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Section VII, 6.c of Administrative Order (AO) No. 2020-0039 entitled “Guidelines in the Implementation of Maximum Retail Price (MRP) on Drugs and Medicines” states that the Food and Drug Administration (FDA) shall issue labeling requirement guidelines for MRP medicines.
This Circular shall provide guidelines to all Marketing Authorization Holders (MAHs) of drug products on the publishing of the package insert and patient information leaflet of registered drug products.
Auxiliary labels containing special pharmacists" instructions for the patient shall be required as prescribed for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions and such other drugs as may be required by law.
This document outlines revisions to the rules and regulations governing generic labeling requirements for drug products in the Philippines. It discusses the background and need for harmonization with ASEAN standards.
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:
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-005, which provides some information on the process on labelling drug products under Maximum Retail Price (MRP), in June 2022.
The Generics Act (Republic Act No. 6675) regulated labeling requirements for drugs. The BPS implements a product certification mark scheme to verify conformity of products to PNS and other international standards.