Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines  
 Trunk Line +632 857 1900                    Fax:  +63 2 807 0751  
 Website: www.fda.gov.ph                    Email: info@fda.gov.ph  
 
 
FDA Circular  
No. __________________  
 
 
SUBJECT:  Guidelines for the Importation and Exportation of Finished Drug 
Products  and Raw Materials   
 
 
I. RATIONALE  
 
Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Admi nistratio n 
(FDA) Act of 2009”, mandates the FDA to regulate and subsequently issue appropriate 
authorizations to establishments engaged in the manufacture, distribution, importation , 
exportation and retailing of he alth products, among others.  
 
Article I Section 6 (Requirements for Every Incoming Shipment of Health Products) of 
the Book II of the Implementing Rules and Regulation  (IRR)  of RA No. 9711, states that  
“The FDA in coordination with the Bureau of Customs, Bureau of Quarantine and other 
concerned agencies is mandated to undertake and adopt measures relating to importation 
of health products such as, but not limited to, sampling and examination, in accordance 
with relevant existing laws and regulations, of ev ery incoming shipment of health 
products” . The FDA  hereby  issued FDA Memorandum Circular (FMC) No. 2013 -032 
wherein a valid License to Operate (LTO) and Certificate of Product Registration (CPR) 
are required for  the release of drug products. However,  there  is a need to strengthen  market 
control within the distribution chain through additional measures  to ensure that the public 
only receive quality -assured drug products. The infiltration of substandard and falsified 
drug products into the supply system shall be prevented through risk -based surveillance 
scheme and rigorous control.  Therefore , as part of  the FDA’s powers and functions under 
RA No. 9711, issuance of appropriate authorization such as import/export clearance is 
necessary to strengthen  the FDA’s  overall  market surveillance  and control  regulatory 
function .  
 
In the interest of public health, import /export activities related to drug products need to be 
controlled and under the proper oversight of the FDA. Issuance of this guidelines is 
imperative  to ens ure the consistency and effecti veness of these regulatory activities.  
 
 
II. OBJECTIVES  
 
This Circular aims to a chieve the following:  
 
A. Provide detailed guidelines and clear procedure s in the  issuance of Clearance for 
Customs Release (CFCR) for finished drug products  and raw materials . 
 
B. Conduct inspection of entry /exit ports  authorized by the Bureau of Customs (BOC)  
for finished  drug products and raw materials .  
 
 
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 III. SCOPE   
 
This Circular  shall apply to all FDA -licensed drug es tablishments  
[Manufacturer /Trader /Distributor (Importer/Exporter )] involved in the manufacture, 
importation and exportation  of finished  drug products  and raw materials intended for 
distribution .  
 
This Circular shall not cover  drug products  and raw materials  used in clinical trials/product 
development/research,  drug products for personal use, donations, and under 
Compassionate Special Permit , and shall be processed based on existing rules and 
regulations.  
 
 
IV. DEFINITION OF TERMS  
 
A. Air Way Bill  (AWB ) refers to a transport document for airfreight, used by airlines 
and international freight forwarders, which specifies the holder or consignee of the bill 
who has the right to claim delivery of goods when they arrive at the port of destination. 
It is a contract of carriage that includes carrier conditions, such as limits of liability 
and claims procedures. In addition, it contains transport instructions to airlines and 
carriers, a description of the goods, and applicable transportation changes.  (CMO No. 
06-2018) 
 
B. Bill of Lading  (B/L)  refers to a transport document issued by shipping lines, carriers , 
and international freight forwarders or non -vessel operating common carriers for 
water -borne freight. It is a contract of carriage between the carrier and the shipper 
which defines the liabilit ies of each party. The holder or consignee of the bil l has the 
right to claim delivery of the goods at the port of destination.  It may refer to a Master 
Bill of Lading or a House Bill of Lading. (CMO No. 06 -2018)  
 
C. Bureau of Customs (BOC)  refers to the national agency under the Department of 
Finance in charge  of imports, exports, and foreign trade.  
 
D. Clearance for Customs Release (CFCR)  refers to a document issued by the  
 FDA certifying that the health product and establishment comply with the FDA 
regulations and thus recommending the release of the regulated imports.  
 
