Dangerous drugs and controlled precursors and essential chemicals and their preparations/mixtures
- Document symbol
- G/LIC/N/3/PHL/15/Rev.1
- Original language
- English
- Published on
- 21/02/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Pursuant to Section 5, Article III of Board Regulation No. 1, Series 2014, PDEA shall impose applicable regulatory control measures or combination of measures such as:
(a) registration and/or the grant of a license; or
(b) in the case of import, transit, and export activities, registration and/or licensing, and;
(i) import, transit, and export permits issued to the operator by the PDEA for each of such activities;
(ii) a permit for each intended import or export transaction, or for each transit or redirection;
(iii) an export permit for each intended export transaction, conditional on the prior receipt of an import certificate issued by the competent authorities of the country of intended import.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
PDEA issues licenses to entities handling Dangerous Drugs & Controlled Precursors and Essential Chemicals and their preparations/mixtures engaged in import and export activities.
Q3. The system applies to goods originating in and coming from which countries?
The License issued by applies to goods originating in and coming from other countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The license is being issued to authorize entities to engage in import and export Dangerous Drugs & Controlled Precursors and Essential Chemicals and their preparations/mixtures.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
Republic Act No. 9165 or the Comprehensive Dangerous Drugs Act of 2002.
Procedures
Q6. 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):
Please see 6.1-6.11.
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? 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?
There is a published information for import and export licensing under Board Regulation No. 1, Series 2014. There is an allocation of quotas for dangerous drugs only under INCB website. A formal filing of application for import and export license is required through the PDEA Compliance Service. The allowable maximum quantity for each importer is based on the submitted Annual forecast. There is no exception or derogations from licensing requirements.
Applicants shall file application to PDEA with complete disclosure of activity the company shall engage with and compliance to documentary requirements. A Physical Security Inspection is conducted to determine qualification and capacity of applicant prior approval and issuance of appropriate license.
Q6.II. How is the size of the quotas determined: on a 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 fresh licence on a six-monthly or quarterly basis?
The allowable maximum quantity for dangerous drugs for each importer is based on the submitted Annual forecast.
Q6.III. Are licences allotted 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 the 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.)
Names of importers to whom licenses have been allocated is made known to governments and export promotion bodies of exporting countries only upon request.
Q6.IV. 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?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Issuance of licenses is classified as a Highly Technical Transaction with a lead time within 20 working days
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. 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?
Q6.VIII. 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?
Q6.IX. 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?
Q6.X. In cases where imports are allowed 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?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Applications are to be submitted at least 15 days prior to the arrival of the shipment. Pursuant to Board Regulation No. 1, Series of 2014, the Board may exempt products from some regulatory measures. However, the procedure for exemption provides the submission of an application to DDB through the Executive Director. Thus, all importations of substances falling within the Tables should have the necessary exemptions applied for and approved by the DDB.
The above Regulation provides that Finished products/ preparations and chemical mixtures containing controlled chemicals regardless of the percentage content that are intended for sale may be exempted; and finished products/ preparations and chemical mixtures containing controlled chemicals that are for company use that are within or above the threshold limits may apply for an Exemption from DDB. Prior to the issuance of an Exemption, the client/consignee is required to have a PDEA 5-IM License. On the other hand, if the product is above the threshold limit, the client has the option whether to apply for a Special Permit from PDEA (per shipment) or a Board Resolution for Exemption (valid for one year) from the Board (Subject for deliberation by DDB, PDEA, NBI, PNP).
The Applications for Certification for non-controlled chemicals and Exemptions for products/chemical mixtures containing controlled chemicals are processed online using the Online Application for Certification and Exemption Information System (OACEIS) which can be accessed through https://oaceis.ddb.gov.ph/
Q7.b. Can a licence be granted immediately on request?
License is different from 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.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may 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.
Q7.d. 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?
PDEA issues the license for the substances listed/named/identified per DDB regulation.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
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?
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?
An appeal may be presented before the Dangerous Drugs Board Appeals Committee
If so, to what bodies and under what procedures?
The applicant whose application is denied may seek reconsideration with the PDEA.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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 published list of authorized importers?
There is no published list of authorized importers.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The application forms and checklist requirements can be downloaded through:
• http://pdea.gov.ph/index.php?option=com_phocadownload&view=file&id=3:p-license&Itemid=192
• http://pdea.gov.ph/index.php?option=com_phocadownload&view=file&id=12:s-license&Itemid=192
Q11. 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.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
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 litres 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 litres or less but less than 5,000 kilograms or litres, 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 litres or more, as the case may be.
The fee for the importer license amounts to PHP 5,000.00/year
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment required.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence 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.
Q15. 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.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The imports licenses and permits are non-transferable.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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.
Other Procedural Requirements
Q18. 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.