1 
 2 
FDA Circular  3 
No. __________________   4 
 5 
 6 
SUBJECT:  Guidelines on the Importation and Exportation  Notification  for 7 
Pharmaceutical  Products  and Raw Materials   8 
 9 
 10 
I. RATIONALE  11 
 12 
Republic Act (RA) No. 3720, as amended by RA  No. 9711, otherwise known as the 13 
“Food and Drug Admi nistratio n (FDA) Act of 2009”, mandates the FDA to regulate 14 
and subsequently issue appropriate authorizations to establishments engaged in the 15 
manufacture, distribution, importation , exportation and retailing of health products, 16 
among others. Also, Section 5 of RA No. 9711 declare s the following powers of the 17 
FDA, “(b) to assume primary jurisdiction in the collection of samples of health 18 
products; (c) to analyze and inspect health products in connection with the 19 
implementation of this Act; (l) to strengthen the post -market surveillance system in 20 
monitoring health products as defined in this Act and incidents of adverse events 21 
involving such products; and (p) to maintain bonded warehouses and/or establish the 22 
same, whenever necessary or appropriate, as determined by the Director -General for 23 
confiscated goods in strategic areas of the country especially at major ports of entry .” 24 
 25 
Further, Section 23 of Executive Order No. 175 s. 1987 which amended Section 30 of 26 
RA No . 3720, states that “The Commissioner of Customs shall cause to be delivered 27 
to the Bureau samples taken at random from every incoming shipment of food, drugs, 28 
devices, and cosmetics which are being imported or offered for import into the 29 
Philippines, giving notice thereof to the owner or consignee .” In addition, Article I 30 
Section 6 (Requirements for Every Incoming Shipment of Health Products) of the 31 
Book II of the Implementing Rules and Regulation  (IRR)  of RA No. 9711, states that  32 
“The FDA in coordination with the Bureau of Customs, Bureau of Quarantine and 33 
other concerned agencies is mandated to undertake and adopt measures relating to 34 
importation of health products such as, but not limited to, sampling and examination, 35 
in accordance with relevant existing laws and regulations, of every incoming 36 
shipment of health products” . In order to effectively regulate importation activities on 37 
health products, inter -agency cooperation needs to be well -established.  38 
 39 
To implement this, FDA Memorandum Circular (FMC) No. 2013 -032, entitled 40 
“Requirements for the Immediate Release of Products Covered by the FDA at the Bureau of 41 
Customs”,  was issued, wherein only valid FDA License to Operate (LTO) and 42 
Certificate of Product Registration (CPR) were  required to be presented to the Bureau 43 
of Customs (BOC) for the release of pharmaceutical  products. However,  there is a 44 
need to strengthen  market control within the distribution chain through measures  to 45 
ensure that the public only receive s quality -assured pharmaceutical  products. The 46 
infiltration of substandard and counterfeit  pharmaceutical  products into the supply 47 
system shall be prevented through risk -based surveillance schemes  and rigorous 48 
control.  Therefore , as part of the FDA’s powers and functions under RA No. 9711, 49 
requiring the concerned pharmaceutical  establishments to notify  each 50  
 
 
Page 2 of 7 
 import ation /export ation  of pharmaceutical  products and raw materials is necessary to 51 
strengthen  the FDA’s  overall  market surveillance  and control  regulatory function .  52 
 53 
In the interest of public health, import ation and export ation  activities rela tive to 54 
pharmaceutical  products  and raw materials shall be regulated and monitored by  the 55 
FDA. Hence, i ssuance of this Circular  is imperative  in ensuring consistency and 56 
effecti veness of these regulatory activities.  57 
 58 
 59 
II. OBJECTIVES  60 
 61 
This Circular aims  to achieve the following:  62 
 63 
A. Provide detailed guidelines and clear procedure s in the  notification  process of 64 
importation and exportation of pharmaceutical  products  and raw materials . 65 
 66 
B. Establish  and identify  the authorized ports of entry and exit of pharmaceutical  67 
products and raw materials into  and out of  the country  for effective border 68 
control . 69 
 70 
 71 
III. SCOPE   72 
 73 
This Circular  shall apply to all FDA -licensed pharmaceutical  establishments  engaged  74 
in the manufacture, importation , and exportation of finished, semi -finished products 75 
or raw materials of pharmaceutical  products for human and veterinary use , except for 76 
pharmaceutical products for personal use covered under DOH -FDA -BOC Joint 77 
Circular No.  1 s. 2015.  78 
 79 
This Circular shall also  apply  to Sponsors and C ontract Research Organizations 80 
