MENU

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.

Requirements

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

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

3. Company Profile (CP)

4. Material Safety Data Sheet / or Safety Data Sheet (with complete CAS Number) (MS) or Certification from Supplier/s (CS) or Certificate of Analysis (complete assay for products with 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: Application form and attached documents shall be placed in CD or USB Flash Drive. Only Applications in CD or USB with complete requirements and in correct format will be accepted.

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

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

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. File the application. An officer from the DDB Legal Division will receive, evaluate/ analyze the application/documents. If documents are complete, a transaction/reference number will be given to the applicant.
2. Application will be processed and approved.
3. Wait for the release of the approved Certification or Exemption. (The status of application may be checked online using the Application for Certification and Exemption Database System)
4. Pay the corresponding Fee of P300.00 per request (maximum of 10 items/ request) pursuant to Board Regulation No. 1, Series of 2014.

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