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Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA

The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing labels for drugs covered by maximum retail prices (MRPs).

In order to reduce the regulatory burden in the application and approval of the inclusion or update of the MRP statement to the labeling materials of drug products, this guideline is issued.

The objective is to provide a streamlined and rational application process for the change of labeling materials of drug products under MRP and the scope applies to all licensed drug manufacturers, traders, and distributors of drugs products under MRP.

Registered drug products under the prescribed MRP shall be given one (1) year exhaustion period of old labeling materials at the manufacturing level after the effectivity of this Circular.

Drug molecules or drug formula that will be included in succeeding EO of MRP shall likewise be given one (1) year from effectivity of the EO to transition to the provisions of this issuance and exhaust old labeling materials at the manufacturing level.

Click this LINK to know more about this guideline.


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