Key Topic 6: 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) Here is a list of items which may be obligatory for certain materials – click on each for more information:
- Prescribing information
- Unique identifying number for each asset
- Date of preparation and expiry
- Adverse event reporting
- Declaration of AZ involvement
Prescribing Information (PI)
The elements that must be included in the prescribing information vary from country to country.
However, in general all promotional material should include PI.
(There are a few exceptions – again see your local regulations for detail on this).
Your nominated signatory will want to check that the PI is the correct version, up to date and easy to read. Check your local regulations for details on these aspects.
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 promotional material.
In addition for global materials an expiry date is required (usually 12 months after the date of preparation).
Adverse event reporting
All promotional 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.
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.
