The product information is a key document in the regulatory process. It is the means by which the DRA agrees with the company the approved circumstances of use, including indications, patient populations, contraindications, warnings, etc., based on available information on safety and efficacy. It determines how the company may promote the product (see Annex 8), and in large measure it dictates how the product will be used in clinical practice. It is the means of communication between the pharmaceutical company and the health professions, especially the prescriber, and should be a publicly available document. Marketing authorization holders should be encouraged to make product information available on request to enquirers, including patients and health practitioners. It is desirable for DRAs to publish approved product information if resources permit.
Because of its critical role, the product information and its status should be defined in law. For flexibility, the law can lay down a requirement for a document that meets guidelines issued by the DRA. The guidelines can then be updated as the need arises.
The minimum product information provided should be that listed in the sample product information sheet (see Appendix to Annex 8). A copy of the agreed product information should accompany the certificate of marketing authorization when it is despatched by the DRA.
It is not normally acceptable to have two equivalent multisource products on the same market with product information that does not match. In general, one or both sets of the product information will have to be amended so that they are not inconsistent and are as close as possible to each other, although the wording need not be identical. Differences in product information may have to be tolerated in certain situations, particularly where local legislation allows new uses to be patented (new indications in the case of pharmaceuticals) or where market exclusivity arrangements apply. Further comment on the review of product information may be found in Annex 7.
Variations to product information which only add new safety restrictions should be permitted without prior approval but must be notified to the DRA. The model marketing authorization letter set out in Annex 9 incorporates this provision.
The advice of the expert advisory body is useful in finalizing product information, particularly to take advantage of expertise relating to local circumstances and endemic diseases.