The Human Medicines Regulations 2012

[F1 PART 7 U.K. Risk management plans

Textual Amendments

F1 Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)

Content of the risk management plan U.K.

22.— (1) The risk management plan established by the holder must contain the following elements—

(a) an identification or characterisation of the safety profile of the medicinal product concerned;

(b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned;

(c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those measures; and

(d) a documentation of post-authorisation obligations that have been imposed as a condition of the UKMA(GB).

(2) Medicinal products may, where appropriate be subject to the same risk management plan if they—

(a) contain the same active substance; and

(b) belong to the same holder.

(3) Where a risk management plan refers to post-authorisation studies—

(a) it must indicate whether those studies are initiated, managed or financed by the holder voluntarily, or pursuant to obligations imposed by the licensing authority or an equivalent authority to the licensing authority in another country; and

(b) all post-authorisation obligations must be listed in the summary of the risk management plan referred to in paragraph 23, together with a timeframe for meeting those obligations.

Summary of the risk management plan U.K.

23.— (1) The summary of the risk management plan to be made publicly available in accordance with regulation 203(2)(d) (obligations on licensing authority in relation to national medicines web-portal) must include key elements of the risk management plan with a specific focus on risk minimisation activities and, with regard to the safety specification of the medicinal product concerned, important information on potential and identified risks as well as missing information.

(2) Where a risk management plan concerns more than one medicinal product, a separate summary of the risk management plan must be provided by holders for each medicinal product.

Updates of the risk management plan U.K.

24.— (1) Subject to sub-paragraph (2), where the holder updates a risk management plan, it must submit the updated risk management plan to the licensing authority.

(2) If the licensing authority agrees, the holder may submit only the modules concerned by the update.

(3) If necessary, the holder must provide the licensing authority with an updated summary of the risk management plan.

(4) Each submission of the risk management plan must—

(a) have a distinct version number; and

(b) be dated.

Format of the risk management plan U.K.

25.   The risk management plan must be in the following format—

(a) Part I: product overview;

(b) Part II: safety specification consisting of—

(i) Module SI: epidemiology of each indication and each target population,

(ii) Module SII: non-clinical part of the safety specification,

(iii) Module SIII: clinical trial exposure,

(iv) Module SIV: populations not studied in clinical trials,

(v) Module SV: post-authorisation experience,

(vi) Module SVI: additional EU requirements for the safety specification,

(vii) Module SVII: identified and potential risks, and

(viii) Module SVIII: summary of the safety concerns;

(c) Part III: pharmacovigilance plan, including post-authorisation safety studies;

(d) Part IV: plans for post-authorisation efficacy studies;

(e) Part V: risk minimisation measures, including evaluation of the effectiveness of risk minimisation activities;

(f) Part VI: summary of the risk management plan; and

(g) Part VII: annexes.]