WHO Technical Report Series, No. 981 - World Health Organization

Annex 3
Table continued
Description of change
2 Change in the name or
address of a manufacturer of
an API that is not a supplier
of a prequalified API or that is
not supported by a CEP.
Conditions to
be fulfilled
Documentation
required
Reporting
type
1 1–2 IN
Conditions to be fulfilled
1. No change in the location of the manufacturing site and in the manufacturing
operations.
Documentation required
1. A formal document from a relevant official body (e.g. NMRA) in which the new name
and/or address is mentioned.
2. An updated Letter of Access in case of change in the name of the holder of the APIMF.
Description of change
Conditions to
be fulfilled
Documentation
required
Reporting
type
3 Change in the name and/or
address of a manufacturer of
the FPP.
1 1 IN
Conditions to be fulfilled
1. No change in the location of the manufacturing site and in the manufacturing
operations.
Documentation required
1. Copy of the modified manufacturing authorization or a formal document from a
relevant official body (e.g. NMRA) in which the new name and/or address is mentioned.
Description of change
Conditions to
be fulfilled
Documentation
required
Reporting
type
4 Deletion of a manufacturing site or manufacturer involving:
4a
4b
4c
production of the API starting
material
production or testing of the
API intermediate or API
production, packaging or
testing of the intermediate
or FPP
1 1 AN
1–2 1 IN
1–2 1 IN
continues
105