Basic information
Outline of the system
Pursuant to Section 4 (2) (d & e), Article III of Board Regulation No. 1, Series 2014, the Board issues a Certificate of Exemption from specific measures of regulatory control requirements to solid, semisolid and highly viscous chemical mixtures containing Table II controlled chemicals; and when the Board is satisfied that the mixture is formulated in such a way that the controlled chemical contained in the mixture cannot be readily recovered.
Product coverage
The Board issues a Certificate of Exemption for chemical mixtures/finished products containing controlled chemicals under Table II of the 1988 UN Convention on Illicit Traffic of Narcotic Drugs and Psychotropic Substances; and Certification to non-controlled chemicals that are not included in the list of controlled substances.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non automatic licensing to pursue obligations under the UN Charter and other international treaties (i.e. CITES, Basel Convention, Rotterdam Convention, UNSC Resolutions etc.) and to protect human, animal or plant life and health.
Products under restriction as to the quantity or value of imports
The Certificate is being issued to exempt product(s) from certain regulatory control measures (ex. Exemption from the Permit and License Requirements).
Questions for products under restriction as to the quantity or value of imports
See Answers 6.1-6.11.
The system applies to products originating from which country?
The Certifications issued by the Board apply to goods originating in and coming from other countries.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
Republic Act No.9165 or the Comprehensive Dangerous Drugs Act of 2002.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Where an appropriate application has been made accordingly, PDEA may grant a license based on the following conditions:
(a) The applicant and, if a company, each director and the company secretary:
i) has never been convicted in the Philippines or elsewhere for any serious offense, or any offense however described relating to a dangerous drug or controlled chemical; and
ii) is otherwise a fit and proper person to hold a license.
(b) All places and premises at or in which the activity is to be undertaken are in fit and appropriate condition and with an appropriate signage in the place of business.
(c) The security arrangements and devices proposed at each relevant place and premises are appropriate and sufficient.
(d) The activity will, at all times, be carried out under the supervision of a person who is a fit and proper person to carry out that supervision.
(e) Where the activity relates to a controlled substance, the activity will be carried out exclusively for legitimate purposes, i.e. medical, scientific, or industrial purposes; and
(f) The outcome of physical security inspection by PDEA Regulatory Compliance Officer is satisfactory.
Is there a registration fee?
Is there a published list of authorized importers?
There is no published list of authorized importers.
Contact point for information on eligibility
Ministry/Authority
Philippine Drug Enforcement Agency
Address
PDEA Building, NIA Road, National Government Center, East Triangle, Diliman, Quezon City, NCR, Philippines
Telephone
(+632) 89208110/89279702 local 197/198
Fax
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Philippine Drug Enforcement Agency
Documentation requirements
What information is required in applications?
The application forms and checklist requirements can be downloaded through:
•http://pdea.gov.ph/index.php?option=com_phocadownload&view=file&id=3:p-l...
• http://pdea.gov.ph/index.php?option=com_phocadownload&view=file&id=12:s-...
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Applications are to be submitted at least 15 days prior to the arrival of the shipment.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There are no limitations as to the period of the year during which an application for licence and/or importation is made.
Issuing the license
Can a licence be granted immediately on request?
Certification is different from a License and/or a permit. For applicants applying for renewal of their license, as long as the requirements are complied, a temporary license shall be issued immediately after payment. With the temporary license, the client may now transact business. The official license shall be issued upon notification. For new license applicants, it may take time as it will be subjected for inspection (c/o PDEA).
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Application is applied through the online platform OACEIS. There are two circumstances: (i) If the consignee is an importer and end-user of the product containing controlled chemicals tht is below or within the threshold limit, the company needs to apply for an Exemption with DDB; and should have an updated PDEA License (P5IM). On the other hand, if the product is above the threshold limit, the company should apply for a Special Permit with PDEA or apply for a Board Resolution for Exemption with DDB. Both circumstances require a PDEA License prior to the arrival of shipment (ex. FIFO on the processing of applications,). Likewise, the consignee or the importer shall be penalized for any violation committed regarding importation of products/chemical mixtures without the appropriate license, as required. (ii) If the consignee is an importer of chemical mixtures/finished products containing controlled chemicals that are intended for sale or for distribution, therefore no license is required provided the consignee has a Certificate of Exemption issued by the Dangerous Drugs Board (DDB). OACEIS may be accessed at the DDB website https://oaceis.ddb.gov.ph/account/Welcome.aspx.
