1.5.14 Essential information in professional advertising

RULE 41: Essential information is required to be provided in all advertising materials directed wholly or mainly at persons qualified to prescribe or supply except for those materials that are specifically exempt from this requirement.

There are two forms of essential information that can be used in different circumstances: long form and short form.

Long form

The long form essential information must be included for:

  • Training material for P medicines (for GSL medicines essential information is required, the long form is recommended)
  • Advertisements for innovative pharmacy only medicines exceeding 420cm2 (NB. 310.8cm2 equates to A5) and all loose inserts for these medicines during the first two years after lauch and where mandated by the MHRA (eg. through a requirement in the Risk Management Plan (RMP) of the product)

NB. For advertisements for innovative pharmacy only medicines that are less than 420cm2 that are an integral part of a larger publication (not issued in the form of a loose insert), the short form essential information is acceptable.

Short form

The short form essential information must be included in:

  • Abbreviated advertisements (no larger than 420cm2 and an integral part of a larger publication ie. not issued in the form of a loose insert)
  • Advertisements for non-innovative pharmacy only medicines and medicines classified as general sales including advertisements for products with tradtional herbal registrations. NB If preferred the long form essential information can be included instead of the short form

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Long form requirements:

Identification

  • name of the product
  • a list of the active ingredients, which must be placed immediately adjacent to the most prominent display of the product name. The font size must be such that the lower case letter ‘a’ measures at least 2 mm in height, which equates to font size 10 for the majority of fonts. Where the name on pack is the most prominent product name in the advertisement, front facing pack shots (not oblique) may satisfy this requirement provided they meet the required font size (Please refer to rule 42, on legibility)
  • product licence number
  • name and address of the product licence holder, or the part of the product licence holder’s business responsible for the supply of the product
  • supply classification (P, GSL)

Use of the product

  • indications: one or more of the indications for the use of the product (including the traditional use statement when required)
  • side effects, precautions and relevant contra-indications: a succinct
  • statement describing the side effects, precautions and contra-indications related to the indications shown
  • dosage and method of use: a succinct statement describing how and when the product should be used. The method of administration should be included if it is not obvious
  • warnings: any warning statements required for advertisements as a condition of the Marketing Authorisation
  • cost: the cost (excluding VAT) of a specified pack size, specified quantity or recommended daily dose of the product. It should be clear whether the quoted price refers to trade or retail (both are acceptable)*
  • date: the date when the essential information was drawn up or revised should be included if the advertisement is not bound into a dated publication.

*There is an exception for audio-visual advertisements and advertisements in a journal printed in the UK but with a circulation outside the UK of more than 15% of its total circulation.

Short form requirements:

Identification

  • name of the product
  • a list of the active ingredients, which must be placed immediately adjacent to the most prominent display of the product name. The font size must be such that the lower case letter ‘a’ measures at least 2mm in height, which equates to font size 10 for the majority of fonts. Front facing pack shots (not oblique) may satisfy this requirement provided they meet the required font size (please refer to rule 42 on legibility)
  • name and address of the product licence holder, or the part of the product licence holder’s business responsible for the supply of the product
  • supply classification (P, GSL)

Use of the product

  • indications: one or more of the indications for the use of the product (including the traditional use statement when required)
  • “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: [direct single-click website link]”

Digital advertising requirements

For advertisements on digital platforms the long form essential information should be included however, these requirements can be met by the inclusion of a direct single-click link to the information listed above. Cost and legal classification are not included in the SmPC but must still be included in the advertisement or linked information.

Traditional Use Statement

For Traditional Herbal Medicines (THMs), the statement ‘Traditional herbal medicinal product for use in [specify one or more of the indications for the product consistent with the terms of the registration] exclusively based on long-standing use as a traditional remedy.’ This statement must be sufficiently prominent to ensure that recipients of the advertisment understand that the product is a THM.

Adverse event reporting information

Whilst there is no requirement to include information on adverse event reporting within advertising materials, it may be helpful to do so. Advertisers who choose to include this information may wish to use wording similar to: ‘Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to [relevant pharmaceutical company]’.

Note: When promoting medicines for use during pregnancy, member companies should refer to rule 18 and to the MHRA’s guideline ‘Medicines which are promoted for use during pregnancy’.

Circumstances in which essential information is required

Essential information must be included in the following circumstances (please also refer to ‘Buyers and shopkeepers’ below):

  • where product claims1 are made. (This does not include those which can be seen on a genuine pack shot)
  • where direct or implied product claims1 are included in the form of artwork. (This does not include the artwork on a genuine pack shot)
    where direct or implied product claims1 are included in the form of questions and answers, such as in a competition
  • where promotional items used at exhibitions include product claims1. (The essential information may be available either on the items themselves or at the stand.)
  • where ‘post-it notes’ or calendars bear product claims1. (The essential information does not need to be included on every page, provided it is supplied on the cover or back page.)
  • on envelopes addressed to persons qualified to prescribe of supply. (Envelopes may have a claim or a brand name without necessitating the inclusion of essential information. If both a claim and a brand name are included the essential information must be present.)
  • in factual and informative announcements that include medicinal claims1. This does not include those that can be seen on a true representation of a pack, or as a straightforward representation of the indications (please refer to section 1.3.4). Factual and informative announcements include documents such as trade catalogues, price lists and planned-list order forms (PLOFs).

