How to organize the product dossier

Manufacturers should make every effort to ensure that their product dossier is clear and well-organized to help make the prequalification assessment procedure as efficient as possible. Poorly-prepared dossiers may be rejected and destroyed without full review. Some general guidance is given below. Poorly-prepared dossiers may be rejected and destroyed without full review. Some general guidance is given below.

Product dossier completeness

Manufacturers must submit all necessary sections of a product dossier. Failure to do so may result in WHO not accepting the dossier, significant delays in the assessment process, or termination of the assessment process.

Note: Manufacturers should not submit a product dossier to WHO unless requested to do so by WHO. Dossiers submitted in the absence of a request from WHO will be destroyed without review.

Content alignment

Information that was previously submitted in the application will be considered during the review of the product dossier. Therefore, manufacturers should ensure that the content of the product dossier is consistent with the information submitted in the application form and that any changes in the information submitted with the respective application form are promptly notified to WHO. Furthermore, inadequacies identified at the application form stage and communicated by WHO to the manufacturer are expected to be addressed as part of the dossier submission.

Layout and order

Submissions formatted according to the WHO requirements prescribed on this website are preferred. However, submissions previously prepared for various national regulatory authorities may be accepted if all the information required by WHO is supplied, and if the information is fully cross-referenced to the WHO prequalification of male circumcision devices requirements using the product dossier checklist (see Guidance documents section below).

The manufacturer should submit two hard-copies of the dossier and one electronic-copy (CD or DVD) of the entire dossier. The hard-copies should each include a table of contents and the first page of each hard copy should be the product dossier checklist. All sections of the dossier should be cross-referenced to this first page. The electronic copy of the dossier should be identical to the hard-copies in regard to content.

Any further amendments of the dossier must be submitted in two hard-copies and one electronic-copy.

The hard-copies should be provided in a ring-binder. If a dossier comprises multiple volumes, the volumes should be clearly marked 1 of 2, 2 of 2. etc. This also applies to product dossier amendments. The hard-copy should be clearly divided into sections, as prescribed in the product dossier checklist, and the pages of each section should be numbered

Prequalification assessment process may be terminated if the dossier does not include the required information.

Language and units of measure

The dossier will be reviewed as an English language document. All documents presented in the dossier should be submitted in English (unless other arrangements were made with WHO before submission of the dossier). Any translations of documents should be carried out by a certified translator. Details of the translator should be provided. The original and the translated document should be provided.

Metric units shall be used, except where there are other internationally accepted units of measurement.

Dossier format

One printed copy and one electronic copy (exact duplicate of the printed copy in a CD or DVD only) of the entire product dossier must be submitted. A signed document attesting that the content of the electronic version is an exact duplicate of the printed copy must also be provided. The printed product dossier should either be bound or presented in a clearly marked set of ring-binders.

The printed copy will be destroyed by WHO after completion of the dossier screening phase.

Electronic copy requirements

PDF is the primary file format used for the electronic copy. However, you must not include any PDF that requires a password to open it. The electronic copy must be organized as per the format prescribed for the printed copy. The name of the file name should be descriptive of its content and meaningful to the reviewers: it can consist of up to 125 characters and include spaces, dashes (but not elongated dashes), underscores and full stops. However, the name of the file must not contain any of the following special characters or it will fail to load.

• apostrophe (’)
• asterisk (*)
• backward slash (\)
• colon (:)
• double quotation marks ("")
• elongated dash (–)
• forward slash (/)
• greater than sign (>)
• less than sign (<)
• pound sign (£)
• question mark (?)
• single quotation mark (')
• vertical bar (|)
• tilde (~)
• various other symbols (e.g., →,*,β,α,∞,±,™)

When creating a PDF from the source document (e.g. Microsoft Word document), please consider whether or not to use Adobe® plug-ins to create PDF files and/or capture or display data; information may not display correctly if a reviewer does not have access to certain plug-ins.

All PDF files should be created directly from the source documents whenever feasible rather than creating them by scanning. PDF documents produced by scanning paper documents are far inferior in legibility to those produced directly from the source document, such as a Microsoft Word document. For any scanned document, we highly recommend that you perform optical character recognition (OCR) so that the text is searchable. Check that the content has been correctly converted by: (1) highlighting an area of text and (2) searching for a word or phrase. If the word or phrase is not returned in the search, then the OCR did not recognize the text. WHO recognizes that use of OCR may not be feasible in some cases for documents that include figures and/or images. So it may sometimes be appropriate to include scanned documents in the electronic copy.

Dossier submission

The dossier should be sent to:

WHO Prequalification Unit: male circumcision devices
MHP/RPQ/PQT Room M615
World Health Organization
20, Avenue Appia
1211 Geneva 27
Switzerland.