Chwilio Deddfwriaeth

The Human Medicines Regulations 2012

Status:

Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).

Urgent action

This adran has no associated Memorandwm Esboniadol

196.—(1) This regulation applies where the licensing authority forms the view that as a result of the evaluation of data resulting from pharmacovigilance activities urgent action is necessary in connection with—

(a)suspending or revoking an authorisation or registration of a medicinal product or class of medicinal products;

(b)prohibiting the supply of a medicinal product or class of medicinal products;

(c)refusing the renewal of an authorisation or registration of a medicinal product;

(d)receiving information from the holder that, on the basis of safety concerns, the holder has interrupted the sale or supply, or offer for sale or supply, of the product or that the holder has taken action to have the product’s authorisation or registration cancelled or that the holder intends to do so; or

(e)considering whether the terms of the authorisation or registration of a medicinal product or class of medicinal products should be varied to include a new contra-indication, an alteration of a recommended dose or a restriction to the therapeutic indications.

(2) The licensing authority must provide information about the urgent action it considers necessary by the end of the day following the day on which the view under paragraph (1) was formed to—

(a)the competent authorities of the EEA States other than the United Kingdom;

(b)the EMA; and

(c)the European Commission.

(3) When informing the EMA under paragraph (2), the licensing authority must make available to the EMA in relation to the medicinal product or class of medicinal products—

(a)all relevant scientific information at its disposal; and

(b)any assessment it has carried out.

(4) Where the EU urgent action procedure does not apply in relation to the medicinal product or class of medicinal products referred to in paragraph (1), the licensing authority—

(a)must inform the holder that it has taken action under paragraph (2); and

(b)may take such steps as it sees fit to address the safety concerns.

(5) Where the EU urgent action procedure does apply in relation to the medicinal product or class of medicinal products referred to in paragraph (1), the licensing authority may where the conditions in paragraph (6) are met—

(a)suspend the authorisation or registration of the medicinal product or the authorisations and registrations for the class of medicinal products referred to in paragraph (1) (as the case may be); or

(b)prohibit its or their use within the United Kingdom.

(6) The conditions in this paragraph are that—

(a)urgent action is necessary to protect public health; and

(b)an agreement under Article 107k of the 2001 Directive in respect of the medicinal product or class of medicinal products has not been reached.

(7) Where the licensing authority takes action under paragraph (5), it must by the end of the next working day after the day on which the action is taken inform of the reasons for the action the following—

(a)the European Commission;

(b)the EMA; and

(c)the competent authority of each EEA State other than the United Kingdom.

(8) In this regulation “the EU urgent action procedure” means the procedure under Articles 107j and 107k of the 2001 Directive.

Yn ôl i’r brig

Options/Help

Print Options

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?

Close

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.

Close

Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

Close

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.

Close

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
Close

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.
Close

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