Some companies believe that there is a three month grace period in which to update prescribing information to reflect changes to the summary of product characteristics (SPC) and that during that period the provision of the updated SPC with promotional material bearing outdated prescribing information will regularise the position. Neither of these propositions is true.
The general principle is that the prescribing information (defined in Clause 4.2) must be up-to-date, must comply with Clauses 4.1 and 4.2 of the Code and must not be inconsistent with the particulars given in the SPC.
Some changes to an SPC however may not necessarily have to be reflected in the prescribing information. For example, the prescribing information must include at least one authorized indication consistent with the SPC. If a new indication is not being promoted in a particular piece of promotional material then it need not be mentioned in the prescribing information in that material. Similarly, information about dosage and method of use and about side effects, precautions and contra-indications has to be relevant to the indications being promoted and thus SPC changes relating to other indications do not need to be included in the prescribing information.
Apart from such special circumstances, prescribing information must be updated so that it does not become inconsistent with the SPC. For example a new indication must be included in the prescribing information in an item of promotional material promoting that indication. If a representative is promoting the new indication he or she must not leave promotional material which does not include it in its prescribing information.
When a company chooses to rely on the SPC as part of the prescribing information, the SPC so provided must be the current one.