(CRO) for investigational pharmaceutical  products , and to Compassionate Special 81 
Permit (CSP) Holders  and Donee /Recipient/Consignee  for pharmaceutical products 82 
for compassionate use and donation, respectively .   83 
 84 
 85 
IV. DEFINITION OF TERMS  86 
 87 
All the terms or words used herein that are already defined under RA No. 3720 as 88 
further amended by EO No. 175 and RA No. 9711, other related FDA -implemented 89 
health laws and their respective IRRs, for the purpose of implementing this Circular, 90 
shall have the same meaning as defined therein. In addition , the following terms shall 91 
be defined as follows  for the purpose of this issuance:  92 
 93 
A. Air Way Bill  (AWB ) refers to a transport document for airfreight, used by 94 
airlines and international freight forwarders, which specifies the holder or 95 
consignee of the bill who has the right to claim delivery of goods when they arrive 96 
at the port of destination. It is a contract of carriage that includes carrier 97 
conditions, such as limits of liability and claims procedures. In addition, it 98 
contains transport instructions to airlines and carriers, a description of the goods, 99 
and applicable transportation changes.   100  
 
 
Page 3 of 7 
  101 
B. Bill of Lading  (B/L)  refers to a transport document issued by shipping lines, 102 
carriers , and international freight forwarders or non -vessel operating common 103 
carriers for water -borne freight. It is a contract of carriage between the carrier and 104 
the shipper which defines the liabilit ies of each party. The holder or consignee of 105 
the bill has the right to claim delivery of the goods at the port of destination.  It 106 
may refer to a Master Bill of Lading or a House Bill of Lading.  107 
 108 
C. Bureau of Customs (BOC)  refers to the national agency under the Department of 109 
Finance in charge of imports, exports, and foreign trade.  The mandate o f BOC is 110 
to imple ment an effective revenue collection by preventing and suppressing 111 
smuggling and the entry of prohibited imported goods. It supervises and controls 112 
the entrance of vessels and aircraft  engaged in foreign commerce. It also enforces 113 
the Tari ff and Customs Code of the Philippines and all other laws, rules and 114 
regulations related to Tariff and customs administration.  115 
 116 
D. Commercial Invoice  refer s to a legal document between the supplier and the 117 
customer that clearly describes the sold goods,  and the amount due on the 118 
customer.  119 
 120 
E. Compassionate Special Permit (CSP) Holder refers to a qualified institution or 121 
qualified licensed physician who has applied before the FDA and has been granted 122 
the CSP.  123 
 124 
F. Finished Pharmaceutical Product refers to a pharmaceutical  product that has 125 
undergone all stages of production and quality control, including packaging in its 126 
final container and labeling.  127 
 128 
G. Law Enforcement Agencies (LEAs)  refer to agencies responsible for enforcing 129 
the law, particularly the activities of prevention, detection, and investigation of 130 
crimes and the apprehension of the criminals or offenders.  131 
 132 
H. Packing List  refer s to the itemized list of articles usually included in each 133 
shipping package, giving the quantity, description and weight of the contents.  134 
 135 
I. Proforma Invoice  refers to a draft invoice given by the shipper to a 136 
recipient/consignee prior to the shipment of goods. It provides information on the 137 
nature, quantity, value and weight of goods to be imported.  138 
 139 
J. Raw Material  refers to all substances whether active or excipients that are 140 
employed in the processing of a finished  pharmaceutical product.  141 
 142 
K. Semi -finished Pharmaceutical  Product  refers to a pharmaceutical product that is 143 
obtained during the manufacturing process, and that, with further processing, can 144 
become a finished  pharmaceutical product.  145 
 146 
 147 
 148 
 149 
 150  
 
 
Page 4 of 7 
 V. GENERAL GUIDELINES  151 
 152 
A. A notification must be submitted for every shipment and all batches/lots of 153 
pharmaceutical products or raw materials covered by this guideline . The following 154 
entities/ establishments with valid FDA -LTO and CPR /authorization  of the 155 
pharmaceutical product  or raw  materials,  if applicable,  shall notify the FDA of all 156 
of their importation/exportation activities:  157 
 158 
Establishment  Pharmaceutical product  
Manufacturer, Trader  Raw material , semi -finished 
pharmaceutical product  
Distributor/Importer/Exporter  Finished pharmaceutical product , 
Investigational pharmaceutical product  
Sponsor , CRO  Investigational pharmaceutical product  
