Key Topic 3: Important information for approval of assets
There are some very important pieces of information that you will need to provide to your signatories and to consider when preparing your material.
These are listed below – click on each for more information:
The purpose of the asset
The purpose of an asset is often a critical piece of information, although it may be obvious in many cases. For example it may be educational, it may be for internal training, to increase awareness of a particular disease, to provide budgetary information for payers, or to provide support for patients. Some assets, statements or claims may be approvable in one context but not in another and so you need to provide this information to your signatory. Assets can only used for the specific purpose for which they have been approved.
The target audience
Material should only be sent or distributed to people whose need for, or interest in it, can reasonably be assumed. If the material were to be used with a different audience for which it was not approved, it could breach regulations.
Most countries do not allow promotion of ‘prescription only medicines’ to the general public (including the media). An exception is the USA.
Your signatory will need to know which channels are to be used for distribution of media materials because there is a distinction in terms of what may be allowable for the financial industry, medical/scientific audiences and the consumer audiences.
You need to consider local approval for any locally specific channels you use e.g. if the global office use a US channel, the item is likely to need US approval and similarly for UK channels, UK approval is required.
The method of distribution of the asset
You should inform your signatory exactly how an asset is to be distributed or by what means it will reach its target audience. Vague information such as ‘digital’ is not sufficient. This is because other aspects such as the methods of targeting the intended audience, obligatory information and approving the asset in final form need to be considered. Assets may only be distributed by the approved means.
Obligatory Information on assets
Requirements in terms of obligatory information vary between countries so it is very important to establish which regulations and codes apply to each asset. In addition there may be specific requirements depending on the type of asset (e.g websites require cookie and legal notices). For press packs it is considered good practice to include the SmPC for any products mentioned, and a statement about the stage of development for any pipeline product.
Unique identifying number for each asset
Each asset has a unique identifying number that should appear on the asset itself. This number is used to identify the material and its supporting documentation. Different layouts of the same material (for example different sized advertisements for different journals with the same content) should have individual asset numbers.
Date of preparation and expiry
The date of preparation must appear on all material. In addition for global materials an expiry date is required (usually 12 months after the date of preparation).
Adverse event reporting
Some material requires a statement informing the reader that they should report adverse events to AstraZeneca and to the relevant regulatory authority, and providing them with details on how to do this. Generally a company telephone number would be provided. Global materials may direct the reader to their country specific contact details. Such materials include websites that include product information or platforms that allow third parties to make or leave comments.
In addition the ABPI Code requires a similar statement on materials for the general public.
Declaration of AZ involvement
It is important that the involvement of AstraZeneca with respect to certain assets and activities is declared. Such declarations must be very clear about the extent of involvement of the company, and be prominent to ensure that readers are aware of it from the start (i.e. not in a tiny footnote or at the end of a booklet).
For example, the invitation and agenda for an AZ sponsored meeting must include a prominent declaration of sponsorship.
