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The Human Medicines Regulations 2012

Changes over time for: Cross Heading: Offences relating to advanced therapy medicinal products

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The Human Medicines Regulations 2012, Cross Heading: Offences relating to advanced therapy medicinal products is up to date with all changes known to be in force on or before 29 March 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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  • Sch. 11 para. 1(1)(d)-(f) inserted by S.I. 2019/775 reg. 63(2)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(a)(ii) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(2))
  • Sch. 33A para. 57A inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(4) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • Sch. 33A para. 57(3) substituted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • Sch. 33A para. 57(2) words inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by S.I. 2019/1385 Sch. 1 para. 5 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
  • reg. 52(1)(a)(i)(ii) and words substituted by S.I. 2019/775 reg. 57(2) (This amendment not applied to legislation.gov.uk. Reg. 57 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 42)
  • reg. 53(2)-(2C) substituted for reg. 53(2) by S.I. 2019/775 reg. 58(3) (This amendment not applied to legislation.gov.uk. Reg. 58 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 43)
  • reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by S.I. 2019/1385 Sch. 1 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
  • reg. 173(e) inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
  • reg. 240(2A) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(c) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
  • reg. 240(6A) inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(g) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
  • reg. 247A(7) inserted by S.R. 2024/68 reg. 5(4)
  • reg. 247A(7) inserted by S.I. 2024/344 reg. 5(4)

Offences relating to advanced therapy medicinal productsU.K.

Offences in connection with risk management systems and traceability systemsU.K.

87.—(1) The holder of an EU marketing authorisation for an advanced therapy medicinal product is guilty of an offence if the holder fails to—

(a)submit an additional report evaluating the effectiveness of a risk management system and the results of studies within the period of 21 days beginning on the day following receipt of a request made under the second sub-paragraph of Article 14(2) of Regulation (EC) No 1394/2007, or such longer period as the EMA may specify; or

(b)include in any periodic safety update report referred to in Article 28(2) of Regulation (EC) No 726/2004 an evaluation of the effectiveness of a risk management system or of the results of any study performed pursuant to the first sub-paragraph of Article 14(2) of Regulation (EC) No 1394/2007, as required by the third sub-paragraph of Article 14(2).

(2) A person who is, or who immediately before its revocation or withdrawal was, the holder of an EU marketing authorisation for an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a)establish and maintain a traceability system in accordance with the requirements set out in Article 15(1) of Regulation (EC) No 1394/2007;

(b)where the product contains human cells or tissues, to ensure that the traceability system is complementary to and compatible with the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC, as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC, as regards blood cells; or

(c)to keep the data to which the traceability system relates in accordance with the requirements of Article 15(4) of Regulation (EC) No 1394/2007.

Offence concerning data for advanced therapy medicinal productsU.K.

88.—(1) A person who is, or immediately before its revocation or suspension was, the holder of an EU marketing authorisation relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a)keep the data referred to in Article 15(1) of Regulation (EC) No 1394/2007 in accordance with the requirements of Article 15(4) of that Regulation; or

(b)transfer the data referred to in Article 15(1) to the EMA in the event of that person's bankruptcy or liquidation in accordance with Article 15(5),

but this is subject to paragraph (2).

(2) Paragraph (1)(b) does not apply if—

(a)the person is bankrupt or in liquidation and has transferred the data to another person; or

(b)the period for which the person was required to keep the data in accordance with the requirements of Article 15(4) mentioned in paragraph (1)(a) has expired.

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