigilance
Periodic Safety Update Reports
Obligation on holder to submit periodic safety update reports: derogation from general requirements192
1
This regulation applies in relation to medicinal products granted—
a
b
a traditional herbal registration.
2
In the following paragraphs of this regulation—
“authorisation or registration” means a marketing authorisation to which paragraph (1)(a) applies or a traditional herbal registration;
“the holder” means the holder of a marketing authorisation to which paragraph (1)(a) applies or of a traditional herbal registration; and
“product” means a product to which a marketing authorisation referred to in paragraph (1)(a) or a traditional herbal registration relates.
3
The holder must submit PSURs in relation to the product to the EMA in accordance with paragraph (5)—
a
where requested to do so by the licensing authority in accordance with paragraph (4); or
b
in the case of a product to which paragraph (1)(a) applies, where it is a condition to which the marketing authorisation for the product is subject by virtue of regulations 59 (conditions of UK marketing authorisation: general) or 60 (conditions of UK marketing authorisation: exceptional circumstances) to do so.
4
The licensing authority may request the holder to submit PSURs where—
a
it has concerns relating to the product’s pharmacovigilance data; or
b
it considers there is a lack of PSUR data relating to an active substance of the product after the authorisation or registration is granted.
5
The submission of PSURs under paragraph (3) must be in accordance with—
a
where the PSUR is submitted pursuant to a request under paragraph (3)(a), the terms of the request; and
b
where the PSUR is submitted pursuant to a condition under paragraph (3)(b), the terms of the condition.
6
Each PSUR must contain—
a
summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation or registration for the product;
b
a scientific evaluation of the risk-benefit balance of the product; and
c
all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.
7
For the purposes of paragraph (6)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation or registration for the product.
8
Each PSUR must be submitted electronically.
9
Where the licensing authority requests submission of PSURs under paragraph (3)(a), it must communicate a PSUR assessment report to the EMA as soon as is reasonably practicable after each report is received.
10
In this regulation “PSUR assessment report” means a report which evaluates the information provided in a PSUR.
11
This regulation is subject to regulation 212 (transitional arrangements).