Guidelines:
A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification Portal System at https://verification.fda.gov.ph and shall be updated monthly.
B. All MAHs of existing registered drug products prior to the effectivity of this Circular shall submit the facsimile/soft copy of the latest approved package insert or patient information leaflet through email at cdrr.label@fda.gov.ph with the following details:
1. Subject of email: PI/PIL for Posting [Drug Registration No.]
2. PI/PIL in readable PDF format
3. Date of Revision indicated in the PI/PIL
C. The MAH shall ensure that the format of the Summary of Product Characteristics (SPC)-like information shall be compliant with AO No. 2016-0008 and AO No. 105 s. 1991 and/or any amendment or new issuances.
D. Upon effectivity of this Circular, the FDA shall publish the PI/PIL of the newly approved drug products.
Transition Period
MAHs of all existing registered drug products upon the effectivity of this Circular shall submit the latest approved facsimile/soft copy of PI and PIL following the respective schedules provided below:
A. Monitored Release Status (Chemical/Biological) – within 2 months from the effectivity of this Circular
B. Generic Prescription drug – within the 3rd to 8th month from the effectivity of this Circular
C. Biologicals – within the 9th month from the effectivity of this Circular
D. Over-the-counter drug – within the 10th to 12th from the effectivity of this Circular
E. Traditional Medicine/Herbal Medicine/Home Remedy/Veterinary drug – within the 13th month from the effectivity of this Circular