The Human Medicines Regulations 2012

PART 9 U.K. Borderline products

Provisional determination U.K.

159.—(1) This regulation applies if the licensing authority thinks that a product without a [F1 UK] marketing authorisation, traditional herbal registration, certificate of registration or [F2 , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,] is a medicinal product.

(2) The licensing authority may give a notice in writing (a “provisional determination notice”) to any person (the “recipient”)—

(a) who has sold or supplied the product, or has offered to sell or supply it; or

(b) whom the licensing authority thinks may sell or supply the product.

(3) The provisional determination notice must—

(a) advise the recipient that the licensing authority has made a provisional determination that the product is a medicinal product;

(b) give reasons for the provisional determination;

(c) advise the recipient of the recipient's rights to challenge the provisional determination in accordance with regulation 160 and

(d) specify a period of at least six weeks beginning immediately after the date on which the provisional determination notice is given to the recipient (in this Part “the determination date”) within which any written representations in accordance with regulation 160(2)(a) must be made to the licensing authority.

Textual Amendments

F1 Word in reg. 159(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 133(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 159(1) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 133(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 100)

Challenge to provisional determination U.K.

160.—(1) A recipient of a provisional determination notice may, within the period of four weeks beginning immediately after the determination date, give notice in writing to the licensing authority requesting the authority to submit the provisional determination to review.

(2) If the recipient gives such notice the recipient must—

(a) within the period specified in the provisional determination notice, make written representations to the licensing authority explaining why the recipient thinks the product is not a medicinal product; or

(b) within the period of four weeks beginning immediately after the determination date, inform the licensing authority in writing that the recipient wants to make oral representations explaining why the recipient thinks the product is not a medicinal product.

(3) If—

(a) the recipient has informed the licensing authority that the recipient wants to make written representations in accordance with paragraph (2)(a); and

(b) the licensing authority thinks that, because of exceptional circumstances or the nature or complexity of the issues involved, additional time is needed for the preparation of written representations,

the licensing authority may alter the period for making written representations.

(4) The licensing authority must inform the recipient in writing of an alteration under paragraph (3) and of the reasons for it.

Written representations procedure U.K.

161.—(1) If a recipient makes written representations in accordance with regulation 160(2)(a) the licensing authority must appoint a panel of at least two persons (“the reviewers”) to advise on the provisional determination.

(2) The licensing authority must provide the reviewers with—

(a) the recipient's written representations; and

(b) any written representations of the licensing authority.

(3) The reviewers must advise the licensing authority on the authority's provisional determination taking account of—

(a) the written representations; and

(b) any other evidence submitted to them.

(4) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(5) The licensing authority must—

(a) inform the recipient in writing of its final determination and of the reasons for it; and

(b) if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Oral representations procedure U.K.

162.—(1) If a recipient informs the licensing authority in accordance with regulation 160(2)(b) that the recipient wants to make oral representations, the licensing authority must—

(a) appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b) after consultation with the recipient set a date for the hearing.

(2) The licensing authority may alter the date of the hearing at the request of the recipient or of its own motion if it thinks that because of exceptional circumstances or the nature or complexity of the issues involved additional time is needed for preparation for the hearing.

(3) The licensing authority must inform the recipient in writing of any alteration under paragraph (2) and of the reasons for it.

(4) The recipient and the licensing authority may make oral representations at the hearing.

(5) The reviewers must advise the licensing authority on the authority's provisional determination, taking account of—

(a) the oral representations made and any other evidence submitted by the recipient at the hearing;

(b) any oral representations made or other evidence submitted by the licensing authority at the hearing; and

(c) any other evidence heard by the review panel.

(6) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(7) The licensing authority must—

(a) inform the recipient in writing of its final determination and of the reasons for it; and

(b) if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Final determination without representations U.K.

163.—(1) This regulation applies if the recipient—

(a) does not give notification to the licensing authority that the recipient wishes to challenge its provisional determination within the period of four weeks beginning immediately after the determination date;

(b) gives such notification, but fails to make written representations to the licensing authority within the period for making those representations; or

(c) gives such notification, but fails to make oral representations at a hearing before the reviewers appointed for the purposes of advising on the provisional determination.

(2) The licensing authority must—

(a) make a final determination as to whether the product is a medicinal product; and

(b) inform the recipient in writing of its final determination and of the reasons for it.

Effect of final determination U.K.

164.—(1) If the licensing authority makes a final determination that a product is a medicinal product, it may give a notice to any person—

(a) who has sold or supplied the product, or has offered to sell or supply it; or

(b) whom the licensing authority thinks may sell or supply the product.

(2) The notice must require the person—

(a) to cease to sell, supply or offer to sell or supply the product from the date specified in the notice until a [F3 UK] marketing authorisation, traditional herbal registration, certificate of registration or [F4 , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,] is granted in respect of the product; or

(b) not to sell, supply or offer to sell or supply the product unless a [F5 UK] marketing authorisation, traditional herbal registration, certificate of registration or [F6 , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,] is granted in respect of the product.

Textual Amendments

F3 Word in reg. 164(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 164(2)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)

F5 Word in reg. 164(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 164(2)(b) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)

Determination in other cases U.K.

165.  Nothing in this Part prevents the licensing authority from determining that a product is a medicinal product [F7 in relation to these Regulations] without following the procedures in this Part when it thinks it appropriate.

Textual Amendments

F7 Words in reg. 165 inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 3 and words in reg. 165 inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 3

Offences relating to borderline products U.K.

166.—(1) A person is guilty of an offence if that person sells or supplies, or offers to sell or supply a product in breach of a notice under regulation 164(1) imposing a requirement under—

(a) regulation 164(2)(a); or

(b) regulation 164(2)(b).

(2) A person guilty of an offence under this regulation is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.