GOVPH

Companies and industries may apply for a Certification of Non-Controlled Products for substances not included in the list of dangerous drugs and Controlled Precursors and Essential Chemicals (CPECs) or Certificate of Exemption/Board Resolution for Exemption for products/ preparations/ chemical mixtures containing dangerous drugs and/or CPECs that are automatically exempted and/or above the Table of Concentration Limits. (see Table below)

Updated Lists /Scheduled Controlled Substances
as of 29 December 2017

CONTROLLED PRECURSORS AND ESSENTIAL CHEMICALS – include those listed in Table I and Table II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances as at 18 October 2017

1988 United Nation Convention Against illicit Traffic
In Narcotic Drugs and Psychotropic Substance.

TABLE I

TABLE II

The salts of the substance listed in Tables I & II whenever the existence of such as salts is possible. (The salts of Hydrochloric acid and Sulfuric acid are specifically excluded)

1961 UNITED NATIONS SINGLE CONVENTION ON NARCOTIC DRUGS AS AMENDED BY THE 1972 PROTOCOL (56th edition, July 2017)

List of Drugs Included in Schedule 1

• AND the isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation;
• the esters and ethers, unless appearing in another Schedule, of the drugs in this Schedule whenever the existence of such esters or ethers is possible;
• the salts of the drugs listed in this Schedule, including the salts of esters, ethers and isomers as provided above whenever the existence of such salts is possible

Dextromethorphan and dextrorphan are not under international control.

Narcotic Drugs Included in Schedule II of the 1961 Convention

• AND the isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation;
• the salts of the drugs listed in this Schedule, including the salts of the isomers as provided above whenever the existence of such salts is possible

For more information on the Updated Lists of Controlled Substances, click here.

REQUIREMENTS for CERTIFICATION (Non-controlled chemicals) and EXEMPTION (with controlled chemicals)

1. Application Form (AF) (Exemption / Certification)

2. Duly notarized Sworn Statement (SS) (Exemption / Certification)

3. Company Profile (CP) (FOR NEW APPLICANT ONLY)

4. Material Safety Data Sheet / or Safety Data Sheet (with complete CAS Number) (MS) or Certification from Supplier/s (for incomplete CAS) (CS) or Certificate of Analysis (complete assay for products with Controlled Chemicals) (CA)

5. Updated PDEA License as required (PL) (FOR EXEMPTION ONLY)

6. Formulation of the product (FP) (for manufacturers /compounders ONLY)

Note: Request for Certification and/or Exemption must be placed in CD or USB Flash Drive together with the complete requirements and in correct format/design (PDF WORD). A maximum of ten (10) items per request is allowed.

Example format: Company name_Document Type (Code)_date of Application (mmddyyyy)

Ex: JT Laboratory_MS_02042015_A (for application number 1)
JT Laboratory_MS_02042015_B (for application number 2)

If an application contains 10 products, indicate a number per MSDS at the end of the file name.

Ex: JT Laboratory_MS_02042015_A_1 (for product number 1 in the application)
JT Laboratory_MS_02042015_A_2 (for product number 2 in the application)

Only Applications with complete requirements and in correct format will be accepted. Upon acceptance of application, a corresponding claim stub is issued.

Procedure

1. Present the CD or USB containing the complete documents in correct format to the DDB Legal officer for evaluation. If approve, a CLAIM STUB WILL BE AUTOMATICALLY ISSUED containing the Transaction Number of the application or request upon approval of the Pharmacist-in-Charge.
2. Application will then be processed. Processing time depends upon the number of items applied for.
3. Wait for the release of the approved Certification or Exemption. The status of the application may now be checked on-line using the Application for Certification and Exemption Database System (ACEDS).
4. Pay the corresponding Fee of P300.00 per request

"NO CLAIM STUB NO CERTIFICATION POLICY"

Substances in Table I and Table II of the 1988 Convention