The Human Medicines Regulations 2012

Revocation, variation and suspension of traditional herbal registrationU.K.

Revocation, variation and suspension of traditional herbal registrationU.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)[F4in 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

Revocation by licensing authority: further provisionsU.K.

136.—(1) The licensing authority must revoke a traditional herbal registration if—

(a)the application for the registration was submitted in accordance with regulation 128(3) on the basis that the herbal medicinal product to which it relates was contained in

[F8(i)the list referred to in Article 16f(1) of the 2001 Directive, in the case of a THR(NI) or THR(UK);

(ii)the list established under regulation 126A where the application is for a THR(GB); and]

(b)the product ceases to be contained in that list.

(2) Paragraph (1) does not apply if within the period of three months beginning immediately after the day on which product ceases to be contained on the list the holder—

(a)submits to the licensing authority the material specified in Schedule 12 (including that referred to in paragraphs 16 to 20 of Part 1 of that Schedule) in relation to the product; and

(b)provides the licensing authority with any material or information that the licensing authority reasonably considers necessary for considering the application and requests the holder to provide.

F9(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F8Reg. 136(1)(a)(i)(ii) substituted for words in reg. 136(1)(a) (31.12.2020) by S.I. 2019/775, reg. 120(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 92); 2020 c. 1, Sch. 5 para. 1(1)

Procedures for revocation, variation or suspensionU.K.

137.  Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a traditional herbal registration, other than a proposal to vary a registration on the application of its holder.

Suspension of use etc of traditional herbal medicinal productU.K.

138.—(1) The licensing authority may suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates if any of the following conditions are met.

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

(a)the product 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 holder has not complied with regulation 145(7) (requirements to provide proof of controls on manufacturing process).

(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 paragraph (4) or (5) of regulation 23 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product.

(6) A suspension under this regulation may relate to batches of the product.

(7) The licensing authority must give notice in writing of a suspension under this regulation to the holder of the registration.

(8) The licensing authority must provide in the notice that the suspension—

(a)is to take effect immediately or from a date specified in the notice; and

(b)is to apply for the period specified in the notice.

(9) Where a medicinal product is the subject of a suspension under this regulation, the licensing authority may—

(a)in exceptional circumstances; and

(b)for such a transitional period as the licensing authority may determine,

allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

F10(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Registrations granted under Chapter 4 of Title III of the 2001 DirectiveU.K.

F11139.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Withdrawal of traditional herbal medicinal product from the marketU.K.

140.—(1) This regulation applies if—

[F12(a)under—

(i)regulation 135 or 136, in the case of a THR(GB);

(ii)regulation 135 or 136 or Article 34(3) of the 2001 Directive, in the case of a THR(NI) or THR(UK),

the licensing authority revokes or suspends the registration; or]

(b)under regulation 138 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the registration requiring the holder to comply with both of the following requirements.

(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the registration relates of—

(a)the revocation or suspension;

(b)the reasons for the revocation or suspension; and

(c)any action to be taken to restrict or prevent further use, sale, supply or offer for sale or supply of the product.

(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a)the product; or

(b)the batches of the product specified in the notice,

within the time and for the period specified in the notice.

Textual Amendments

Sale etc of suspended traditional herbal medicinal productU.K.

141.—(1) This regulation applies if the use, sale, supply or offer for sale or supply of a traditional herbal medicinal product is suspended in accordance with regulation 138 F13....

(2) A person must not—

(a)sell, supply or offer to sell or supply the product; or

(b)procure the sale, supply or offer for sale or supply of the product,

knowing, or having reasonable cause to believe, that such use, sale, supply or offer for sale or supply is suspended.

Textual Amendments