Annex3

WHOguidelinesonvariationstoaprequali?edproduct

Introduction96

1.Background97

1.1Objectives97

1.2Scopeandapplication98

2.Guidanceforimplementation99

2.1Reportingtypes99

2.1.1Noti?cations100

2.1.2Minorvariation(Vmin)101

2.1.3Majorvariation(Vmaj)101

2.1.4Newapplicationsandextensionapplications101

2.1.5Labellinginformation101

2.2Conditionstobeful?lled101

2.3Documentationrequired102

3.Glossary102

4.Administrativechanges104

1.Changeinthenameand/orcorporateaddressofthesupplieroftheFPP104

2.ChangeinthenameoraddressofamanufacturerofanAPIthatisnotasupplier

ofaprequali?edAPIorthatisnotsupportedbyaCEP105

3.Change