E. Commercial Invoice  refer s to a legal document between the supplier and the customer 
that clearly describe s the so ld goods, the amount due on the customer. (CMO No. 06 -
2018)  
 
F. Drug , drug product , pharmaceutical product , or medicinal product  refers to 
chemical compound(s) or biological substance(s), other than food, intended for use in 
the treatment, prevention, or diagnosis of disease in humans or animals, including the 
following:  
1. any article recognized in official pharmacopoeias and formularies, including 
official homeopathic pharmacopoeias, or any documentary supplement to any of 
them, which are recognized and adopted by the FDA;  
2. any articles intended for use in the diagnosis, cure, mitigation, treatment, or 
prevention of disease in man or other animals;   
 
 
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 3. any article, other than food, intended to affect the structure or any function of the 
body of human beings or animals; or  
4. any articles intended for use as a component of articles, specified in clauses (1), 
(2), or (3) not inc luding devices or their components, parts or accessories.  
5. herbal or traditional drugs as defined in R.A. No. 9502, known as the “Universal 
Accessible, Cheaper and Quality Medicines Act”  
 
G. Drug Distributor/Importer /Exporter  refers to any establishment tha t imports or 
exports raw materials, active ingredients and/or finished products for its own use or 
for wholesale distribution to other establishments or outlets.  
 
H. Drug Manufacturer  refers to any establishment engaged in operations involved in 
the production of  a drug, including propagation, processing, compounding, finishing, 
filling, packing, repacking,  altering,  ornamenting and labelling with the end in view 
of storage, distribution or sale of the  product: provided that  for the purpose of this 
regulation the compounding and filling of  prescriptions in drugstores and hospital  
pharmacies shall not be considered as production  operations.  
 
I. Drug Trader  refers to any establishment which is a registered owner of a drug product 
and the formulation and procures the raw materials and packing components, and 
provides the production monographs, q uality control standards and procedures, bu t 
subcontracts the manufacture of such product to a licensed manufacturer. In addition, 
a trader may also engage in the d istribution and/or exportation in wholesale of its own 
drug products and importation of raw materials for the production by its c ontract 
manufacturer.  
 
J. Finished Drug Product refers to a drug product that has undergone all stages of 
production and quality control, including packaging in its final container and labeling.  
 
K. Packing List  refer s to the itemized list of articles usually included in each shipping 
package, giving the quantity, description and weight of the contents. (CMO No. 06 -
2018)  
 
L. Proforma Invoice  refers to a draft invoice given by the shipper to a 
recipient/consignee prior to the shipment of goods. It provides information on the 
nature, quantity, value and weight of goods to be imported.  
 
M. Raw Material  refers to all substances whether active  or excipients that are employed 
in the processing of a finished  drug product. (AO No. 103 s. 2002)  
 
 
V. GENERAL GUIDELINES  
 
A. All manufacturers , traders  and distributors of drug products and raw materials shall 
secure a Clearance for Customs Release (CFCR) from the FDA  prior to 
importation/exportation.  
 
B. The CFCR  shall be issued to the Marketing Authorization Holder (MAH) with valid 
License to Operate  (LTO)  as manufacturer/ trader/ distributor and valid only f or the 
specific importation /exportation  of drug products with valid Certificate of Product 
Registration  (CPR)  and to manufacturers , traders  and distributors  with vali d LTO that 
imports/exports raw materials.   
 
 
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C. The applicant shall submit  documentary  requirements to support the application for 
CFCR through the FDA eServices Portal System.  The CFCR shall be valid only for a 
period of three (3) months from date of issu ance and good only for a single shipment.  
 
D. Importation /Exportation of drug products  and raw materials  shall be channeled  
exclusively through the identified Bureau of Customs (BOC) port listed in Annex A. 
The applicant shall indicate  their chosen port of entry /exit in the application.  
 
E. Facilities  of BOC ports  shall be inspected periodically by the FDA to ensure  
compliance with Good Storage Practice s (GSP)  and other relevant existing rules and 
regulations . 
  
