Recommendation: Each individual item should have its own unique reference number (job bag number).
It is a well esablished principle under the ABPI Code, that it is the final form of an item that is approved, to which no subsequent amends may be made, and that different sizes and layouts of an item should be separately certified and have their own unique reference numbers.
Although this is not directly referenced in S.I. 541/2007, the IPHA Code nor the MfI Code as a requirement, Pharma Integrity recommends that all companies advertising prescription medicines in Ireland should also utilise unique reference numbers for different final forms of assets, as they are in effect similar but different items. Having separate identification numbers for each item additionally allows companies to be more confident in the controlled distribution and withdrawal of items.
S.I. 541/2007 requires marketing authorisation holder companies to ‘keep available a sample of all advertising emanating from his or her undertaking together with information indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination’ (24. 1(e)); by having unique reference numbers for each individual item and linking those which are related to one another (e.g. in Veeva PromoMats), each item can be easily recovered following the end of a campaign, during an audit/inspection, or in the event of a complaint being raised against a claim, an item or piece of information.nnLucy Tobin