Dangerous Drugs Board Regulation No.1, Series 2014
- Notifying member
- Philippines
- Title
- Dangerous Drugs Board Regulation No.1, Series 2014
- First published
- 26/02/2015
- First EIF
- 13/03/2015
- Latest published
- In force to
- Latest notification
- G/LIC/N/2/PHL/197
- Product categories
- List of products subject to licensing
- Attachment
- Dangerous Drugs Board Regulation No.1-2014 - Amendments to Regulation No.3_19.06.2014.pdf 820-DDB Board Regulation No.1, Series 2014_19.06.2014.pdf
- Nature of licensing
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Non-automatic
- Administrative purpose/measure being implemented
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- Other
- Pursue obligations under the UN Charter and other international treaties (i.e. CITES, Basel Convention, Rotterdam Convention, UNSC Resolutions etc.)
- Decription of purpose/measure being implemented
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This is in compliance with the International Drug Control Conventions where the Philippines is a signatory. The Philippine Drug Enforcement Agency (PDEA), control and regulates the legitimate use of all substances internationally and locally classified as dangerous drugs and controlled precursors and essential chemicals, thus entities who wish to import, distribute, manufacture, prescribe and dispense such substances are required to secure appropriate license and permit to Philippine Drug Enforcement Agency (PDEA), Compliance Service prior to import/usage.
- Administrative body(ies) for submission of applications
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- Dangerous Drugs Board
- 3F DDB PDEA Bldg. NIA Rd., Brgy. Pinyahan, Diliman, Quezon City
- www.ddb.gov.ph
- 02-9294544 loc 151
- Contact point for information on eligibility
-
Same as the "Administrative bodies"
- Expected duration of licensing procedure
- License to import controlled substances is approved and released within the day of application upon receipt of application with complete requirements. • New application of license to import controlled substances is subject to Physical Security Inspection. After Inspection of a qualified entity, license is issued within the day of application with complete requirements. • Permit to import controlled substances is approved and released within fifteen (15) working days upon receipt of application with complete requirements and appropriate and valid PDEA License. For the Certification – depending on the number of items applied for. 1 item (1-2days); 2-5 items (2to 5 days); 10 items or more ( max of 10 days)
- Found by secretariat
- No
- Related document symbols
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- G/LIC/N/2/PHL/2
- G/LIC/N/2/PHL/4
- Notes
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Previously notified in N1PHL5-6
Comprehensive Amendments to Board Regulation No. 3 Series of 2003, “Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances”, as Amended, and Other Related Board Issuances.
Section 4(2) (d & e), Article III.
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G/LIC/N/2/PHL/2
“Comprehensive Amendments to Board Regulation No. 3 Series 2003, "Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances", as Amended, and Other Related Board Issuances.
• Mixtures/preparations/products containing controlled chemicals and reagents, analytical standards, etc. Containing dangerous drugs with specific prescribed regulatory control measures as provided under Section 4 of Board Regulation No. 1, Series 2014
All substances listed in the above regulations, are required to secure appropriate license and permit to Philippine Drug Enforcement Agency (PDEA), Compliance Service prior to import/usage.
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G/LIC/N/2/PHL/4
Comprehensive Amendments to Board Regulation No. 3 Series of 2003, “Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances”, as Amended, and Other Related Board Issuances.
Board Regulation No. 1, Series 2014 repealed Board Reg. No. 3, S. 2003. Pursuant to Section 4 of the said Regulation, chemical mixtures/finished products may be granted exemption by the Board after following the exemption criteria have been met.
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G/LIC/N/2/PHL/197
Comprehensive Amendments to Board Regulation No. 3 Series 2003, "Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances", as Amended, and Other Related Board Issuances
Modification: Eligibility of applicants, Documentation requirements (including application form), Processing time for issuing licence, Other: Payments made online.
The DDB issues Certification for Non-Controlled (without controlled chemicals) and Certification for Exemption for products with controlled chemicals.
All applications are applied prior to the arrival of shipment through the online platform OACEIS (https://oaceis.ddb.gov.ph/account/Welcome.aspx). Once the application is uploaded into the system, the evaluator will review the application together with the required documents within 1-2 working days. If approved, the system will generate a transaction/reference number and at the same time will instruct the company to pay the Php 300.00 Certification fee (per application, maximum of 10 items) through the Landbank Link.BizPortal at https://lbp-eservices.com/egps/portal/index.jsp. Further details will be provided once the client opens the Link. BizPortal.
On the other hand, if disapproved, the same will be informed of the reason(s) why the application was disapproved, and the recommendation(s), thus they may re-apply. Once the payment has been made and already posted on the system, then that’s the time the processing of the application will start. For further information, please refer to the DDB Citizen's Charter through this link: https://ddb.gov.ph/wp-content/uploads/2023/05/2023-DDB-CC_Final.pdf
Aside from the documents, if the product being imported contains controlled chemicals and is intended for use by the company (not for sale/distribution) therefore, the consignee should have the necessary Philippine Drug Enforcement Agency (PDEA) License prior to the importation and arrival of shipment.
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