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Circumstances in which essential information is not required

Essential information is not required in the following circumstances:

  • in advertisements that do not contain product claims1 (other than those that can be seen on a genuine pack shot). (For further information, please refer to section 1.3.3.)
  • on items intended wholly or mainly for consumers. These may be shown to persons qualified to prescribe or supply without triggering the requirement for professional essential information
  • on promotional aids, provided they feature no more than the product name or a reasonable abbreviation thereof, and trade mark protection. (Please refer to rule 45 for further information.)
  • on dummy packs used for display purposes. (However, essential information may be required where additional advertising claims are added and where such claims are aimed at persons qualified to prescribe and supply.)
  • in factual and informative announcements that do not include product claims1 other than those that can be seen on a true representation of a pack, or as a straightforward representation of the indications (please refer to section 1.3.4). Factual and informative announcements include documents such as trade catalogues, price lists and planned-list order forms (PLOFs)

Note on planned-list order forms (PLOFs)

Whether the essential information is needed on a PLOF will depend on who the target audience is (persons with or without a healthcare qualification) and on what claims are included. Table 2 can be used as a guide to whether essential information should be included.

1 Please refer to section 5.1, for a definition of ‘product claims’.

RULE 42: The essential information required in professional advertising must be prominent and clearly legible.

Advertisers are responsible for ensuring that the essential information is clearly legible. The information below describes the minimum requirements in terms of font size. However, there are several additional factors that affect legibility; attention should also be paid to issues such as number of characters in a line, line spacing, type style, print quality, contrast between text and background and identification of headings.

Font size of active ingredients

Part 14 of the Human Medicines Regulations 2012 requires that the active ingredients are listed immediately next to the most prominent display of the product name. The most prominent display of the product name is subjective. However, where a pack shot is featured, this is generally considered to be the most prominent display and a list of all actives should be placed adjacent to this.

The list of active ingredients should be stated in a font in which the lower case letter ‘a’ measures at least 2mm in height. (This equates to font size 10 for the majority of fonts.)

Other items of essential information

For all other items of essential information, where an advertisement is intended to be read in close proximity a lower case letter ‘a’ must measure at least 1mm in height. For the majority of fonts, this equates to font size 8. (This guidance does not apply to active ingredients.)

No set font size is required for essential information on items, such as posters, that will be read at a distance. It is the advertiser’s responsibility to ensure that all of the essential information is clearly legible. Careful consideration must be given to the distance from which the advertisement will be viewed.

Positioning of essential information

The essential information must be horizontal.

It is not acceptable to have the information upside down in relation to the advertisement, printed in a spiral fashion, around the outside of the advertisement or in any manner that makes reading the information difficult.

Essential information should be contained within the advertisement or, in the case of a full A4 advertisement or similar, on a facing page, provided there is no intervening editorial or pictorial, etc. With regard to website banner advertising, the essential information may be provided by adding a direct and prominent link to the necessary information.

In the case of multiple-page advertisements, information is not required on each page provided there is a clear reference on the front page referring the reader to where the information can be found. This is only applicable where the advertisement is on consecutive pages with no intervening editorial. The reference must measure at least 1mm in height. For the majority of fonts, this equates to font size 8.

Essential information needs to appear only once. For example, if a pack shot includes the name and indications in a legible manner there is no requirement to repeat the name and indications elsewhere.

RULE 43: In the case of audio-visual material, such as films, video recordings,etc., and interactive data systems, the essential information must be provided in written form. This may be provided either by way of a document that is made available to all persons to whom the material is shown or sent, or by inclusion in the audio-visual recording or the interactive data system.

Audio-visual advertisements and advertisements on interactive systems require the full essential information to be included and are not eligible for the inclusion of abbreviated essential information.

It is acceptable to provide the essential information audibly as an addition to the written form, but not instead of the written form.

RULE 44: In the case of audio material consisting of sound only, the essential information must be provided by way of a document that is made available to all persons to whom the material is played or sent.

Audio advertisements require the full essential information to be included. They are not eligible for exemption from the requirement to include full essential information. It is acceptable to provide the essential information audibly as an addition to the written form, but not instead of the written form.

RULE 45: Promotional aids are not required to comply with the requirements to include essential information, provided they feature no more than the product name or reasonable abbreviation thereof and the trade mark protection.

Promotional aids are items that have a purpose other than to promote a medicine but which display a product name as a reminder. Examples include pens, mugs, coasters, note pads and mouse mats. Promotional aids are exempt from the requirement to include essential information, as set out in rule 41, if they bear no more than a product name, a reasonable abbreviation thereof or an umbrella brand name and a trade mark protection. However, if any additional information is included, such as a strap line or a visual representation of a claim, the item will need to carry essential information.

The list of acceptable gifts in rule 33 may also be used as guidance on the provision of promotional aids. However, items not considered to be relevant to the practice of medicine or pharmacy are not excluded. For example, depending upon the circumstances balloons may be used as promotional aids. Promotional aids intended for persons qualified to prescribe or supply should cost no more than £6 excluding VAT. Advertisers should also take into account the perceived value, which is the price at which recipients could purchase the item themselves.