Certificate of Product Registration

Pharmacy

Each product companies wish to work with must undergo a separate product registration process. Depending on the classification of products to be marketed (food, food supplement, drug, cosmetic, household hazardous, pesticides, medical device, diagnostics or veterinary products)  there is a vastly different registration requirement and processing time.

Triple i Consulting has a team of pharmacists on staff to consult with FDA Philippines, one of the most stringent government offices in the Philippines. Below you will find the requirements and procedures for applications.Contact Us to arrange an initial consultation.


Requirements for Product Registration with FDA

Please see our guide on Product Registration from BFAD

  • Accomplished application form No.1 and No. 8 Duly Notarized.
  • Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer.
  • Copies of valid LTO’s for manufacturer/trader/distributor/seller/exporter/importer.
  • Unit Dose and Batch Formulation in Metric System.
  • Technical specification on all Raw Materials.
  • Certificate of Analysis on raw materials and finished product from manufacturer.
  • Technical Specification on finished Product.
  • Master manufacturing procedure, Production equipment, Sampling and In-process controls, Master packaging procedure.
  • Assay on test procedures and data analysis if applicable.
  • Stability study in accordance with Philippines national guidelines and ASEAN guidelines.
  • Representative sample of packaging and labeling materials for commercial market.
  • Copy of ACB approval
  • For foreign manufactured products, a copy of the Original Product Registration in the manufacturing country.

Procedure for Product Registration with FDA

  • Submission of application and all requirements to Public Assistance Information and Compliance Section of FDA for assessment.
  • Accounting and billing department to asses registration fees to be paid at cashier.
  • Product services division of FDA will evaluate all the requirements and prepare endorsement for Certificate of Registration.
  • Director signs Certificate of Registration and Product Registration documents can be picked up from FDA.

Metro Manila Head Office

Address: 18th Floor Salcedo Tower
169 HV Dela Costa, Salcedo Village 1227 Makati City, Philippines
Tel: +63 2 513 7947
+63 2 551 9013
+63 905 3130064
Fax: +63 2 551 8052
Email: info@tripleiconsulting.com