OpenLegislation

Regulation 33 Duty to notify Secretary of State ...F11E1

England, Wales and Scotland

F1(A1)

The Secretary of State must establish and operate a database containing information relating to market surveillance and product safety.

F2(B1)

The database referred to in paragraph (A1) must be designed so as to enable notifications required under paragraph (1), (2) or (4), or under Article 22 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, to be made to the Secretary of State through the database.

F3(1)

An enforcement authority which has received a notification of a risk under regulation 9(1) shall immediately notify the Secretary of State of the risk through the database referred to in paragraph (A1).

(2)

Where an enforcement authority takes a measure which restricts the placing on the market of a product, or requires its withdrawal or recall, it shall immediately notify the Secretary of State F4of the action taken through the database referred to in paragraph (A1), specifying its reasons for taking the action. It shall also immediately notify the Secretary of State of any modification or lifting of such a measure.

F5(3)

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(4)

Where an enforcement authority adopts or decides to adopt, recommend or agree with producers and distributors, whether on a compulsory or voluntary basis, a measure or action to prevent, restrict or impose specific conditions on the possible marketing or use of a product (other than a F6medicinal product) by reason of a serious risk, it shall immediately notify the Secretary of State F7of the measure or action taken through the database referred to in paragraph (A1). It shall also immediately notify the Secretary of State of any modification or withdrawal of any such measure or action F8through the database referred to in paragraph (A1).

F9(5)

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(6)

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(7)

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(8)

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(9)

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(10)

In this regulation—

(a)

references to a product excludes a second hand product supplied as an antique or as a product to be repaired or reconditioned prior to being used, provided the supplier clearly informs the person to whom he supplies the product to that effect;

F10(b)

“medicinal product” has the meaning given to it in regulation 2 of the Human Medicines Regulations 2012.

Annotations

Textual amendments

F1

Reg. 33(A1) inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(3) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F2

Reg. 33(B1) inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(4) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F3

Reg. 33(1) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(5) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4

Words in reg. 33(2) inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(6) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F5

Reg. 33(3) omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(7) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6

Word in reg. 33(4) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(8)(a) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F7

Words in reg. 33(4) inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(8)(b) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8

Words in reg. 33(4) inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(8)(c) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F9

Reg. 33(5)-(9) omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(9) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F10

Reg. 33(10)(b) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(10) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F11

Words in reg. 33 heading omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 9 para. 6(2) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1

This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only