Screening & Assessment

In order to ensure an efficient prequalification process, each submitted application will be screened to confirm that it is both administratively and technically complete.

Administrative screening

  • ensures that the submission is complete and there are no missing signatures, documents or modules;

Technical screening

  • Identifies issues/gaps within the modules which need clarification in order to support the initiation of the assessors’ review.

Three outcomes of the screening process are possible:

  1. Request for Information (RFI). If deficiencies are identified (administrative or technical) an RFI letter will be sent to the applicant.
  2. Acceptance for Assessment (AFA). If the submission is deemed complete, an AFA letter will be sent to the applicant. The AFA letter may contain clarifying questions for which a requested submission date will be provided. The AFA will contain instructions and a letter of agreement (LOA) which must be signed and returned before the application can continue in the prequalification process.
  3. Screening Failure. If the submission is deemed to be incomplete, a screening failure letter will be sent to the applicant. Applicants may resubmit their application(s) after the identified deficiencies have been addressed. A screening failure finding does not prejudice future applications.A screening failure finding does not prejudice future applications.

Next steps

Once the application is determined to be complete, and the signed LOA is received, two parallel activities will commence:

  • assessment of the application by experts as part of the Assessment Session for Vector Control Products (ASVCP) and, if needed, Joint Meeting for Pesticide Specifications (JMPS); and
  • inspection of the manufacturing facilities, to ensure compliance with WHO-recommended quality standards.

ASVCP Meetings

ASVCP meetings occur at least twice each year.

Although ASVCP meetings are integral to product assessments, neither the initiation nor conclusion of an assessment is tied to the dates of the ASVCP meetings, and applications are accepted throughout the year.

Inspection

VCP prequalification inspection consists of 2 procedures:

  1. desk review of submitted documentation;
  2. onsite inspection(s).

Onsite inspections are required for the site(s) of manufacture of the Vector Control Product (VCP), as well as, where needed, site(s) of manufacture of source materials and any relevant contract research organizations).

Onsite inspections are coordinated and conducted by the WHO Inspection Services team of experts.

For detailed information about onsite inspection please review the inspection services and the inspection services procedures website.