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)
1988 United Nation Convention Against illicit Traffic
In Narcotic Drugs and Psychotropic Substance.
|1||Acetic anhydride||CAS NUMBER: 108-24-7|
|2||N-Acetylanthranilic acid||CAS NUMBER: 89-52-1|
|3||Ephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005)||CAS NUMBER: 299-42-3|
|4||Ergometrine||CAS NUMBER: 60-79-7|
|5||Ergotamine||CAS NUMBER: 113-15-5|
|6||Isosafrole||CAS NUMBER: 120-58-1|
|7||Lysergic acid||CAS NUMBER: 82-58-6|
|8||3,4-Mythylenedioxyphenyl-2-propanone||CAS NUMBER: 4676-39-5|
|9||Norephedrine||CAS NUMBER: 14838-15-4|
|10||Phenylacetic acid (from Table II to Table I effective Jan. 2011)||CAS NUMBER: 103-82-2|
|11||1-Phenyl-2-propanone||CAS NUMBER: 103-79-7|
|12||Piperonal||CAS NUMBER: 103-79-7|
|13||Potassium permanganate||CAS NUMBER: 7722-64-7|
|14||Pseudoephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005)||CAS NUMBER: 90-82-4|
|15||Safrole||CAS NUMBER: 94-59-7|
|16||Acetone||CAS NUMBER: 67-64-1|
|17||Anthranilic acid||CAS NUMBER: 118-92-3|
|18||Ethyl ether||CAS NUMBER: 60-29-17|
|19||Hydrochloric acid||CAS NUMBER: 7647-01-0|
|20||Methyl ethyl ketone
|CAS NUMBER: 78-93-3|
|21||Phenylacetic Acid||CAS NUMBER: 103-82-2|
|22||Piperidine||CAS NUMBER: 110-89-4|
|23||Sulphuric acid||CAS NUMBER: 7664-93-9|
|24||Toluene||CAS NUMBER: 108-88-3|
The salts of the substance listed in Tables I & II whenever the existence of such as salts is possible (with the exception of Hydrochloric acid and Sulfuric acid) are also controlled.
|25||Thionyl Chloride (Included in CPECS list, Per DDB Reg. No. 4s. 2005)||CAS NUMBER: 7719-09-7|
REQUIREMENTS for CERTIFICATION (Non-controlled chemicals) and EXEMPTION (with controlled chemicals)
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 (for applicant of Exemption ONLY; no percentage (%) content of controlled chemicals) (CA)
5. Updated PDEA License as required (PL)
6. Formulation of the product (FP) (for manufacturers /compounders ONLY)
7. Picture of the product(s) (PP) if possible
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)
|1. Application Form||AF||JT Laboratory_AF_02042015|
|2. Sworn Statement||SS||JT Laboratory_SS_02042015|
|3. Company Profile||CP||JT Laboratory_CP_02042015|
|4a. MSDS||MS||JT Laboratory_MS_02042015
If more than one application, place letter A in the end of the file name.
If an application contains more than 10 chemicals, indicated a number per MSDS at the end of the file name.
Note: All MSDS should be converted to pdf format from MS office document
|4b. Certificate from Supplier||CS||JT Laboratory_CS_02042015|
|4c. Certificate of Analysis||CA||JT Laboratory_CA_02042015|
|5. PDEA License||PL||JT Laboratory_PL_02042015|
|6. Formulation of product||FP||JT Laboratory_FP_02042015 (for manufacturers /compounders only)|
|7. Picture of product||PP||JT Laboratory_PP_02042015|
Only Applications with complete requirements and in correct format will be accepted. Upon acceptance of application, a corresponding claim stub is issued.
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. (maximum of ten (10) working days for regular application)
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
Phenylacetic acid (from Table II to Table I effective Jan. 2011)
Methyl ethyl ketone
Ephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005)