Prequalification Procedures and Fees: Male Circumcision Devices
This Prequalification Procedures and Fees section is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification of a male circumcision device (MCD).
Who can participate in WHO prequalification of MCDs?
Any legal manufacturer of an MCD can express an interest in having its MCD evaluated by WHO, provided that product is eligible for evaluation, but applications for WHO prequalification are accepted only for products that are commercially available at the time of submission for prequalification assessment.
What are the steps of MCD prequalification?
The following is a simplified overview of the prequalification process for an MCD:
- The manufacturer verifies that the MCD is eligible for evaluation.
- The manufacturer completes the application form and provides all supportive documentation as requested.
- WHO screens the application form to determine whether the product is eligible for prequalification.
- If the product is eligible for prequalification the the manufacturer will be invited to submit a product dossier.
- WHO reviews the product dossier to assess evidence in support of safety and performance of the product, and product design and manufacture, and to determine whether the manufacturer's quality management system is of an adequate standard to warrant an inspection of the manufacturing site; assess the product design and manufacture. If the dossier is not complete, the manufacturer will be requested to submit additional information within a specified time period.
- The manufacturing site inspection is carried out to assess compliance with the quality management standard ISO 13485: 2016, focusing on the suitability of the implemented processes and procedures for the reliable supply of products to WHO Member States.
- If a product meets prequalification requirements it is added to the WHO List of Prequalified Male Circumcision Devices and becomes eligible for UN procurement.
Products submitted for prequalification assessment that meet, as determined by WHO, the WHO prequalification requirements are included in the WHO List of Prequalified Male Circumcision Devices.
Timeline
WHO seeks to ensure that assessment is completed within a target timeline. Accordingly, the manufacturer will be assigned a deadline for the submission of requested information each time such a request is issued by WHO, and the manufacturer will use its best efforts to provide WHO with all requested information by such deadline.
In addition, WHO will request that inspection of manufacturing site(s) is scheduled within a defined timeframe to be communicated by WHO. The manufacturer can request an extension of the timeline for submission of the requested information or for scheduling a manufacturing site inspection.
Cancellation of an application by WHO
WHO may cancel the application for a specific product if:
- the product dossier does not contain all of the required information, including the clinical evidence, or does not meet WHO prequalification requirements, and/or
- the manufacturer is not able to, or fails to, provide the required or requested information within a specified deadline and/or
- the manufacturer is not able to, or fails to, implement any corrective actions that WHO may require within a specified deadline and/or
- the information supplied is inadequate to complete the prequalification assessment in a timely manner.
Withdrawal of an application by the manufacturer
The manufacturer may withdraw its application for prequalification assessment at any time or stage. To exercise this right of withdrawal, the manufacturer must provide WHO with written notice specifying the product(s) to be withdrawn.
If WHO cancels an application, or if the manufacturer withdraws its application, the manufacturer will not be allowed to re-apply for WHO prequalification assessment for a period of time determined by WHO, usually one year from the date of notification of cancellation, unless otherwise agreed by WHO.
Reporting and communication of assessment outcomes
The cancellation or withdrawal, at any time and for any reason, of an application for prequalification assessment of a specific product will not prejudice or otherwise affect WHO's rights to use, publish, issue, share with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (in accordance with varoious provisions, including provisions regarding the protection of any commercially-sensitive information of the manufacturer) any outcomes, reports, notices and/or results – whether in draft or final form, and whether positive or negative – arising from or relating to the prequalification assessment process, including without limitation any WHO Notices of Concern, WHO Notices of Suspension, WHO information notices for users and/or manufacturer-issued field safety notices.
What happens when an MCD is prequalified?
Once WHO is satisfied that the prequalification assessment process is complete for the relevant product, and that the product meets the WHO prequalification requirements, the product bearing a specific product name, product code(s) and regulatory version, as manufactured at the specific manufacturing site(s) inspected, will be included in the WHO List of Prequalified Male Circumcision Devices (MCDs). The list will be published on the WHO website and will specify the prequalified product name, the respective product code(s), regulatory version, the manufacturer’s name, the manufacturing site(s), the product packaging and the year in which the product was prequalified.
The manufacturer will receive a letter of prequalification from WHO informing it of the outcome of the overall prequalification assessment of the product. Once the product is included in the WHO List of Prequalified MCDs, the manufacturer will be responsible for:
- fulfilling prequalification commitments
- annual reporting
- reporting of changes
- post-market surveillance obligations
- preparing and opening the manufacturing site(s) for re-inspection
- continued compliance with WHO prequalification technical specifications.
The decision to include the product in the WHO List of Prequalified MCDs is made based upon information available to WHO at the time of the prequalification assessment, including information obtained as a result of the product dossier review, the review of the clinical evidence, the inspection of manufacturing site(s) and/or the labelling review conducted by WHO. This decision is subject to change on the basis of new information that may become available to WHO.
Information sharing with national regulatory authorities
As part of the prequalification assessment process WHO may share the manufacturer’s application and related information with interested national regulatory authorities (NRAs) – subject to WHO entering into an appropriate confidentiality undertaking with each such NRA. Furthermore, the outcome of any joint review of information by WHO and NRA(s) may be used by WHO, at its discretion, as part of the prequalification assessment process.
Duration of validity of prequalification status
The duration of the validity of the prequalification status of a product is dependent on the manufacturer's fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, including:
- prequalification commitments
- annual reporting
- reporting of changes
- post-market surveillance obligations
- preparing and opening the manufacturing site(s) for re-inspection
- ongoing compliance with WHO prequalification technical specifications, as applicable.
Post-prequalification
WHO will reassess products included in the WHO List of Prequalified MCDs and their associated manufacturing sites at intervals determined by WHO using a risk-based approach. If, as a result of this reassessment, it is found that a product and/or specified manufacturing site(s) no longer meets WHO requirements, such products will be removed from the list. Failure of a manufacturer to participate in the reassessment procedure will also lead to delisting of the product from the WHO List of Prequalified MCDs.
Prequalification fees
Prequalification fees are levied to cover part of the costs associated with product dossier screening and review, manufacturing site(s) inspection, review of labelling, dissemination of prequalification information, change assessment and dissemination of change information.
Fees must paid within a defined timeline. Failure to do so will result in cancellation of the assessment application, or change request application, or suspension of prequalification status of the prequalified product, whichever is applicable. Fees are non-refundable.
Payment of prequalification fees does not guarantee that the product will be prequalified and/or that, if prequalified, the product will retain its prequalification status for any minimum duration.
Assessment fee
A prequalification assessment fee is charged to a manufacturer once its application has been determined to be eligible for WHO prequalification assessment, as follows: US$ 5000 for dossier screening and US$ 12,000 for product assessment.
Change assessment fee
WHO will review the change documentation submitted by the manufacturer to determine the type and level of assessment required which, in turn, will determine whether the change assessment fee of US$ 3000 will be charged. The change assessment fee is waived in certain cases. WHO determines the applicability of a waiver on a case-by-case basis.
Payment of the change assessment fee does not, however, guarantee that the change will be accepted by WHO.
Annual fee
An annual fee of US$ 4000 is levied for each product listed on the WHO List of Prequalified MCDs. An invoice for the annual fee will be issued by WHO to the manufacturer on or before 1 October of each year. The annual fee is applicable to all IVDs that, by 1 September of that year, have been listed for 12 months or more. Payment of the annual fee must be made before 30 November of the calendar year in which the invoice is issued.