CSP Holder (Institution/Physician)  Pharmaceutical  products under CSP  
Donee /Recipient/Consignee  Donated pharmaceutical product  
 159 
B. All notifications shall be filed within one month (1 day to 30 days) prior to the 160 
arrival/departure of the shipment to/from the Philippines.  161 
 162 
C. The pharmaceutical establishment s, including the CSP Holders and  163 
donee s/recipients/consignees , shall submit documentary requirements to support 164 
the notification through the FDA eServices Portal System. The applicant s shall 165 
undertake responsibility for the submission of complete and correct application 166 
documents  to the FDA, in accordance to  the list of requirements a nd acceptable 167 
equivalent document  stipulated by the guidelines . The FDA eServices Portal 168 
System for this process shall accept notifications during the operating period of 169 
FDA Online Services.  170 
 171 
D. The pharmaceutical  establishment shall indicate the date of arrival/departure at 172 
their chosen port of entry/exit in the notification. Importation/Exportation of 173 
pharmaceutical products and raw materials shall be channeled exclusively through 174 
the established and identified Bureau of Customs (BOC) port listed in Annex A.  175 
Should there be changes in the port of entry/exit (i.e. due to port congestion), the 176 
pharmaceutical  establishment shall amend their previous notification.   177 
 178 
E. The Notification Acknowledgement shall be issued  through the official email  to 179 
the pharmaceutical establishments after the successful submission of notification 180 
through the FDA eServices Portal System . 181 
 182 
F. The list of pharmaceutical products and raw materials notified for importation and 183 
exportation shall be posted in the FDA Verification Portal System.  184 
 185 
G. Following the existing regulations, t he BOC shall process  and release the  186 
importation or expor tation shipment without  the need to present the notification 187 
acknowledgment  but upon presentation of the FDA authorizations  cited below :  188 
 189 
Authorization  Type  
Valid LTO and CPR  Pharmaceutical products  for distribution   
 
 
Page 5 of 7 
 Valid  LTO and Import License  Investigational pharmaceutical product s 
Valid CSP Pharmaceutical products for compassionate use  
Valid CPR for Donation  Pharmaceutical products for donation  
 190 
H. BOC ports  and third -party warehouses shall be inspected by the FDA to ensure  191 
compliance with Good Distribution and/or Storage Practice s (GDP/ GSP)  and 192 
other relevant existing rules and regulations . 193 
 194 
I. The FDA shall  conduct risk-based post-marketing surveillance activities  upon 195 
arrival/departure including but not limited to  collection of pharmaceutical  product 196 
samples for testing, inspection of involved establishments/  facilities, collaboration 197 
with BOC  and Law Enforcement Agencies (LEAs) , and other regulatory actions 198 
as necessar y. 199 
 200 
J. The foregoing general guidelines are nonexclusive and shall not preclude the FDA 201 
from performing other regulatory and enforcement activities, and the covered 202 
establishments to allow inspection of their regulated activities and collaborate 203 
with the FDA authorities on action taken for consumer protection, as may be 204 
authorized by law, other rules, and regulations.  205 
 206 
 207 
VI. SPECIFIC GUIDELINES  208 
 209 
A. Documentary Requirements  210 
1. The required d etails of the LTO , CPR  and local  GMP Certificate issued by the 211 
FDA  shall be encoded,  and t he following documentary requirements  both for 212 
import and export  of finished, semi -finished pharmaceutical products and raw 213 
materials  shall be uploaded to the FDA eServices Portal System:  214 
a. Certificate of Analysis (COA) , if available  215 
b. Proforma Invoice/Commercial Invoice  216 
c. Packing list , if applicable  217 
 218 
2. The required details of the LTO and Import License issued by the FDA shall be 219 
encoded, and the proforma invoice/commercial invoice shall be uploaded to the 220 
FDA eServices Portal System both for import and export of investigational  221 
pharmaceutical  product s. 222 
 223 
3. The required details of the CSP issued by the FDA shall be encoded to the FDA 224 
eServices  Portal System for importation of pharmaceutical products for 225 
compassionate use.  226 
 227 
4. The required details of the CPR issued by the FDA for importation of 228 
pharmaceutical products for donation shall be encoded to the FDA eServices 229 
Portal System.  230 
 231 
 232 
 233 
 234  
 
 
Page 6 of 7 
 B. Notification  Process  235 
 236 
1. Guidelines on notification using FDA eServices  Portal System are provided in 237 
Annex B and the procedure on the use of the FDA eServices Portal System for 238 
