- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
192.—(1) This regulation applies in relation to medicinal products granted—
(a)a marketing authorisation pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or
(b)a traditional herbal registration.
(2) In the following paragraphs of this regulation—
“authorisation or registration” means a marketing authorisation to which paragraph (1)(a) applies or a traditional herbal registration;
“the holder” means the holder of a marketing authorisation to which paragraph (1)(a) applies or of a traditional herbal registration; and
“product” means a product to which a marketing authorisation referred to in paragraph (1)(a) or a traditional herbal registration relates.
(3) The holder must submit PSURs in relation to the product to the EMA in accordance with paragraph (5)—
(a)where requested to do so by the licensing authority in accordance with paragraph (4); or
(b)in the case of a product to which paragraph (1)(a) applies, where it is a condition to which the marketing authorisation for the product is subject by virtue of regulations 59 (conditions of UK marketing authorisation: general) or 60 (conditions of UK marketing authorisation: exceptional circumstances) to do so.
(4) The licensing authority may request the holder to submit PSURs where—
(a)it has concerns relating to the product’s pharmacovigilance data; or
(b)it considers there is a lack of PSUR data relating to an active substance of the product after the authorisation or registration is granted.
(5) The submission of PSURs under paragraph (3) must be in accordance with—
(a)where the PSUR is submitted pursuant to a request under paragraph (3)(a), the terms of the request; and
(b)where the PSUR is submitted pursuant to a condition under paragraph (3)(b), the terms of the condition.
(6) Each PSUR must contain—
(a)summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation or registration for the product;
(b)a scientific evaluation of the risk-benefit balance of the product; and
(c)all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.
(7) For the purposes of paragraph (6)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation or registration for the product.
(8) Each PSUR must be submitted electronically.
(9) Where the licensing authority requests submission of PSURs under paragraph (3)(a), it must communicate a PSUR assessment report to the EMA as soon as is reasonably practicable after each report is received.
(10) In this regulation “PSUR assessment report” means a report which evaluates the information provided in a PSUR.
(11) This regulation is subject to regulation 212 (transitional arrangements).
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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