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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.

TABLE I

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

 

TABLE II

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
Butanone
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)

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 (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)

Document Type Code Example
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.
JT Laboratory_MS_02042015_A (for application number 1)
JT Laboratory_MS_02042015_B (for application number 2)

If an application contains more than 10 chemicals, indicated a number per MSDS at the end of the file name.
JT Laboratory_MS_02042015_A_1 (for application number 1)
JT Laboratory_MS_02042015_A_2 (for application number 1)

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.


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. (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

Table I

Acetic anhydride

N-Acetylanthranilic acid

Ephedrine

Ergometrine

Ergotamine

Isosafrole

Lysergic acid

3,4-Mythylenedioxyphenyl-2-propanone

Norephedrine

Phenylacetic acid (from Table II to Table I effective Jan. 2011)

1-Phenyl-2-propanone

Piperonal

Potassium permanganate

Pseudoephedrine

Safrole

Table II

Acetone

Anthranilic acid

Ethyl ether

Hydrochloric acid

Methyl ethyl ketone

Piperidine

Sulphuric acid

Toluene

 

Ephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005)