F. All applications shall be filed a s early as one month prior to the arrival /departure of 
the shipment to/from the Philippines .  
 
G. All applications shall be pre -assessed with regard to completeness . 
 
H. All applications  shall be  evaluated and  processed by the FDA within 5 working days  
upon receipt of payment .  
 
I. The list of drug products and raw materials issued with CFCR shall be posted in the 
FDA Verification Portal System.  
 
J. The FDA shall conduct post -marketing surveillance activities  including but not limited 
to collection of drug product samples for testing, inspection of involved 
establishments/  facilities, collaboration with BOC  and Law Enforcement Agencies 
(LEAs)  and take necessary regulatory actions to violative products and establishments.   
 
 
VI. SPECIFIC GUIDELINES  
 
A. Documentary Requirements  
 
The required d etails of the LTO , CPR  and GMP Certificate issued by the FDA  shall be 
encoded,  and t he following documentary requirements  both for import and export  shall be 
uploaded to the FDA eServices Portal System:  
 
1. Drug Product  
a. Certificate of Analysis (COA)  
b. Proforma Invoice/Commercial Invoice  
c. Bill of Lading/Airway Bill  
d. Packing list  
2. Raw Materials  
a. GMP Certification for manufacturer  issued by the regulatory authority of the 
country of manufacture/origin for imported raw material  
b. Certificate of Analysis (COA)  
c. Proforma Invoice/Commercial Invoice  
d. Bill of Lading/Airway Bill  
e. Packing list  
  
 
 
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 B. Application Process  
 
Guidelines on CFCR  using eServices Portal System are provided in Annex B and 
procedure on the Use of the FDA eServices Portal System for CFCR  is available in Annex 
C of this Circular.  
 
C. Post-Approval Commitments  
 
All manufacturers , traders and distributors with approved CFCR shall be required to 
submit the following, through the eServices Portal, as post -approval commitments:  
1. Date of Arrival of the Finished Drug Products/ Raw Materials  
2. Distribution Records (Name, address of the user/buyer )  
3. Delivery Receipts and Sales invoices  
 
No succeeding request for CFCR  will be issued unless the  abovementioned  post-approval 
commitments are submitted and complied with.  
 
D. Fees  
 
The appropriate fees as specified under existing regulations shall apply, including a  Legal 
Research Fee (LRF) , following AO No. 50 s. 2001 or any amendment or latest issuance 
thereafter.  
 
 
VII. IMPLEMENTATION REVIEW  
 
Within three (3) years of its implementation, this Circular shall be reviewed and evaluated 
to determine whether the  policy's objectives, impact, and effectiveness are achieved.  
 
 
VIII.  PENALTY CLAUSE  
 
Violations of this Circular shall warrant the application of the penalties under the 
applicable provisions of RA No. 9711 and the Implementing Rules and Regulations 
thereof.  
 
 
IX. SEPARABILITY CLAUSE  
 
If any provision in this Circular, or application of such provision to any circumstances, is 
held invalid, the remainder of the provisions in this Circular shall not be affected.  
 
 
X. REPEALING CLAUSE  
 
FDA Memorandum Circular  No. 2013 -032 and a ny other circular, memorandum, 
issuance, rule and regulation which are inconsistent with the provisions of this Circular is 
hereby modified and repealed accordingly.  
 
 
  
 
 
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 XI. EFFECTIVITY DATE  
 
This Circular shall take effect fifteen (15) calendar days after publication in one (1) 
newspaper of general circulation and after submission to University of the Philippines, 
Office of the National Administrative Register (UP -ONAR).  
 
 
 
 
DR. SAMUEL A. ZACATE  
Director General  
 
Keywords  Clearance  for Customs Release , FDA eServices Portal System  
Related Issuances, laws, 
directives from other 
government agencies  Republic Act No.  9711 and its Implementing Rules and Regulations, FDA Memorandum 
Circular (FMC) No. 2013 -032, Administrative Order No. 103 s. 2002; A.O. No. 50 s. 2001; and, 
R.A. No. 11032, or the "Ease of Doing Business and Efficient Government Service Delivery 
Act".