The Human Medicines Regulations 2012

Revocation, variation and suspension of traditional herbal registration U.K.

135.—(1) The licensing authority may revoke, vary or suspend a traditional herbal registration if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a) the product to which the registration relates is harmful;

(b) the pharmacological effects or efficacy of the product are no longer plausible; or

(c) the product's qualitative or quantitative composition is not as described in the application for the registration or the material accompanying it.

(3) Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a) a term of the registration; or

(b) a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that the holder of the registration has not complied with regulation 145(1) to (3) (requirement to provide information that may entail amendment of authorisation).

[F1 (6) Condition E is that the holder of the registration has ceased to be established in—

(a) the United Kingdom; or

(b) in relation to a THR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.]

(7) Condition F is that—

(a) the product to which the registration relates is manufactured in the United Kingdom; and

(b) the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with regulations 37 (manufacturing and assembly), 38 (imports from states other than EEA States [F2 / countries other than approved countries for import]), 39 (further requirements for manufacturer's licence), 40 (obligation to provide information relating to control methods) or 41 (requirements as to qualified persons).

(8) Condition G is that—

(a) the product to which the registration relates is manufactured in an EEA State F3 ...; and

(b) the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

(9) Condition H is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

(a) may suspend the registration; and

(b) [F4 in the case of a THR(NI) or THR(UK),] must notify the suspension to the EMA, the European Commission, and all other member States by the end of the next working day following the day on which the suspension comes into force.

(10) Condition I is that—

(a) the holder applies to vary the registration; and

(b) the licensing authority thinks that the application should be granted.

[F5 (10A) Condition J is that the manufacture of the product to which registration relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 12.]

[F6 (10B) Condition K is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.]

F7 (11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 135(6) substituted (31.12.2020) by S.I. 2019/775, reg. 119(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(a))

F2 Words in reg. 135(7)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 119(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 135(8)(a) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 119(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(c))

F4 Words in reg. 135(9)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 119(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(d)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Reg. 135(10A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 20

F6 Reg. 135(10B) inserted (31.12.2020) by S.I. 2019/775, reg. 119(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(e))

F7 Reg. 135(11) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 119(5); 2020 c. 1, Sch. 5 para. 1(1)