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Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
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3 FDA CIRCULAR
4 No. ____________
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SUBJECT : Guidelines on Labeling Requirements of Drug Products under
Maximum Retail Price (MRP)
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11 I. BACKGROUND
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13 It is the policy of the state to protect public health and, when the public interest or
14 circumstances of extreme urgency so require, it shall adopt appropriate measures to
15 promote and ensure access to affordable quality drugs and medicines for all. Chapter 3,
16 Section 26(a) of Republic Act (RA) No. 9502 entitled “Universally Accessible Cheaper
17 and Quality Medicines Act of 2008” stipulated that every drug product that is subject
18 to price regulation shall reflect the retail price which shall not exceed the maximum
19 retail price. To achieve the goal of this law to promote and ensure access to affordable
20 quality drugs and medicines for all, Executive Order (EO) No. 821 s. 2009 “Prescribing
21 the Maximum Drug Retail Prices for Selected Drugs and Medicines that Addresses
22 Diseases the Account for the Leading Causes of Morbidity and Mortality”, was issued
23 wherein 5 drug molecules or 27 drug formulas are subjected to price regulation. The
24 list of drug product under Maximum Retail Price (MRP) was expanded into 122 drug
25 molecules or 205 drug formulas under EO No. 104 s. 2020. On 07 December 2021, EO
26 No. 155 s. 2021 was issued for further improving access to healthcare through the
27 regulation of prices in the retail of drugs and medicines and repealing EO No. 821 s.
28 2009. The price regulation through MRP under EO No. 155 shall be imposed on the
29 additional 34 drug molecules or 71 drug formulas.
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31 Section VII, 6.c of Administrative Order (AO) No. 2020-0039 “Guidelines in the
32 Implementation of Maximum Retail Price (MRP) on Drugs and Medicines” states that
33 the Food and Drug Administration (FDA) shall issue labeling requirement guidelines
34 for MRP medicines. Relative to this, AO No. 2016-0008 “Revised Rules and
35 Regulations Governing the Generic Labeling Requirements of Drug Products for
36 Human Use” stipulated the minimum mandatory requirements that shall be required to
37 appear on the label of products under MRP.
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39 To reduce the regulatory burden in the application and approval of the inclusion or
40 update of the MRP statement to the labeling materials of drug products, this Circular is
41 hereby issued.
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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
46 II. OBJECTIVES
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48 To provide a streamlined and rational application process for the change of labeling
49 materials of drug products under MRP.
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51 III. SCOPE
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53 This shall apply to all licensed drug manufacturers, traders, and distributors of drugs
54 products under MRP.
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57 IV. GUIDELINES
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59 A. The following MRP statement shall be printed on the primary and secondary
60 packaging label of the drug product on a red strip (red background or red font)
61 following Section VI.B.7 of AO No. 2016-0008:
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UNDER DRUG PRICE REGULATION
RETAIL PRICE NOT TO EXCEED [PRICE]
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64 OR
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UNDER DRUG PRICE REGULATION
RETAIL PRICE NOT TO EXCEED [PRICE]
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68 OR
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UNDER DRUG PRICE REGULATION
RETAIL PRICE NOT TO EXCEED [PRICE]
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72 Example:
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74 SECONDARY PACKAGING
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81 Reg No.:
82 ATORVASTATIN
83 Brand Name
84 10 mg Film-Coated Batch No.:
85 Expiry Date:
UNDER DRUG PRICE
REGULATION RETAIL PRICE
86 NOT TO EXCEED PhP 34.35
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90 PRIMARY PACKAGING
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105 UNDER DRUG PRICE REGULATION RETAIL PRICE UNDER DRUG PRICE REGULATION RETAIL PRICE
NOT TO EXCEED PhP 34.35 NOT TO EXCEED PhP 34.35
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109 For primary label such as blister pack/foil strip, MRP statement shall be printed
110 on every standard blister pack/foil strip. This shall exclude drug products in small
111 containers.
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113 B. Existing registered drug products shall follow FDA Circular No. 2016-017
114 “Additional Post-Approval Changes for Pharmaceutical Products”. The following
115 documentary requirements shall be submitted for applications of Minor
116 Variation-Notification [MiV-PH-N1] for the change or inclusion of the price or
117 MRP statement:
118 1. Notarized Application Form – Notification for Minor Variation/s of Registered
119 Pharmaceutical Product
120 2. Integrated Application Form (IAF) in excel format
121 3. Portable Document Format (PDF) copy of the signed IAF
122 4. Electronic copy of the complete documentary requirements and pertinent
123 evidences supporting the changes (currently approved and proposed labeling
124 materials)
125 5. Declaration, signed by the Head of the Regulatory Office, that there is no other
126 changes except for the proposed variation; and
127 6. Proof of payment
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129 C. Drug products for registration (New Drug under Monitored Release, Initial, and
130 Drug Product for Emergency Use) shall bear the MRP statement in the labels
131 upon submission of the application.
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134 V. TRANSITION PERIOD
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136 Registered drug products under the prescribed MRP shall be given one (1) year
137 exhaustion period of old labeling materials at the manufacturing level after the
138 effectivity of this Circular.
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140 Drug molecules or drug formula that will be included in succeeding EO of MRP shall
141 likewise be given one (1) year from effectivity of the EO to transition to the provisions
142 of this issuance and exhaust old labeling materials at the manufacturing level.
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145 VI. PENALTY
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147 Violations of this Circular shall warrant the application of the penalties under the
148 applicable provisions of RA No. 9711 and RA 9502 and the Implementing Rules and
149 Regulations thereof.
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152 VII. SEPARABILITY CLAUSE
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154 If any provision in this Circular or application of such provision to any circumstances
155 is held invalid, the remainder of the provisions in this Circular shall not be affected.
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158 VIII. EFFECTIVITY
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160 This Circular shall take effect fifteen (15) calendar days after publication in one (1)
161 newspaper of general circulation and upon filing with the University of the
162 Philippines, Office of the National Administrative Register (ONAR).
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165
FRANCISCO T. DUQUE III, MD, MSc
Secretary of Health
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