Clause 3 Flashcards
3.1 When must a medicine not be promoted?
A medicine must not be promoted prior to the grant of the marketing authorization which permits its sale or supply.
3.2 What must the promotion of a medicine be in accordance with the terms of? What must it not be inconsistent with?
The promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics.
(3 Marketing Authorisation) The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided what?
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.
(3 Conditional Marketing Authorizations)
If a medicine has been granted a conditional marketing authorization then it can be promoted in accordance with what?
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.
(3 Early Access to Medicines Scheme)
Medicines that are approved for the Early Access to Medicines Scheme (EAMS) meet one of the following two conditions. What are they?
Either the medicine does not have a marketing authorization or the medicine has a marketing authorization but no licence for the specific indication.
(3) Why must medicines or indications that are approved for EAMS not be promoted?
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.
(3 Compassionate Use)
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 what?
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.
(3 Promotion at International Meetings)
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.
(3.1 Advance Notification of New Products or Product Changes which May Significantly Affect Expenditure)
Why is there a need for NHS organisations and others involved in the purchase of medicines to receive advance information about the introduction of new medicines, or changes to existing medicines?
The need to estimate their likely budgets in advance as information about the introduction of new medicines, or changes to existing medicines, may significantly affect their level of expenditure , including that which might arise from changes in the patient pathway and/or service delivery.
(3) 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), what would be a breach of the Code?
For them to be promoted.
(3) Companies wishing to provide advance notification must ensure that information is also provided wherever possible for inclusion in what? national horizon scanning databases.
The national horizon scanning databases.
(3) 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
(3) Non-promotional information can be provided as advance notification but it 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.
(3.2 Unauthorized Indications)
The promotion of indications not covered by the marketing authorization for a medicine is what, by this clause.
The promotion of indications not covered by the marketing authorization for a medicine is prohibited by this clause.