Which administrative body is responsible for approving application of licences?
PDEA issues the license for the substances listed/named/identified per DDB regulation.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
In case the quantities of controlled substances exceed 30% of the total quantity approved in relation to the approved import permit, the additional regulatory fee shall be paid. However, the request for material change in the approved permit should be made to PDEA prior to the arrival of shipment or within five days from its arrival.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
A regulatory fee shall be paid for every application for permit for import, export, or redirection of controlled substances
What is the amount of the fee or charge?
As follows:
a) PHP 500.00 when the quantity of the controlled substance or its preparations is 1,000 kilograms or liters or less, as the case may be;
b) PHP 1,000.00 when the quantity of the controlled substance or their preparations is more than 1,000 kilograms or liters or less but less than 5,000 kilograms or liters, as the case may be; and,
c) PHP 1,500.00 when the quantity of the controlled substance or its preparations is 5,000 kilograms or liters or more, as the case may be.
The fee for the importer license amounts to PHP 5000.00/year.
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment required.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Grounds for denial of registration of license – An application for a license registration may be denied by the PDEA upon a finding that the registrant/applicant:
• has materially falsified any application filed with the PDEA;
• has been indicted or convicted of a crime under any law of any country relating to any controlled substance or any other serious crimes, including cruelty to animals;
• had his PDEA license registration previously suspended or revoked;
• has pending administrative or civil or criminal case against him/her;
• has been indicted or convicted of any crime involving moral turpitude;
• had committed violations of any of the Rules and Regulation issued by the Board;
• has failed to show adequate security for the storage of a controlled substance;
• has been engaged in spurious activities; and
• the management/supervision of the business was not carried out by a fit and proper person.
Are the reasons for any refusal given to applicants?
b) Procedure for denial of registration/license:
PDEA shall within 15 working days after deliberation of the issue, render a decision to approve or not approve the application. The applicant shall be notified of the decision within five working days after the decision is made;
Have applicants a right of appeal in the event of refusal to issue a licence?
The applicant whose application is denied may seek reconsideration with the PDEA.
If so, to what bodies and under what procedures?
An appeal may be presented before the Dangerous Drugs Board Appeals Committee.
Importation
Are there any limitations as to the period of year during which importation may be made?
There are no limitations as to the period of the year during which an application for licence and/or importation is made.
What documents are required upon actual importation?
Safety Data Sheet (SDS) or Certificate of Product Registration (CPR), as applicable, and purchase order, proforma invoice or invoice.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
The importer must possess a valid import license to facilitate the issuance of the import permit.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The license has a validity of one year. The applicant has the option to apply for a three-year license validity. The validity of import permit is six months. The license or permit may not be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilization of the license or permit.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The imports licenses and permits are non-transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.
The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)
Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Yes, Board Regulation No. 1, Series 2014
Applicants shall apply in writing to the Board for issuance of Certificate of Exemption for products containing controlled chemicals that are below or within the threshold limits/and or Board Resolution for Exemption for products/chemical mixtures containing controlled chemicals. The Board may convene with the members of Technical Working Group (TWG) for Exemption Committee composed of Dangerous Drugs Board Secretariat (DDBS), Philippine Drug Enforcement Agency (PDEA), National Bureau of Investigation (NBI) and Philippine National Police (PNP) to evaluate the application for Board Resolution for Exemption. The exemption is granted if certain criteria have been met.
The company which has been granted exemption is subjected to random inspection and monitoring by the DDB Technical Working Group for Exemption.
Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?
Not applicable.
Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)
Not applicable.
From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Not applicable.
What are the minimum and maximum lengths of time for processing applications?
Releasing of Certification is within nine working days.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Not applicable.
Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Not applicable.
If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Not applicable.
In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Not applicable.
In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Not applicable.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Not applicable.