- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
193.—(1) Where products that are subject to different authorisations or registrations contain the same active substance or the same combination of active substances, the frequency and dates of submission may be amended and harmonised in accordance with—
(a)Article 107c(4) of the 2001 Directive; or
(b)paragraphs (2) to (4).
(2) The holder may, where one or more of the grounds in paragraph (3) is met, submit a request in relation to the product to the EMA—
(a)to determine an EU reference date; or
(b)to change the frequency of submission of the PSUR.
(3) The grounds in this paragraph are—
(a)reasons relating to public health;
(b)in order to avoid duplication of the assessment; or
(c)in order to achieve international harmonisation.
(4) The second paragraph of Article 107c(6) of the 2001 Directive has effect in relation to the submission and determination of a request under paragraph (2).
(5) Where the frequency or dates of submission of a PSUR are changed in accordance with Article 107c(4) or Article 107c(6) of the 2001 Directive, the holder must apply to vary the product’s authorisation or registration to reflect the new frequency or date of submission before the end of the period of six months beginning on the day after the change is made public by the EMA.
(6) In this regulation, “EU reference date” in relation to a product means—
(a)the date of the first marketing authorisation in the EEA of a medicinal product containing the same active substance or the same combination of active substances as that product; or
(b)if the date referred to in point (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations in the EEA for a medicinal product containing the same active substance or the same combination of active substances as that product.
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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.
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:
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