E-Library - Information At Your Fingertips: Printer Friendly 24 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 2. Valid License to Operate of manufacturer/trader/distributor/importer /exporter/wholesaler 3. Certificate of Brand Name Clearance 4. Agreement between Importer/Exporter Manufacturer and Trader or Distributor 5. General Information product's proprietary or brand name, official chemical name(s) and generic name(s) of active ingredient(s), molecular or chemical formula and structure, amount of active ingredient per unit dose, pharmaceutical form of the drug, indication, recommended dosage, frequency of administration, route and mode of administration, contraindication, warnings and precautions 6. Unit dose and batch formulation Must be in full compliance with the latest official monograph (United States Pharmacopeia, British Pharmacopeia, Japanese Pharmacopeia, European Pharmacopeia, International Pharmacopeia); name and edition of the reference may be cited in lieu of submitting a detailed list of limits and tests; when an alternative procedure or limit is used, it shall be equal to or more stringent than the official requirement For non-official or unofficial substances, separate list of technical specifications of each ingredient must include the ff: Name of substance detailed information on physical and chemical properties ID tests Purity tests Assay 7. Technical/Quality Specifications Packaging Materials of all Raw Materials including 8. Certificate of Analysis of Active Ingredient(s) 9. Technical Specifications of the Finished Product a) The appearance of the product (colour, shape dimensions, 4/21/2020, 9:19 AM