Country-Specific Variation Applications (Philippines)

MaV-PH01 (Country-Specific Major Variation)

Additional route of administration

MaV-PH02 (Country-Specific Major Variation)

Change of manufacturing site of the drug product (same subsidiary)

MiV-PH01 (Country-Specific Minor Variation-Prior Approval)

Change of capsule color

MiV-PH02 (Country-Specific Minor Variation-Prior Approval)

Change of brand name

MiV-PH03 (Country-Specific Minor Variation-Prior Approval)

Change of MAH (Marketing Authorization Holder)

MiV-PH04 (Country-Specific Minor Variation-Prior Approval)

Reclassification (Rx to OTC)

MiV-PH05 (Country-Specific Minor Variation-Prior Approval)

Reclassification (OTC to HR)

MiV-PH06 (Country-Specific Minor Variation-Prior Approval)

Other variations that don’t fall under the AVG or the country-specific requirements (Others not covered by the AVG)

Letter of Request (Annex A)

Application requirement for Major/Minor Variations requiring prior approval indicating the type/s of request/s and affected product (one product per DTN)

Annex B (Notification for Minor Variation)

Application requirement for Minor Variations-Notification where the application is processed on a per product basis

Annex C

Required documents for submission when following Country-Specific Requirements