- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (31/03/2014)
- Gwreiddiol (a wnaed Fel)
Point in time view as at 31/03/2014.
The Human Medicines Regulations 2012, Section 210 is up to date with all changes known to be in force on or before 18 August 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.
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
210.—(1) A person is guilty of an offence if the person—
(a)commits a breach of a provision of Regulation (EC) No 726/2004 listed in paragraph (3); or
(b)provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in Chapter 3 of Title II of Regulation (EC) No 726/2004.
(2) A breach of a provision listed in paragraph (3) includes any—
(a)failure to comply with any requirement or obligation contained in any of those provisions;
(b)contravention of any prohibition contained in any of those provisions; or
(c)failure to comply with any requirement imposed by the licensing authority or the EMA pursuant to any of those provisions.
(3) Those provisions are—
(a)Article [F116(3a)], second paragraphM1;
(b)Article 20(8)M2;
(c)Article 21(1) and (2)M3;
(d)Article 22M4;
(e)Article 28(1), (2) and (5)M5;
(f)Article 28a(3)M6; and
(g)Article 28b(1)M7, except insofar as it imposes an obligation under Article 107n(1), or the first paragraph of Article 107n(3), of the 2001 Directive.
(4) Subject to paragraph (5), 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.
(5) A person guilty of an offence under this regulation in relation to a provision of Regulation (EC) No 726/2004 listed in paragraph (6) is liable—
(a)on summary conviction to a fine not exceeding the statutory maximum; or
(b)on conviction on indictment to a fine.
(6) Those provisions are—
(a)Article [F216(3a)], second paragraph;
(b)Article 21(1) insofar as it relates to obligations set out in—
(i)the second paragraph of Article 104(2) of the 2001 Directive save the obligation regarding preparing and implementing a corrective action plan,
(ii)Article 104(3)(a) of the 2001 Directive,
(iii)Article 104(3)(b) of the 2001 Directive, or
(iv)the second paragraph of Article 104(3) of the 2001 Directive;
(c)Article 21(2) insofar as it relates to the obligation to submit a detailed description of a risk management system;
(d)Article 28(1) insofar as it relates to obligations set out in—
(i)the second paragraph of Article 107(1) of the 2001 Directive,
(ii)the first sentence of Article 107(4) of the 2001 Directive, or
(iii)Article 107(5) of the 2001 Directive;
(e)Article 28(2) insofar as it relates to the obligation set out in the third paragraph of Article 107c(4) of the 2001 Directive; and
(f)Article 28b(1) insofar as it relates to prohibitions or obligations set out in—
(i)Article 107m(3) to (6) of the 2001 Directive,
(ii)the second paragraph of Article 107n(3) of the 2001 Directive, or
(iii)the last sentence of Article 107o of the 2001 Directive.
(7) This regulation is subject to regulation 212 (transitional arrangements).
Textual Amendments
F1Word in reg. 210(3)(a) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 24
F2Word in reg. 210(6)(a) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 24
Marginal Citations
M1Article 16(4), second paragraph, of Regulation (EC) No 726/2004 (“the Regulation”) imposes an obligation identical to that set out in Article 23(4), second paragraph, of the 2001 Directive; Article 23(4), second paragraph, of the 2001 Directive is transposed at regulation 182(5).
M2Article 20(8) of the Regulation applies Article 107i of the 2001 Directive, which in turn applies Articles 107j and 107k of the 2001 Directive; Article 107k(2) second paragraph is implemented in regulation 197(3).
M3Article 21(1) of the Regulation, first paragraph, cross-refers to obligations set out in Article 104 of the 2001 Directive, implemented in regulation 182 and 185; Article 21(1), second paragraph, and 21(2) of the Regulation are similar in effect to Article 104a of the 2001 Directive, implemented in regulation 183.
M4Article 22 of the Regulation cross-refers to obligations set out in Article 106a(1) of the 2001 Directive; Article 106a(1) is implemented in regulation 205.
M5Article 28(1) and (2) of the Regulation cross-refers to obligations set out in Articles 107, 107a, 107b and 107c of the 2001 Directive; those Articles are implemented in regulations 185, 186, 187, 188, 191, 192 and 193; Article 28(5) of the Regulation applies Articles 107e to 107g of the 2001 Directive; Article 107g of the 2001 Directive is implemented in regulation 194.
M6Article 28a(3) of the Regulation imposes an obligation identical to that set out in the first sentence of Article 107h(3) of the 2001 Directive; Article 107h(3) first sentence is implemented in regulation 190.
M7Article 28b(1) of the Regulation cross-refers to prohibitions and obligations set out in Articles 107m, 107n, 107o, 107p and 107q of the 2001 Directive; those Articles are implemented in regulations 198, 199, 200, 201 and 202; Article 107n(1) and the first paragraph of Article 107n(3), implemented in regulation 199(2) and (6), are excluded as they are enforced otherwise than by way of criminal offence.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
Yr Offeryn Cyfan you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Yr Offeryn Cyfan heb Atodlenni you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Rhestrau you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys