Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  Fax  +63 2 807 0751  
Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 
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           FDA CIRCULAR  3 
           No. ____________  4 
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SUBJECT  : Guidelines on Labeling Requirements of Drug Products under 
Maximum Retail Price (MRP)  
 
 
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I. BACKGROUND  11 
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It is the policy of the state to protect public health and, when the public interest or 13 
circumstances of extreme urgency so require, it shall adopt appropriate measures to 14 
promote and ensure access to affordable quality drugs and medicines for all. Chapter  3, 15 
Section 26(a) of Republic Act (RA) No. 9502 entitled  “Universally Accessible Cheaper 16 
and Quality Medicines Act of 2008” stipulated that every drug product that is subject 17 
to price regulation shall reflect the retail price which shall not exceed the max imum 18 
retail price. To achieve the goal of this law to promote and ensure access to affordable 19 
quality drugs and medicines for all, Executive Order (EO) No. 821 s. 2009 “Prescribing 20 
the Maximum Drug Retail Prices for Selected Drugs and Medicines that Addres ses 21 
Diseases the Account for the Leading Causes of Morbidity and Mortality”, was issued 22 
wherein 5 drug molecules or 27 drug formulas are subjected to price regulation. The 23 
list of drug product under Maximum Retail Price (MRP) was expanded into 122 drug 24 
molecules or 205 drug formulas under EO No. 104 s. 2020. On 07 December 2021, EO 25 
No. 155 s. 2021 was issued for further improving access to healthcare through the 26 
regulation of prices in the retail of drugs and medicines and repealing EO No. 821 s. 27 
2009. The price regulation through MRP under EO No. 155 shall be imposed on the 28 
additional 34 drug molecules or 71 drug formulas.  29 
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Section VII, 6.c of Administrative Order (AO) No. 2020 -0039 “Guidelines in the 31 
Implementation of Maximum Retail Price (MRP) on Drugs a nd Medicines” states that 32 
the Food and Drug Administration (FDA) shall issue labeling requirement guidelines 33 
for MRP medicines. Relative to this, AO No. 2016 -0008 “Revised Rules and 34 
Regulations Governing the Generic Labeling Requirements of Drug Products f or 35 
Human Use” stipulated the minimum mandatory requirements that shall be required to 36 
appear on the label of products under MRP.  37 
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To reduce the regulatory burden in the application and approval of the inclusion or 39 
update of the MRP statement to the label ing materials of drug products, this Circular is 40 
hereby issued.  41 
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II. OBJECTIVES  46 
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To provide a streamlined and rational application process for the change of labeling 48 
materials of drug products under MRP.  49 
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III. SCOPE  51 
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This shall apply to all licensed drug manufacturers, traders, and distributors of drugs  53 
products under MRP.  54 
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IV. GUIDELINES  57 
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A. The following MRP statement shall be printed on the primary and secondary 59 
packaging label of the drug product on a red strip (red background or red font) 60 
following Section VI.B.7 of AO No. 2016 -0008:  61 
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UNDER DRUG PRICE REGULATION  
RETAIL PRICE NOT TO EXCEED [PRICE]  
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                                                                        OR  64 
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UNDER DRUG PRICE REGULATION  
RETAIL PRICE NOT TO EXCEED [PRICE]  
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      OR 68 
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UNDER DRUG PRICE REGULATION  
RETAIL PRICE NOT TO EXCEED [PRICE]  
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Example:  72 
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 88 SECONDARY PACKAGING  
 
ATORVASTATIN  
Brand Name  
10 mg Film -Coated 
 Batch No.:  
Expiry Date:  
Reg No.: 
UNDER DRUG PRICE 
REGULATION RETAIL PRICE 
NOT TO EXCEED PhP 34.35  Page 3 of 4 
 
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For primary label such as blister pack/foil strip, MRP statement shall be printed 109 
on every standard blister pack/foil strip. This shall exclude drug products in small 110 
containers.  111 
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B. Existing registered drug products shall follow FDA Circular No. 2016 -017 113 
“Additional Post -Approval Changes for Pharmaceutical Products”. The following 114 
documentary requirements shall be submitted for applications of Minor 115 
Variation -Notification [MiV -PH-N1] for the change or inclusion of the price or 116 
MRP  statement : 117 
1. Notarized Application Form – Notification for Minor Variation/s of Registered 118 
Pharmaceutical Product  119 
2. Integrated Application Form (IAF) in excel format  120 
3. Portable Document Format (PDF) copy of the signed IAF  121 
4. Electronic copy of the complete documentary requirements and pertinent 122 
evidences supporting the changes (c urrently approved and proposed labeling 123 
materials)  124 
5. Declaration, signed by the Head of the Regulatory Office, that there is no other 125 
changes except for the proposed variation ; and  126 
6.  Proof of payment  127 
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C. Drug products for registration (New Drug under Monitored Release, Initial, and 129 
Drug Product for Emergency Use) shall bear the MRP statement in the labels 130 
upon submission of the application.  131 
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V. TRANSITION PERIOD  134 
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Registered drug products under the prescribed MRP shall be given one (1) year 136 
exhaustion period of old labeling materials at the manufacturing level after the 137 
effectivity of this Circular.  138 PRIMARY PACKAGING  
 
UNDER DRUG PRICE REGULATION RETAIL PRICE 
NOT TO EXCEED PhP 34.35  
 
UNDER DRUG PRICE REGULATION RETAIL PRICE 
NOT TO EXCEED PhP 34.35  
 Page 4 of 4 
 
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Drug molecules or drug formula that will be included in succeedin g EO of MRP  shall 140 
likewise be given one (1) year from effectivity of the EO to transition to the provisions 141 
of this issuance and exhaust old labeling materials at the manufacturing level.  142 
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VI. PENALTY  145 
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Violations of this Circular shall warrant the application of the penalties under the 147 
applicable provisions of RA No. 9711 and RA 9502 and the Implementing Rules and 148 
Regulations thereof.  149 
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VII. SEPARABILITY CLAUSE  152 
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If any provision in this Circular or application of such provision to any circumstances 154 
is held invalid, the remainder of the provisions in this Circular shall not be affected.  155 
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VIII.  EFFECTIVITY  158 
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This Circular shall take effect fifteen (15) calendar days after publication in one (1) 160 
newspaper of general circulation and upon filing with the University of the 161 
Philippines, Office of the National Administrative Register (ONAR).  162 
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  FRANCISCO T. DUQUE III, MD, MSc  
                     Secretary of Health  
 
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