The Human Medicines Regulations 2012 No. 1916

SCHEDULES

Regulations 294, 295 and 297

SCHEDULE 30 U.K. Particulars for advertisements to persons qualified to prescribe or supply

1.  The number of the [F1 UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product. U.K.

Textual Amendments

F1 Words in Sch. 30 para. 1 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)

2.  The name and address of the holder of [F2 the temporary authorisation or] the [F3 UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product or the business name and address of the part of the holder's business that is responsible for its sale or supply. U.K.

Textual Amendments

F2 Words in Sch. 30 para. 2 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(2) and words in Sch. 30 para. 2 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(2)

F3 Words in Sch. 30 para. 2 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)

[F4 2A.   In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).] U.K.

Textual Amendments

F4 Sch. 30 para. 2A inserted by S.I. 2019/775, regs. 1, 216(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)

3.  The classification of the medicinal product as— U.K.

(a) a product that is subject to general sale;

(b) a prescription only medicine; or

(c) a pharmacy medicine.

4.  The name of the medicinal product. U.K.

5.  A list of the active ingredients of the medicinal product that uses their common names and is placed immediately adjacent to the most prominent display of the name of the product. U.K.

6.  One or more of the indications for the medicinal product consistent with the terms of the [F5 UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the product [F6 or, in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174, the indications for the medicinal product consistent with the recommendation or requirement of the licensing authority as to the use of that product]. U.K.

Textual Amendments

F5 Words in Sch. 30 para. 6 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)

F6 Words in Sch. 30 para. 6 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(3) and words in Sch. 30 para. 6 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(3)

7.   [F7 The entries or a] succinct statement of the entries (if any) in the summary of the product characteristics[F8 , or in any equivalent summary published by the holder of a temporary authorisation,] relating to—

(a) adverse reactions, precautions and relevant contra-indications;

(b) dosage and method of use so far as relevant to the indications shown in the advertisement, and

(c) where this is not obvious, method of administration so far as relevant to those indications.

Textual Amendments

F7 Words in Sch. 30 para. 7 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 29 and words in Sch. 30 para. 7 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 29

F8 Words in Sch. 30 para. 7 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(4) and words in Sch. 30 para. 7 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(4)

8.  The cost excluding value added tax of— U.K.

(a) a specified package of the medicinal product; or

(b) a specified quantity or recommended daily dose of the medicinal product calculated by reference to a specified package of the medicinal product.

This paragraph does not apply to an advertisement inserted in a publication that is printed in the United Kingdom but that has a circulation outside the United Kingdom of more than 15 per cent of its total circulation.

9.—(1) The particulars specified in paragraph 7 must be printed in a clear and legible manner. U.K.

(2) Those particulars must be placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.