Notification  of finished, semi -finished pharmaceutical products and raw materials  239 
is provided in Annex C.  240 
 241 
2. Procedure on the use of the FDA eServices Portal System for Notification of 242 
investigational pharmaceutical products, and pharmaceutical products for 243 
compassionate use and donation shall be released on separate issuance s.  244 
 245 
3. In case where the cause of delay is due to force majeure or fortuitous events 246 
which result to damage or destruction of documents, and/or system  failure of the 247 
computerized processing, other official modes of notification (i.e., registered mail 248 
or personal delivery) shall be resorted to and the prescribed processing times shall 249 
be suspended and appropriate adjustments shall be made, provided the same shall 250 
be made known to the affected applicants or stakeholders.   251 
 252 
C. Post-Notification Commitments  253 
 254 
All entities/establishments with notification for importation and exportation of 255 
pharmaceutical  products , raw materials , investigational pharmaceutical  products, and 256 
pharmaceutical products under CSP and donation,  shall be required to  input and  257 
submit the following  within fifteen (15) working days from the arrival/departure of 258 
the shipment , through the  FDA  eServices Portal  System , as post -notification  259 
commitments:  260 
 261 
1. Date of Arrival /Departure  of the pharmaceutical produc ts  262 
2. Bill of Lading/Airway Bill  263 
3. Certificate of Analysis (COA), if not provided during the notification process  264 
for finished pharmaceutical products/raw materials  265 
 266 
Procedure on the Use of the FDA eServices Portal System for Post -Notification 267 
Commitment is provided in Annex D. Noncompliance with the submission of post - 268 
notification  commitments shall result in regulatory action without prior notice.  269 
 270 
D. Inspection of BOC Ports and Third -Party Warehouses  271 
 272 
1. All the identified designated BOC ports and third -party warehouses to be used for 273 
the importation and exportation of pharmaceutical  products  and raw materials  274 
shall be  inspected .  275 
 276 
2. Designated ports shall have secured storage facilities, including cold storage 277 
areas.  The FDA and BOC shall ensure that the appropriate environmental 278 
conditions are maintained for storage, and monitor that the equipment is 279 
maintained and in good working order.  280 
 281 
3. Inspections shall  be done by the FDA to ensure compliance with GDP/GS P and 282 
other relevant existing rules and regulations.  283  
 
 
Page 7 of 7 
 E. Post-Marketing Surveillance  284 
 285 
1. The FDA  in coordination with BOC , following a risk -based approach, shall  286 
collect pharmaceutical  products and raw materials  based on established 287 
procedures  and subject the sample to physical and chemical analysis. The 288 
consignment will be released from the BOC but shall be inspected in  the MAH 289 
warehouse  290 
 291 
2. All unauthorized shipments and shipments containing unauthorized 292 
pharmaceutical products  and raw materials , shall be seized by the BOC , in 293 
coordination with FDA , and hold the shipment for further investigation.   294 
 295 
3. The FDA shall ensure that the BOC has access to the FDA eServices  Portal 296 
System for verification of the importation/exportation notification.  297 
 298 
4. The FDA shall  collaborat e with the BOC and LEAs  for the relevant investigation 299 
and legal actions , when necessary.  300 
 301 
5. The FDA shall inspect involved establishments /entities  and take necessary 302 
regulatory actions against  violative products and establishments /entities .  303 
 304 
 305 
VII. REGULATORY ACTION  306 
 307 
Noncompliance with the provisions of this Circular will subject the product and 308 
establishment /entities to stricter post-marketing surveillance and appropriate 309 
regulatory actions.  310 
 311 
 312 
VIII.  SEPARABILITY CLAUSE  313 
 314 
 If any part, term, of provision of this Circular shall be declared invalid or 315 
unenforceable, the validity or enforceability of the remaining portions or provisions 316 
shall not be affected and this Circular shall be construed as if it did not contain the 317 
particular invalid or unenforceable or unconstitutional part, term, or provision.  318 
 319 
 320 
IX. EFFECTIVITY CLAUSE  321 
 322 
This Circular shall take effect fifteen (15)  days after  its publication in  a newspaper of 323 
general circulation and upon  filing of three (3) certified copies to the University of the 324 
Philippines -Office of the National Administrative Register (UP -ONAR).  325 
 326 
 327 
 328 
 329 
DR. SAMUEL A. ZACATE  
Director Genera l 
 330