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Issuance of Certification for Non-controlled chemicals and Certificate of Exemption / Board Resolution for Exemption for products /chemical mixtures containing Controlled Chemicals – This pertains to review and evaluation of requests for a Certification stating the absence of non – controlled chemicals or a Certificate of Exemption for finished products containing controlled chemicals pursuant to Board Regulation No. 1, S. 2014. All applications shall be made PRIOR to importation and arrival of shipment.

Application for CERTIFICATION (non-controlled) and EXEMPTION (with controlled chemicals)

Note: All applications shall be made PRIOR to importation and arrival of shipment. Application Form and supporting documents shall be placed in CD or USB Flash Drive.  Applications in CD or USB with complete requirements and in correct format will be accepted (Pdf Word).

REQUIREMENTS:

  1. Duly notarized Application Form (AF) (Certification and Exemption)
  2. Company Profile (CP) (FOR NEW APPLICANT ONLY))
  3. Material Safety Data Sheet / or Safety Data Sheet (with complete CAS Number) (MS) and/ or Certification from Supplier/s (for incomplete CAS) (CS) or Certificate of Analysis (complete assay for products with Controlled Chemicals) (CA)
  4. Updated PDEA License as required (PL) (FOR EXEMPTION ONLY)
  5. Formulation of the product (FP) (for manufacturers /compounders ONLY)

 

Upon acceptance of application, a corresponding claim stub is issued.

Sample Format:

Company name_Document Type (Code)_date of Application (mmddyyyy)

Ex. DDB_AF_07182016

If more that (1) one application, designate a letter or a number at the end of each file name. Each set of application must contain the complete requirements from (1-4). A maximum of ten (10) products per request is allowed.

Ex: DDB_AF_07182016_A (for application number 1) or DDB_AF_07182016_1

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

Ex: DDB_MS_07182018_A_1 (for product number 1 in application A)


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"

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

List of Controlled Chemicals
Table I Table II
Name of Precursors CAS number Name of Controlled Chemicals  CAS number
1. Acetic anhydride 108-24-7 1. Acetone 67-64-1
2. N-Acetylanthranilic acid 89-52-1 2. Anthranilic acid 118-92-3
3. Ephedrine 299-42-3 3. Ethyl ether  60-29-17
4. Ergometrine 60-79-7 4. Hydrochloric acid 7647-01-0
5. Ergotamine 113-15-5 5. Methyl ethyl ketone butanone 78-93-3
6. Isosafrole 120-58-1 6. Phenylacetic acid 103-82-2
7. Lysergic acid 82-58-6 7. Piperidine 110-89-4
8. 3,4-Methylenedioxyphenyl-2-propanone  4676-39-5 8. Sulphuric acid 7664-93-9
9. Norephedrine 14838-15-4 9. Toluene 108-88-3
10. 4-Anilino-N-phenethylpiperidine (ANPP) 21409-26-7    
11. N-Phenethyl-4-piperidone (NPP) 39742-60-4    
12. Phenylacetic acid 103-82-2    
13. alpha-Phenylacetoacetonitrile (APAAN) 4468-48-8    
14. 1-Phenyl-2-propanone 103-79-7    
15. Piperonal 120-57-0    
16. Potassium permanganate 7722-64-7 Thionyl Chloride 7719-09-7
17. Pseudoephedrine 90-82-4    
18. Safrole 94-59-7    

 

 

 

 

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