1.6 PAGB Professional Code for Medicines advertising checklist
The list below is intended as a reminder of some of the elements you should consider when reviewing professional advertising. It is not a complete list of all aspects to be considered.
1. Does the item fall under the PAGB Professional Code for Medicines?
The following do not fall under the PAGB Professional Code for Medicines:
- items that do not mention a medicine by name
- items that mention a medicine by name but contain no product claims other than those featured on a genuine pack shot (sections 1.3.1 and 2.1)
- factual and informative announcements that only refer to prices, adverse drug reactions, new labelling and new pack sizes, etc.
- items promoting the prescribing of a medicine
- items relating to products, such as medical devices, food supplements and cosmetics, that are not subject to a Marketing Authorisation
- items that are a response to a specific enquiry or comment by a person qualified to prescribe or supply.
- (For further information on materials that do and do not fall under the PAGB Professional Code for Medicines please refer to sections 1.2 and 1.3.)
2. Ensure the advertising complies with the PAGB Professional Code for Medicines.
The following items should be checked:
- the medicine should not be advertised prior to the issue of the Marketing Authorisation (rule 2)
- the item should be factual, not misleading and in line with the SmPC (rules 3 and 4)
- the material should encourage the responsible use of medicines and should not undermine current healthy-lifestyle advice (rules 5 and 6)
- the activity should respect the status of the recipient and be reputable, and all claims should be supportable (rules 5 and 9)
- the material may only refer to the MHRA, EMA or to the Licensing Authority in order to state that the product is licensed (rule 7)
- if ‘new’ is used, the medicine should have been launched within the UK for no longer than one year (rule 13)
- if the product is said to be unique, there should be an explanation as to why it is unique (rule 14)
- if ‘safe’ is used, it should be qualified (rule 15)
- if use in pregnancy is mentioned, rule 18 must be complied with
- if the product is said to be ‘herbal’ or ‘natural’, rules 19 to 21 must be complied with,
- if comparisons are used, they must comply with rules 22 to 26
- any quotations must be up to date, must comply with all other rules of the Code and must be in line with current medical opinion (rule 27)
- references must be included for all graphs, tables, sales claims and all product claims that are not in the SmPC (section 1.5.7)
- for innovative P medicines if the is over 420cm² ensure it contains the long form essential information. For GSL and non-innovative P medicines the short form essential information is required. (rule 41)
- if the item is under 420cm² and is part of a bound publication, ensure it contains the short form essential information (rule 41)
- for innovative P medicines if the item is under 420cm² but not part of a bound publication, ensure it contains the long form essential information. For GSL and non-innovative P medicines the short form essential information is required (rule 41)
- if the item is audio or audio-visual, ensure the essential information is available in written form (rules 43 and 44)
- if the promotion involves a gift or prize, ensure it complies with rule 33
- if the promotion involves hospitality, ensure it complies with rule 34
- if representatives of the company are involved, ensure it complies with rules 37 to 40,
- if sampling is involved, ensure it complies with rule 36
- if the item involves free packs, ensure this complies with sections 1.3.10, 1.3.12 – 1.3.14 and 1.5.12 as applicable.
- Training materials require essential information. In all cases the long form essential information is recommended, for innovative P it is mandatory (Rule 41)
- companies should ensure that those involved in ensuring compliance with the PAGB Professional Code for Medicines have a thorough working knowledge of the Code
- companies should ensure that copies of the PAGB Medicines Advertising Codes are provided to all relevant personnel and that these personnel are encouraged to attend a PAGB Medicines Advertising Workshop. This includes company representatives and agency staff
- representatives should be trained to a reasonable level with regard to the products they are promoting and with regard to the relevant aspects of the PAGB Professional Code for Medicines
- companies must endeavour to make internal procedures sufficient to ensure compliance with any rulings regarding breaches of the PAGB Professional Code for Medicines
- companies should ensure that procedures are in place to disseminate any information that PAGB may provide in relation to the Code. For example, personnel involved in ensuring compliance with the PAGB Professional Code for Medicines should be included on PAGB’s advertising mailing list.
- brand specific training materials for P medicines must include the long form essential information (for GSL products short form essential information is required, however the long form is recommended).