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Novo Case (ABPI Code of Practice (Scope: This code of practice only…
Novo Case
ABPI Code of Practice
Scope: This code of practice only applies to promotion material (this ranges from rep material, direct advertising, supply of samples)
Market extension (increase market share within the industry) is allowed as a reason for increasing/using promotional material
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Market Authorisation: promotional material must only be used once the product that is being promoted has market authorisaton
this might pose as a problem when at international meetings - as you might be going to a meeting with the purpose of discussing changes/ promotions but certain countries there or the country you are in, you do not have market authorisation
there are a few conditions: the meeting must be significantly international, relevant and proportional to the purpose of the meeting, clearly communicated that certain markets lack authorisation, providing sample promotion material for those countries which is not relevant to that country, and any material must be certified (as specified by the Code)
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There is a requirement to provide advanced notification to the payers/policy makers (e.g. NHS) if the product being promoted will affect their ependitures.
this information should be provided before the promotional material is developed and during the process of market authorisation, should also be included in the horizon database (NHS, latest news on emerging technology)
Should provide non-promotional information as a way to inform the payers. This would be a description of key changes in terms of new active substance, or new substance prepared in a new way or significant addition to existing range or novel application
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Out of scope: promotional material for professionals that aims to promote the sale of OTC (whereas if it aims for the prescription of OTC then that's ok). Labelling is also out of scope as this is not considered promotoinal material
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Novo Company
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Changing Diabetes: platform that aims to break the Rules of Halves for diabetes - have developed several key programmes - in children, pregnancy.
Changing diabetes in children - teaching children how to successfully manage their condition and live healthy lives
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