Home - Prequalification: Information for applicants
- Where and when to send the Dossier and Site Master File
|
PLEASE NOTE CHANGE OF ADDRESS OF UNICEF
SUPPLY DIVISION TO WHICH DOSSIERS SHOULD BE SENT Where to send the Product Dossier, as well as the APIMF documentation and Site Master File Product Dossier and Site Master File Please note the following steps in the submission of a product dossier to the WHO Prequalification of Medicines Programme: Step 1: The initial submission (for screening) should contain the full dossier and the filled out QOS-PD, QIS and BTIF (or BW-BCS) on CDs/DVDs (no paper copies, please) and should be sent by courier/surface mail to:
Step 2: Once the applicant has received written confirmation (e-mail/letter) from WHO stating that the dossier has been accepted for assessment and the dossier has been allocated a WHO reference number, the dossier (paper copies + CDs/DVDs) and product samples should be sent to Copenhagen as follows:
Please note (under
Step 2) that the Site Master File
(hard copies + softcopies) should be sent to Active Pharmaceutical Ingredient Master Files (APIMFs)
All
APIMF associated documentation including: APIMF open and
closed sections, quality summaries, letters of access,
responses to requests for information, or APIMF amendments
are required to be submitted in both paper and electronic
form. The
electronic copies may be provided on either CD or DVD and
should be in Word or PDF converted format.
A paper and
electronic copy (on CD or DVD)
of any APIMF submission including: APIMF open and closed
sections, letters of access, APIMF related declarations, or
responses to requests for information relating to APIMF
assessments, should be sent by courier/surface mail to:
A second
electronic copy (on CD or DVD)
of any
APIMF submission including: APIMF open and closed sections,
letters of access, APIMF related declarations, or responses
to requests for information relating to APIMF assessments,
should be sent by courier/surface mail to:
|