Individual Registration of Veterinary Drug and Products with Different Packaging Materials
BAI Letter Circular No. 02-12 outlines the registration requirements for Veterinary Drugs and Products (VDAP) that utilize different packaging materials in the Philippines. Each distinct packaging must be registered separately, with detailed information provided about the materials used, including their construction, chemical properties, and any relevant standards compliance. Manufacturers must also submit stability study reports to justify the claimed shelf-life of products when changes in packaging occur, addressing potential alterations in the product's properties during storage. Compliance with these guidelines is mandatory for all veterinary drug manufacturers, traders, and distributors/importers.
Quick Answers
- What is Individual Registration of Veterinary Drug and Products with Different Packaging Materials about?
- BAI Letter Circular No. 02-12 outlines the registration requirements for Veterinary Drugs and Products (VDAP) that utilize different packaging materials in the Philippines. Each distinct packaging must be registered separately, with detailed information provided about the materials used, including their construction, chemical properties, and any relevant standards compliance. Manufacturers must also submit stability study reports to justify the claimed shelf-life of products when changes in packaging occur, addressing potential alterations in the product's properties during storage. Compliance with these guidelines is mandatory for all veterinary drug manufacturers, traders, and distributors/importers.
- What type of law is BAI Letter Circular No. 02-12?
- Individual Registration of Veterinary Drug and Products with Different Packaging Materials (BAI Letter Circular No. 02-12) is a Philippine Other Rules and Procedures enacted by the Congress of the Philippines.
- When was Individual Registration of Veterinary Drug and Products with Different Packaging Materials enacted?
- Individual Registration of Veterinary Drug and Products with Different Packaging Materials (BAI Letter Circular No. 02-12) was enacted on Jan 4, 2012.
- What is the citation for Individual Registration of Veterinary Drug and Products with Different Packaging Materials?
- Individual Registration of Veterinary Drug and Products with Different Packaging Materials, BAI Letter Circular No. 02-12, Jan 4, 2012 (Philippines)
Law Information
- Reference Number
- BAI Letter Circular No. 02-12
- Date Enacted
- Category
- Other Rules and Procedures
- Subcategory
- Veterinary Products
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
January 4, 2012
BAI LETTER CIRCULAR NO. 02-12
| TO | : | All Veterinary Drug Manufacturer, Trader and Distributor/Importer |
| SUBJECT | : | Individual Registration of Veterinary Drug and Products with Different Packaging Materials |
For purposes of clarification on the registration of Veterinary Drug and Products (VDAP) using different packaging materials, the following guidelines are hereby provided for the information and guidance of all concerned:
1. Products using packaging of different materials should have separate registration.
2. The packaging materials should give information on the construction of the container, with a list of the different components, the type of materials used in the different parts, and the nature of the polymers. If the official standards/pharmacopeia include requirements concerning the type of material used, it must be documented that these requirements will be complied with.
For plastics, the name of the material, name of the manufacturer, chemical structure, and physico-chemical properties shall be presented. For polymers intended for containers of liquid and semi-liquid drug preparation, appropriate detailed information must be provided. Complete composition, including possible polymerization residues, stabilizers, plasticizers, colouring agents etc., shall be stated. The maximum permitted content shall be indicated. A report on toxicity may be required. Technical properties of the material relevant to the proposed use shall be stated (sterilizability, permeability, transparency, resistance etc.) TIcAaH
Detailed information is required about the technical construction of non-standardized containers, e.g., aerosol containers, spray packs, etc.)
3. A new report of stability studies to justify claimed shelf-life must be provided for changes or additional packaging material employed.
Conceivable changes in the chemical, pharmaceutical or biological properties of the product during storage must be described. Changes in concentration of the preservative(s) antioxidant(s) and changes due to interaction with the container must also be considered.
Reports must specify the initial values, storage conditions, type of container and batch number. Based on this, the manufacturer shall propose a shelf life and if necessary any storage directions applicable.
For compliance.
(SGD.) EFREN C. NUESTRO, DVM CESO IIIDirector IV
Cite This Law
Individual Registration of Veterinary Drug and Products with Different Packaging Materials, BAI Letter Circular No. 02-12, Jan 4, 2012 (Philippines)
Individual Registration of Veterinary Drug and Products with Different Packaging Materials, BAI Letter Circular No. 02-12 (Phil. 2012)
Related Laws
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- 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
- 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
- Submission of Local Certificate of Analysis as a Requirement for Registration of Veterinary Drug and ProductsBAI Letter Circular No. 03-12 • Jan 30, 2012 • Other Rules and Procedures
- Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human UseDOH Administrative Order No. 2016-0008 • Mar 21, 2016 • Other Rules and Procedures
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