Regulation 167G EAMS medicinal products: pharmacovigilanceF1

(1)

F2Subject to paragraphs (1A) and (1B), the EAMS scientific opinion holder must comply with the following pharmacovigilance requirements in respect of an EAMS medicinal product—

(a)

a risk management system must be agreed with the licensing authority and operated by the EAMS scientific opinion holder in accordance with the risk management plan;

(b)

the EAMS scientific opinion holder must record and maintain adverse reaction reports in respect of the EAMS medicinal product and must ensure that these reports are accessible (electronically or physically) at a single point within the United Kingdom;

(c)

the EAMS scientific opinion holder must submit electronically to the licensing authority—

(i)

a report on all serious suspected adverse reactions that occur within 15 days of receipt, and

(ii)

a report on all non-serious suspected adverse reactions that occur in the United Kingdom within 90 days of receipt,

and must ensure that the reports referred to in sub-paragraphs (i) and (ii) are in the format and content specified by Part 6 of Schedule 12A F3and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available;

(d)

the EAMS scientific opinion holder must—

(i)

establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports, and

(ii)

collect follow-up information on reports submitted under sub-paragraphs (c)(i) and (c)(ii) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period;

(e)

the EAMS scientific opinion holder must submit periodic reports, in the manner specified in conditions attached under regulation 167C(2)(c), on the use of the EAMS medicinal product to the licensing authority, and where reasonably practicable, these reports must contain—

(i)

details of any suspected adverse drug reaction to the medicinal product,

(ii)

a summary of any significant new data on the quality, safety or efficacy of the medicinal product concerned,

(iii)

any proposed updates to the medicinal product information,

(iv)

all data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product in the United Kingdom, and

(v)

a scientific evaluation of the risk-benefit balance of the medicinal product;

(f)

the EAMS scientific opinion holder must notify the licensing authority without delay if it detects any relevant changes in relation to the EAMS medicinal product, and for these purposes, “relevant changes” means—

(i)

new risks,

(ii)

risks that have changed, and

(iii)

changes to the risk-benefit balance; and

(g)

the EAMS scientific opinion holder must—

(i)

record all pharmacovigilance information required under this regulation,

(ii)

maintain those records for at least five years beginning on the date on which the EAMS scientific opinion ceases to have effect in accordance with regulation 167D(1) (subject to any winding down period provided for in accordance with regulation 167D(2)), and

(iii)

make those records available to the licensing authority or to the enforcement authority on request.

(F41A)

In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

(1B)

In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

(2)

Nothing in paragraph (1) precludes the meeting of the requirements of that paragraph within systems or other arrangements established for other medicinal products (including for an authorised product the marketing authorisation of which may, in due course, be varied to take account of the advantage identified in the EAMS scientific opinion in respect of the EAMS medicinal product).

Annotations

Textual amendments

F1: Regs. 167C-167H inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 8 (with reg. 19)
F2: Words in reg. 167G(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(a)
F3: Words in reg. 167G(1)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(b)
F4: Reg. 167G(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(3)