340.—(1) Paragraph (2) applies for the purposes of proceedings under these Regulations for an offence consisting of offering a medicinal product for sale by retail in contravention of regulation 220 (sale or supply of products not subject to general sale) or 221 (sale or supply of products subject to general sale).
(2) If it is proved that the medicinal product in question was found on a vehicle from which medicinal products are sold, it is to be presumed, unless the contrary is proved, that the person in charge of the vehicle offered the medicinal product for sale.
(3) Paragraph (4) applies for the purposes of proceedings under these Regulations for an offence consisting of a contravention of a provision within paragraph (5), where it is proved that the medicinal product in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products.
(4) It is to be presumed, unless the contrary is proved, that the person charged possessed the medicinal product for the purpose of sale or supply.
(5) The provisions within this paragraph are regulations [F1268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 276 (offences: requirements relating to child safety) to the extent that they establish an offence based on possession of a medicinal product for the purpose of sale or supply.
Textual Amendments
F1Words in reg. 340(5) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZC (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)
341.—(1) Where the licensing authority notifies a person of a decision under these Regulations, it must—
(a)state its reasons for the decision; and
(b)inform the person of any action the person may take under these Regulations to challenge that decision and of the time for taking that action.
(2) Paragraph (1) is without prejudice to any other provision of these Regulations concerning notification by the licensing authority.
(3) The licensing authority must publicise any decision under these Regulations to which paragraph (4) applies in such manner as it thinks fit.
(4) Those decisions are—
(a)a decision to grant or revoke a [F2UK] marketing authorisation;
[F3(aa)a decision to grant or revoke an EU marketing authorisation;]
(b)a decision to grant or revoke a certificate of registration; and
(c)a decision to grant or revoke a traditional herbal registration.
Textual Amendments
F2Word in reg. 341(4)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 224(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 184)
F3Reg. 341(4)(aa) inserted (31.12.2020) by S.I. 2019/775, reg. 224(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 184)
342.—(1) This regulation applies if—
(a)by any provision of these Regulations a person is required to provide—
(i)any information or document to the licensing authority or to the Ministers, or
(ii)any assistance to the licensing authority or to the Ministers; and
(b)no time is specified in that provision within which the obligation must be performed.
(2) The obligation must be performed within such time as may be specified in a written notice given to the person by the licensing authority or the Ministers (as the case may be).
343.—(1) A notice or other document required or authorised by any provision of these Regulations to be served on a person, or to be given or sent to a person, may be served, given or sent—
(a)by delivering it to the person;
(b)by sending it by post to the person's usual or last known residence or place of business in the United Kingdom;
(c)in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or by sending it by post to the secretary or clerk of the body corporate at that office; or
(d)in the case of a Scottish partnership by delivering it to a partner or by sending it by post to the address of the principal office of the partnership; or
(e)if the person consents in writing to the use of electronic communication, by a means of electronic communication.
(2) Where a notice or other document is sent by means of electronic communication it is treated for the purposes of these Regulations as received on the day on which it is sent, unless the contrary is proved.
Modifications etc. (not altering text)
C1Reg. 343 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
344.—(1) If a person enforces a provision of these Regulations in accordance with functions conferred under Part 16 (enforcement), the relevant Minister must pay such amounts as the person may reasonably require in respect of expenses incurred in the course of enforcement.
(2) In paragraph (1) “the relevant Minister” means—
(a)in relation to enforcement in England, Wales, and Scotland, the Secretary of State; and
(b)in relation to enforcement in Northern Ireland, the Minister for Health, Social Services and Public Safety.
344A.—(1) The Ministers may by regulations modify the application of any of the specified provisions in circumstances where the United Kingdom, or any part of the United Kingdom, is experiencing or may experience a serious shortage of medicinal products, or of medicinal products of a specified description, arising from the withdrawal of the United Kingdom from the European Union.
(2) Regulations may only be made under paragraph (1) for the purposes of preventing, remedying or mitigating the serious shortage that is being or may be experienced.
(3) For the purposes of paragraph (1), the “specified provisions” are the provisions of Parts 1, 3 to 5, 10 to 13 and 16, and of the associated Schedules.
(4) The reference in paragraph (1) to a serious shortage arising from the withdrawal of the United Kingdom from the European Union includes reference to a serious shortage where the withdrawal of the United Kingdom from the European Union is one but not the only significant factor contributing to the shortage.
(5) No regulations under paragraph (1) may be made, or have effect, after the end of the period of two years beginning with IP completion day.
Textual Amendments
F4Regs. 344A, 344B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 225 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 185); 2020 c. 1, Sch. 5 para. 1(1)
344B.—(1) Regulations made under a power in the regulations listed in paragraph (2)—
(a)are to be made by statutory instrument;
(b)may make different provision for different purposes and different areas; and
(c)may include incidental, supplemental, consequential, transitional, transitory or saving provisions, including consequential amendments to these Regulations.
(2) The regulations referred to in paragraph (1) are—
(a)regulation B17(1) and (4) (good manufacturing practice);
(b)regulation 50(5A) (Annex I to the 2001 Directive);
(c)regulation 50G(5) (orphan criteria etc);
(d)regulations 59(3A) and 61(7A) (post-authorisation efficacy studies);
(e)regulation 65C(7) (variations of UK marketing authorisations);
(f)regulation 102(7) (homoeopathic medicinal products);
(g)regulation 205A(2) (further obligations in respect of pharmacovigilance activities);
(h)regulation 257E (certain forms of labelling); and
(i)regulation 344A (modifications to deal with serious shortages).
(3) A statutory instrument containing regulations made under the powers listed in paragraph (2) is subject to annulment in pursuance of a resolution of either House of Parliament.]
Textual Amendments
F4Regs. 344A, 344B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 225 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 185); 2020 c. 1, Sch. 5 para. 1(1)