- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
There are currently no known outstanding effects for the The Health Service Products (Provision and Disclosure of Information) Regulations 2018, Section 27.
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.
27.—(1) This regulation applies where the Secretary of State has reasonable grounds to suspect that a presentation of English health service medicine is, in a particular month, available for distribution or supply to English NHS chemists at a price which exceeds the listed price.
(2) Where this regulation applies, the Secretary of State may, by request in writing, require any of the following UK producers to provide the information mentioned in paragraph (3) for the relevant presentation—
(a)a manufacturer of the presentation,
(b)a person who distributes the presentation (whether by wholesale dealing or otherwise), or
(c)an importer of the presentation.
(3) The information is—
(a)the quantity, by relevant pack size, of the presentation which is available for distribution or supply by the producer in England,
(b)the net price or net prices, or a reasonable estimate of the net price or net prices, at which the producer would offer to distribute or supply those pack sizes in England,
(c)the quantity, by relevant pack size, of any branded equivalent which is available for distribution or supply by the producer in England, and
(d)the net price or net prices, or a reasonable estimate of the net price or net prices, at which the producer would offer to distribute or supply those pack sizes in England.
(4) A producer who is given a written request under paragraph (2), must comply with the request within the period of two working days beginning—
(a)with the day on which producer is given the request, if that day is a working day;
(b)otherwise, with the first working day after the day on which the notice is given to the producer.
(5) In this regulation—
“branded equivalent”, in relation to a presentation of English health service medicine, means a particular form of medicinal product—
to which a brand name has been applied that enables the medicine to be identified without reference to the common name, but
which has the same—
active ingredient or ingredients,
strength,
physical form,
unit dose (if applicable),
method of administration (if applicable),
freeness (if applicable), and
type of packaging,
as the presentation;
“English health service medicine” means a medicinal product used to any extent for the purposes of the health service continued under section 1(1) of the 2006 Act;
“listed price”, in relation to a presentation of English health service medicine, means the price listed for that medicine in Part VIII of the Drug Tariff (England);
“net price”, in relation to a presentation, means the price after the deduction of—
all discounts and payments, and
the value of all payments or benefits in kind;
“relevant pack size”—
in relation to a presentation of English health service medicine which—
is a presentation of unbranded generic health service medicine, and
is a liquid or a topical preparation or is in tablet or capsule form,
means any pack size which does not exceed the maximum pack size;
in relation to any other presentation of English health service medicine or a branded equivalent, means any pack size.
(6) For the purposes of this regulation—
(a)the definition of “presentation” in paragraph 2 of Schedule 1 applies as if any reference to pack size were omitted, and
(b)for the purpose of determining whether there is price listed in Part VIII of the Drug Tariff (England), any pack size specified in that Part is to be disregarded.
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.
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