Clause 3 - Marketing Authorization

The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that any such information or activity does not constitute promotion which is prohibited under this or any other clause.

If a medicine has been granted a conditional marketing authorization then it can be promoted in accordance with the terms of that licence and is considered to meet the requirements of Clause 1.3 as having a marketing authorization. Material should clearly state at the outset that the medicine has a conditional marketing authorization.

Relevant information should be added wherever possible to national horizon scanning databases.

Medicines that are approved for the Early Access to Medicines Scheme (EAMS) meet one of the following two conditions. Either the medicine does not have a marketing authorization or the medicine has a marketing authorization but no licence for the specific indication. Medicines or indications that are approved for EAMS will not have either a marketing authorization for the medicine or for the indication and therefore must not be promoted.

Relevant information should be added wherever possible to national horizon scanning databases.

Companies sometimes decide to provide an unlicensed medicine or a medicine for use in an unlicensed indication on a compassionate use basis for those with an unmet medical need. Such availability is for companies to decide in line with relevant requirements. If these medicines do not have a relevant marketing authorization then they cannot be promoted.

The promotion of medicines at international meetings held in the UK may on occasion pose certain problems with regard to medicines or indications for medicines which do not have a marketing authorization in the UK although they are so authorized in another major industrialised country.

The display and provision of promotional material for such medicines is permitted at international meetings in the UK provided that the following conditions are met:

• the meeting must be a truly international meeting of high scientific standing with a significant proportion of the attendees from countries outside the UK in which the product is licensed
• the medicine or indication must be relevant and proportional to the purpose of the meeting
• promotional material for a medicine or indication that does not have a UK marketing authorization must be clearly and prominently labelled to that effect
• in relation to an unlicensed indication, UK approved prescribing information must be readily available for a medicine authorized in the UK even though it will not refer to the unlicensed indication
• the names must be given of countries in which the medicine or indication is authorized which must include at least one major developed country and it must be stated that registration conditions differ from country to country
• the material is certified in accordance with Clause 14, except that the signatories need certify only that in their belief the material is a fair and truthful presentation of the facts about the medicine.

NHS organisations and others involved in the purchase of medicines need to estimate their likely budgets in advance and there is a need for them to receive advance information about the introduction of new medicines, or changes to existing medicines, which may significantly affect their level of expenditure, including that which might arise from changes in the patient pathway and/or service delivery.

At the time this information is required, the medicines concerned (or the changes to them) will not be the subject of marketing authorizations (though applications will often have been made) and it would be in breach of the Code for them to be promoted. Companies wishing to provide advance notification must ensure that information is also provided wherever possible for inclusion in national horizon scanning databases. Non promotional information can be provided as advance notification but it must:

i) relate to:

(a) a product which contains a new active substance, or
(b) a product which contains an active substance prepared in a new way, such as by the use of biotechnology, or
(c) a product which is to have a significant addition to the existing range of authorized indications, or
(d) a product which is to have a novel and innovative means of administration

ii) only be directed to those responsible for making policy decisions on budgets and not those expected to prescribe.

iii) state whether or not a new medicine or a change to an existing medicine is the subject of a marketing authorization in the UK

iv) state the likely cost or savings and budgetary implications which must be such that they will significantly change the organisation’s likely expenditure (the budgetary implication might include the need for service redesign).

v) be factual and limited to that sufficient to provide an adequate but succinct account of the product’s properties; other products should only be mentioned to put the new product into context in the therapeutic area concerned

The information provided must not:

i) be promotional in style – product logos should be avoided but company logos may be used; the brand name of the product may be included in moderation but it should not be stylised or used to excess

ii) include mock up drafts of either summaries of product characteristics or package leaflets.

If requested further information may be supplied or a presentation made.

The promotion of indications not covered by the marketing authorization for a medicine is prohibited by this clause.