Submission of Local Certificate of Analysis as a Requirement for Registration of Veterinary Drug and Products
BAI Letter Circular No. 03-12, issued on January 30, 2012, mandates that all veterinary drug manufacturers, traders, and distributors/importers submit a Certificate of Analysis (CA) for the registration of veterinary drugs and products. This CA must be obtained from the Bureau of Animal Industry (BAI) or recognized laboratories; if not, analyses from the manufacturer may be accepted. The CA must detail all required tests and methods, correspond to the specific batch tested, and include clear results in numerical format. Signed photocopies and computer-generated documents that meet these standards are acceptable for compliance.
Law Information
- Reference Number
- BAI Letter Circular No. 03-12
- Date Enacted
- Category
- Other Rules and Procedures
- Subcategory
- Veterinary Products
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
January 30, 2012
BAI LETTER CIRCULAR NO. 03-12
| TO | : | All Veterinary Drug Manufacturers, Traders and Distributors/Importers |
| SUBJECT | : | Submission of Local Certificate of Analysis as a Requirement for Registration of Veterinary Drugs and Products |
In order to properly comply with the requirement on the registration of Veterinary Drug and Products (VDAP) specifically on the submission of Certificate of Analysis (CA), the following must be followed:
1. Certificate of Analysis from BAI or BAI Recognized Laboratories must always be submitted.
2. Where the analysis/assay for the Veterinary Drug and Products are not being conducted by BAI or any of its recognized laboratories then the assay from the manufacturer can be accepted.
3. The Certificate of Analysis of the finished product shall include the results of all the requirements and test methods stated in the technical/quality specifications of the products.
The certificate, validated and certified shall:
a. Refer to the same batch/lot number of the samples submitted for the analyses.
b. Be on the letterhead or other paper that adequately identifies the manufacturer of the product.
c. Be dated with the date of the analyses and signed by a company officer over his/her printed name.
d. State the specifications and methods against which and by which the tests are performed.
e. Give the test result (all tests and analyses that involve measurement shall be reported as the actual numerical results, not description like "complies" or "pass")
Signed photocopies of such documents are acceptable as is a computer generated document meeting the above requirement. ADaECI
For compliance.
(SGD.) EFREN C. NUESTRO, DVM CESO IIIDirector IV
Cite This Law
Submission of Local Certificate of Analysis as a Requirement for Registration of Veterinary Drug and Products, BAI Letter Circular No. 03-12, Jan 30, 2012 (Philippines)
Submission of Local Certificate of Analysis as a Requirement for Registration of Veterinary Drug and Products, BAI Letter Circular No. 03-12 (Phil. 2012)
Related Laws
- Rules and Regulations on Registration of Veterinary Drugs and ProductsDOH Administrative Order No. 1991-0111-A • Oct 7, 1991 • Other Rules and Procedures
- Rules and Regulations on Registration of Veterinary Drugs and ProductsDA Administrative Order No. 033-91 • Oct 7, 1991 • Other Rules and Procedures
- Rules on the Regulation of Veterinary Drugs and Products, Veterinary Biological Products, and Veterinary Drug EstablishmentsDOH-DA Joint Administrative Order No. 2013-0026 • Sep 24, 2013 • Other Rules and Procedures
- Guidelines for the Issuance of a Conditional Certificate of Product Registration for Veterinary Products with Initial Registration with the BFADBFAD Bureau Circular No. 15-06 • Oct 18, 2006 • Other Rules and Procedures
- Implementing Guidelines on Brand Names of Animal Feeds and Veterinary Drug and Products for Registration with the BAIBAI Administrative Order No. 01-06 • Sep 27, 2006 • Other Rules and Procedures
- Individual Registration of Veterinary Drug and Products with Different Packaging MaterialsBAI Letter Circular No. 02-12 • Jan 4, 2012 • Other Rules and Procedures
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