WHO can provide advice on meeting prequalification requirements and, in some cases organize specialized technical assistance if the product in question is needed urgently by countries and procurers.

Pre-submission meetings

A pre-submission meeting is an essential aspect of assessment for prequalification process, providing an opportunity for advice and guidance before submission of a dossier.

Pre-submission meetings can be especially helpful to applicants that have no or limited experience with WHO’s prequalification assessment, and are compulsory for all new applicants to WHO prequalification. However, pre-submission meetings are also useful for applicants experienced with WHO prequalification, to address issues specific to their product dossier. A pre-submission meeting can be requested by emailing diagnostics@who.int.

Technical advice

Technical advice can be sought at any time in relation to any product that is eligible for prequalification. Advice can be provided as a written response or during a meeting (e.g. in videoconference or one-to-one).

Potential applicants or applicants may forward a request for technical advice to prequalification assessors (by emailing diagnostics@who.int) or prequalification inspectors (by emailing prequalinspection@who.int) for written advice.

WHO prequalification assessors are available to meet with applicants in person either before ("pre-submission" meeting), or at any stage following submission of a dossier. Meetings can thus be organized with reference to a new or to an ongoing application. Participation of WHO prequalification inspectors in these meetings can be arranged if this is considered necessary or would be helpful.

The primary purpose of such meetings is to resolve or clarify technical issues that cannot be addressed easily by other means, such as email exchange. These issues may be general — for example, relating to WHO prequalification procedures — or specific — for example, concerning compilation of a dossier for a specific product. Applicants may request a face-to-face meeting or a meeting in the form of a teleconference or videoconference.

How to request a meeting

A face-to-face meeting, teleconference, or videoconference may be requested by email (see aforementioned email addresses). The request will be reviewed and if a meeting is considered to be worthwhile, WHO will confirm the suggested date of the meeting, or propose alternative dates, depending on the availability of any needed experts.

The applicant may be requested to provide information, to be received at least one week before the face-to-face meeting, tele- or videoconference, so that WHO staff can prepare adequately.

Applicants are requested to draft meeting minutes that summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion and action items. These must be emailed for review and comment to all those who attended, before they can be considered as final.

In accordance with WHO Staff Regulations and Rules, gifts or favours offered in connection with duties will be refused. Applicants and manufacturers are therefore requested not to offer any gifts or favours.

Specialized technical assistance

WHO provides specialized technical assistance to manufacturers of in-vitro diagnostic medical devices (IVDs) which are of interest to WHO and other UN agencies.

Specialized technical assistance related to WHO prequalification of products is managed by the WHO Local Production and Assistance Unit (LPA). LPA also supports countries and regions in strengthening and promoting local production and technology transfer to improve access to quality-assured health products.

Information on who can apply for technical assistance can be found on the following webpage.

For further information about provision of specialized technical assistance, please contact localproduction@who.int