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 All comments can be sent at cdrr.od@fda.gov.ph. Deadline of submission of comments shall be by 08 January  2021.

   I. BACKGROUND/RATIONALE

Rule 31, Section 1 of the Joint DOH-DTI-IPO-BFAD Administrative Order No. 2008-01 entitled the Implementing Rules and Regulations of Republic Act 9502 Otherwise known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008” stipulated that every drug product that are subject to price regulation shall reflect the retail price which shall not exceed the maximum retail price. Executive Order No. 821 s. 2009 “Prescribing the Maximum Drug Retail Prices for Selected Drugs and Medicines that Addresses Diseases the Account for the Leading Causes of Morbidity and Mortality”, 5 drug molecules or 27 drug formulas are subjected to price regulation

By virtue of E.O. No. 104 s. 2020 “Improving Access to Healthcare through the Regulation of Prices in the Retail of Drugs and Medicines” the drug product under price regulation are further expanded to 122 drug molecules or 205 drug formulas. On 12 May 2020, in consideration to the COVID-19 pandemic, a Memorandum was released by the DOH for the compliance of labeling materials for MRP medicines until 02 June 2021.

To reduce the regulatory burden in the application and approval of the inclusion or update of the MRP or the Maximum Drug Retail Price (MDRP) statement to the labeling materials of drug products, this Circular is hereby issued.

Read more:-> Draft for Comments-Application of Labelling Compliance of Drug Product under Maximum drug retail price