Clause 11 - Distribution of Material
11.1 Material should only be sent or distributed to those categories of persons whose need for, or interest in, the particular information can reasonably be assumed.
Clause 11.1 Distribution of Material
Material should be tailored to the audience to whom it is directed. For example, promotional material devised for general practitioners might not be appropriate for hospital doctors and, similarly, material devised for clinicians might not be appropriate for use with other relevant decision makers.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
11.2 Restraint must be exercised on the frequency of distribution and on the volume of promotional material distributed.
Clause 11.2 Frequency of Mailings
The style of mailings is relevant to their acceptability to doctors and criticism of their frequency is most likely to arise where their informational content is limited.
In the first six months following the launch of a new medicine, a health professional may be sent an initial mailing giving detailed information about its use, including, for example, the summary of product characteristics, the public assessment report, the package leaflet and the product monograph, and no more than three other mailings about the medicine.
No more than eight mailings for a particular medicine may be sent to a health professional in a year.
Mailings concerned solely with safety issues can be sent in addition to the above as can mailings about price changes which contain no product claims.
The limitations on frequency of mailings do not apply to emails as these can only be sent with the prior permission of the recipient.
- The supplementary information to Clause 9.7, Extremes of Format, Size or Cost, states that particular care needs to be taken in this regard in the first six months following the launch of a medicine to avoid criticism of the industry. Why is this limited to the first six months following launch?
- Why are there limitations on the volume of advertising (Clauses 6, 9.7, 11.1 and 11.2) and number of visits by representatives (Clause 15.4)?
- Why is there a need for particular care to be taken around extremes of format, size or cost in the first six months following the launch of a medicine?
11.3 Mailing lists must be kept up-to-date. Requests to be removed from promotional mailing lists must be complied with promptly and no name may be restored except at the addressee’s request or with their permission.