Submission Procedure – Full Assessment of a Multisource (Generic) FPP

Documents to be submitted

Submission of an expression of interest for evaluation of a product dossier consists of two steps and involves preparation and submission of the:

  • Covering letter, in English, expressing interest in participating in WHO prequalification and confirming that the information submitted in the product dossiers is "true and correct".
  • Product dossier, in English, in the specified format for submitting product data and information. (See the section below on How to organize the product dossier.) The extent of information to be included in folder will be reduced if the application is being made using the active pharmaceutical ingredient master file (APIMF).
  • Product sample, for example a package of 100 tablets, for evaluation of product appearance, container material and labelling, and to enable chemical and pharmaceutical analysis.
  • Site master file, in English, for each manufacturing site of the medicinal product format. (A site master file is a document prepared by the manufacturer containing information with respect to the production and/or control of pharmaceutical manufacturing operations carried out at a named site, and to any closely integrated operations at adjacent and/or nearby buildings.)

How to organize the product dossier

The product dossier should be submitted in English, in both an electronic format and a paper format. It should follow the structure and format of the Common Technical Document (CTD), agreed within the framework of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (commonly known as ICH). The files it contains should be in PDF (portable document) format.

Alternatively, a dossier that has already been prepared for submission to a national drug regulatory authority, can be submitted, in PDF format, if it contains the information to the extent and level required by WHO, and is cross-referenced to the CTD format.

Additionally, a completed:

  • Quality Overall Summary: Product Dossier template
  • Quality Information Summary template
  • Presentation of Bioequivalence Trial Information form
  • Biowaiver Application form (if applicable)

should be included in the dossier. Each of these should be presented in Word format so that WHO assessors can insert questions, or requests for further data and explanation in the file, for the manufacturer's response.

Individual PDF or Word files should not exceed 10 MB in size.


Dossier submission steps

Dossier submission for a multisource (generic) product consists of two steps:

Step 1: Submission of documentation in electronic format (i.e. on CDs or DVDs) for the purpose of screening

The documents to be submitted are:

  • the covering letter
  • the product dossier
  • the site master file.

All CDs/DVDs should be numbered; the first “folder” on the CD/DVD should consist of a table of contents (cross-referenced to the CTD format if the dossier was previously prepared and submitted to a drug regulatory authority, and does not follow the CTD format).

Where to submit CDs/DVDs

The CDs/DVDs containing the covering letter, the product dossier and the site master file should be sent by mail or courier to this address in Geneva:

WHO Prequalification Team: medicines
HIS/EMP/RHT/PQT Room 628
World Health Organization

20, Avenue Appia
1211 Geneva 27
Switzerland.

NOTE ON SCREENING

Each product dossier submitted by an applicant is screened for completeness before being evaluated. A screening checklist is used when screening dossiers. This is an in-house list of dossier characteristics that need to be confirmed to be acceptable before a dossier is assigned a WHO reference number and accepted for full assessment.

The screening list provides insight into what aspects are considered to be the key elements of the assessment. It is posted on this website in order to enhance the ability of applicants to meet the screening requirements and have a greater understanding of the assessment process.

Step 2: Submission of documentation in both paper and electronic formats

Step 2 submission can be made only after the applicant has received written confirmation (by email or letter) from WHO, stating that the dossier has been accepted for assessment, and a reference number allocated to it. Once this confirmation has been received, the following should be submitted:

  • the covering letter
  • the product dossier

in both paper and electronic formats and

  • a product sample.

The paper copy of the product dossier should be organized according to the CTD structure (unless a dossier that was previously prepared and submitted to a drug regulatory authority is being submitted), bound and paginated, and should include a table of contents. Loose sheets should not be submitted for any of the information provided.

Where to submit covering letter, product dossier and a product sample

The covering letter and product dossier (both a paper copy and a copy in CD or DVD format), together with a product sample, should be sent to Copenhagen by mail or courier:

Attention: WHO Prequalification Team: medicines
Product Name: UNICEF Supply Division

Oceanvej 10− 12
2150 Nordhavn
Copenhagen
Denmark

Additional information

If additional information is requested by WHO following Step 1 submission, it should be incorporated into the product dossier before submission under Step 2.

Following Step 2 submission, additional information ― not only, to complement that already included in the product dossier, but also a site master file for each manufacturing site of the relevant active pharmaceutical ingredient(s), and a master file for the/each contract research organization, if applicable needed ― may be requested.