- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
The Human Medicines Regulations 2012
You are here:
- Offerynnau Statudol y Deyrnas Unedig
- 2012 No. 1916
- PART 13
- CHAPTER 1
- Enforcement and offences
Pa Fersiwn
Nodweddion Uwch
- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
- Dangos Llinell Amser Newidiadau
Changes over time for: Cross Heading: Enforcement and offences
Alternative versions:
Changes to legislation:
There are currently no known outstanding effects for the The Human Medicines Regulations 2012, Cross Heading: Enforcement and offences.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Enforcement and offencesU.K.
Offence relating to packaging and package leaflets [F1in Great Britain]: holder of authorisation etcU.K.
268.—(1) This regulation applies to the holder of a [F2UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply [F3, in Northern Ireland], a medicinal product to which the authorisation, certificate or registration relates.
(2) A person to whom this regulation applies is guilty of an offence if—
(a)a package or package leaflet relating to the product does not comply with the applicable requirements of this Part F4... or [F5regulation 50C(4), 50D(8) or 58A(2)(b)]; or
(b)the product is not accompanied by a package leaflet when one is required by virtue of this Part.
Textual Amendments
F1Words in reg. 268 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 268(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 268(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in reg. 268(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in reg. 268(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
[F6Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etcU.K.
268A.—(1) This regulation applies to the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates.
(2) A person to whom this regulation applies is guilty of an offence if—
(a)a package or package leaflet relating to the product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or
(b)the product is not accompanied by a package leaflet when one is required by virtue of this Part.]
Textual Amendments
F6Reg. 268A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207A (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 162); 2020 c. 1, Sch. 5 para. 1(1)
Offences relating to packaging and package leaflets [F7in Great Britain]: other personsU.K.
269.—(1) This regulation applies to a person, other than the holder of a [F8UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business [F9carried on by that person,] sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply [F10, in Great Britain].
(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, [F11in Great Britain] knowing or having reasonable cause to believe—
(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part F12... or [F13regulation 50C(4), 50D(8) or 58A(2)(b)]; or
(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.
Textual Amendments
F7Words in reg. 269 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(a)); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in reg. 269(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in reg. 269(1) inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 7 and words in reg. 269(1) inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 7
F10Words in reg. 269(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); ; 2020 c. 1, Sch. 5 para. 1(1)
F11Words in eg. 269(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(2A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(c)); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in reg. 269(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in reg. 269(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
[F14Offences relating to packaging and package leaflets in Northern Ireland: other personsU.K.
269A.—(1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply in Northern Ireland.
(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Northern Ireland knowing or having reasonable cause to believe—
(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or
(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.]
Textual Amendments
F14Reg. 269A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 208A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 164)
Non-compliance with requirements of this PartU.K.
270.—(1) If the holder of a [F15UK marketing authorisation, EU marketing authorisation,] Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.
(2) If the holder fails to comply with the notice, the licensing authority may suspend the [F16UK marketing authorisation, EU marketing authorisation,] Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.
(3) A person who fails to comply with a notice under this regulation is guilty of an offence.
Textual Amendments
F15Words in reg. 270(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
F16Words in reg. 270(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
Offences: penaltiesU.K.
271. A person who is guilty of an offence under regulation [F17268, 268A, 269, 269A] or 270 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.
Textual Amendments
F17Words in reg. 271 substituted (31.12.2020) by S.I. 2019/775, reg. 209A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 166)
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Part
PrintThe Whole Chapter
PrintThis Cross Heading only
You have chosen to open The Whole Instrument
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?
You have chosen to open The Whole Instrument as a PDF
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
You have chosen to open The Whole Instrument without Schedules
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?
You have chosen to open The Whole Instrument without Schedules as a PDF
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
You have chosen to open yr Offeryn Cyfan
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?
You have chosen to open yr Offeryn Cyfan heb Atodlenni
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?
You have chosen to open Schedules only
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?
Mae deddfwriaeth ar gael mewn fersiynau gwahanol:
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.
Gweler y wybodaeth ychwanegol ochr yn ochr â’r cynnwys
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.
Dewisiadau Agor
Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd
Memorandwm Esboniadol
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.
Rhagor o Adnoddau
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:
- y PDF print gwreiddiol y fel deddfwyd fersiwn a ddefnyddiwyd am y copi print
- rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
- manylion rhoi grym a newid cyffredinol
- pob fformat o’r holl ddogfennau cysylltiedig
- slipiau cywiro
- dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Asesiadau Effaith
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:
- Why the government is proposing to intervene;
- The main options the government is considering, and which one is preferred;
- How and to what extent new policies may impact on them; and,
- The estimated costs and benefits of proposed measures.
Llinell Amser Newidiadau
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.
Rhagor o Adnoddau
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:
- y PDF print gwreiddiol y fel gwnaed fersiwn a ddefnyddiwyd am y copi print
- slipiau cywiro
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys
- rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
- manylion rhoi grym a newid cyffredinol
- pob fformat o’r holl ddogfennau cysylltiedig
- dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.