Meetings between the DRA and applicants can be helpful to both parties. They can minimize delays and correspondence, clarify misunderstandings, and avoid expensive and time-consuming legal proceedings. However, the authority must maintain control over the venue, conduct and content of the meeting.

Because the authority must maintain its impartiality, meetings should normally take place on its premises. It is useful for more than one member of staff to be present so that (1) subsequent misunderstandings can be resolved and (2) any perception of conflict of interest or bias is avoided. A staff member of the authority should normally chair the meeting. It is also useful for the authority to prepare a brief note fore the file outlining decisions taken and any departures from normal (written) policy. Future disagreements can be avoided if a copy of the file note is forwarded to the applicant company.

The party requesting the meeting should list the issues to be discussed in writing and these should be agreed in advance. The list need not be more than a few items. The authority is not obliged to agree to a meeting if it feels that the issues have already been dealt with or are adequately outlined in documentation available to the company.

The subject of such a meeting could include:

X The content of an application in a specific situation;

X Data requirements for a new type of product;

X Feedback to applicants on the reasons for failure of a particular application or applications;

X An enquiry from a new applicant that has not previously prepared a marketing authorization application;

X The discussion initiated by the DRA of inconsistencies between submitted data and information obtained by a GMP inspector.

It is prudent not to consider new data at a meeting, but to evaluate them separately. If any existing application has already been rejected, the new data may constitute a new application.