- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (09/02/2019)
- Gwreiddiol (a wnaed Fel)
Version Superseded: 06/11/2020
Point in time view as at 09/02/2019.
The Human Medicines Regulations 2012, Cross Heading: Advertising to persons qualified to prescribe or supply etc is up to date with all changes known to be in force on or before 26 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
294.—(1) This regulation applies to an advertisement that—
(a)relates to a medicinal product; and
(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.
(2) A person may not publish an advertisement to which this regulation applies unless—
(a)subject to paragraph (3), it contains the particulars set out in paragraphs 1 to 8 of Schedule 30; and
(b)in the case of a written advertisement, it is in accordance with paragraph 9 of that Schedule.
[F1(2A) By way of an exception to paragraph (2), in the case of an advertisement that relates to a pharmacy medicine or a medicinal product subject to general sale, a person may publish the advertisement if it contains—
(a)the particulars set out in paragraphs 2 to 6 of Schedule 30; and
(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by
(c)a website address that corresponds to that statement.
(2B) The website at the address mentioned in paragraph (2A)(c) must make available—
(a)the particulars set out in paragraphs 1 to 8 of Schedule 30; or
(b)a copy of the summary of the product characteristics.]
(3) In the case of an advertisement that is not a written advertisement, those particulars may alternatively be made available in written form to all persons to whom the advertisement is made available.
(4) This regulation—
(a)does not apply to an advertisement to which regulation 295 (abbreviated advertisements) applies;
(b)does not apply to oral representations made by medical sales representatives to which regulation 299 (medical sales representatives) applies; and
(c)is subject to regulations 296 (exception for advertisements intended as a reminder) and 301 (advertisements for registered homoeopathic medicinal products).
Textual Amendments
F1Reg. 294(2A)(2B) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 24(2) and reg. 294(2A)(2B) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 24(2)
295.—(1) This regulation applies to an abbreviated advertisement that—
(a)relates to a medicinal product; and
(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.
(2) A person may not issue an abbreviated advertisement to which this regulation applies unless it contains—
(a)the particulars set out in paragraphs 2 to 6 of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply);
(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by
(c)a web site address that corresponds to that statement; and
(d)the name and address of the holder of the marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product, or the business name and address of the part of the holder's business that is responsible for its sale or supply.
(3) The web site at the address mentioned in sub-paragraph (2)(c) must make available—
(a)the particulars set out in Schedule 30; or
(b)a copy of the summary of the product characteristics.
(4) In this regulation, “abbreviated advertisement” means an advertisement, other than a loose insert, that—
(a)does not exceed 420 square centimetres in size; and
(b)appears in a publication sent or delivered wholly or mainly to persons qualified to prescribe or supply medicinal products.
(5) This regulation is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).
296. Regulations 291 (form and content of advertisement) and 294 (general requirements) do not apply to an advertisement relating to a medicinal product if the advertisement is intended solely as a reminder of the product and consists solely of—
(a)in the case of a product other than a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name or trademark; and
(b)in the case of a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name, invented name or trademark or the scientific name of the stock or stocks from which it is derived.
297.—(1) A person may not as part of the promotion of a medicinal product send or deliver any written material to a person qualified to prescribe or supply medicinal products unless the material—
(a)contains particulars in accordance with all the paragraphs of Schedule 30; and
(b)states the date on which it was drawn up or last revised.
(2) A person may not include any information in written material to which paragraph (1) applies unless it—
(a)is accurate;
(b)is up-to-date;
(c)can be verified; and
(d)is sufficiently complete to enable the recipient to form an opinion of the therapeutic value of the product to which it relates.
(3) A person may not include any illustrative material in written material to which paragraph (1) applies unless—
(a)the illustrative material is accurately reproduced; and
(b)the written material indicates the precise source of the illustrative material.
(4) In this regulation “illustrative material” means a quotation, table or any other illustrative material taken from a medical journal or other scientific work.
298.—(1) A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.
(2) Condition A is that the recipient—
(a)is qualified to prescribe medicinal products; and
(b)receives the sample for the purpose of acquiring experience in dealing with the product in question.
(3) Condition B is that the sample is supplied to the recipient—
(a)on an exceptional basis; and
(b)in response to a request from, and signed and dated by, the recipient.
(4) Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.
(5) Condition D is that the sample—
(a)is no larger than the smallest presentation of the product that is available for sale in the United Kingdom;
(b)is marked “free medical sample – not for resale” or bears a similar description; and
(c)is accompanied by a copy of the summary of the product characteristics.
(6) Condition E is that the sample does not contain—
(a)a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or
(b)a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).
(7) Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.
299.—(1) This regulation applies in relation to the promotion by a medical sales representative of medicinal products to persons qualified to prescribe or supply such products.
(2) During each visit for promotional purposes the representative must give to, or have available for, each person visited a copy of the summary of the product characteristics for each product promoted.
(3) The representative must report all information, with particular reference to any adverse reactions, that—
(a)is received from persons visited for promotional purposes; and
(b)relates to the use of a product promoted,
to the scientific service established in accordance with regulation 281(2) by the holder of the marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation for the product.
300.—(1) A person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit unless it is—
(a)inexpensive; and
(b)relevant to the practice of medicine or pharmacy.
(2) A person may not provide hospitality at a meeting or event held for the purposes of the promotion of a medicinal product unless—
(a)the hospitality is strictly limited to the main purposes of the meeting or event; and
(b)the person to whom it is provided or offered is a health care professional.
(3) Nothing in this regulation shall prevent any person providing hospitality at an event held for purely professional or scientific purposes provided that—
(a)the hospitality is strictly limited to the main scientific objective of the event; and
(b)the person to whom it is provided or offered is a health care professional.
(4) A person qualified to prescribe or supply medicinal products may not solicit or accept any gift, pecuniary advantage, benefit or hospitality that is prohibited by this regulation.
(5) In this regulation “hospitality” includes—
(a)sponsorship of a person's attendance at a meeting or event; and
(b)the payment of travelling or accommodation expenses.
(6) This regulation does not apply in relation to measures or trade practices relating to prices, margins or discounts that were in existence on 1st January 1993.
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?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
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?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
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?
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?
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?
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.
Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
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