Tuesday, May 15, 2012

Guidelines on Product Registration with FDA

A company with a valid License to Operate from FDA must register their products with FDA as well. Evaluating the safety, efficacy and quality of the product is important prior to issuance of Certificate of Product Registration (CPR). After the company secured the CPR, the product is now ready for marketing, distribution and selling.

What are the requirements for product registration with FDA? Each product has its own checklist. Please click below, the name of the product to be registered to see the checklist of requirements for registration.

In every application for registration, a duly notarized Letterof Application must be attached along with other requirements in the checklist.

Procedure for Product Registration with FDA
  1. Submit the application and all the requirements at Public Assistance Information & Compliance Section (PAICS Room 101) for assessment of documents.
  2. Accounting and billing (Room 114) for order of payment.
  3. Payment and Issuance of Official Receipt at the cashier (Room 112)
  4. Present the OR, Assessment Slip and Dossier at PAICS for issuance of Routing Slip No. (RSN)
  5. Product services Division (Ground Floor, Annex Bldg.) will evaluate the technical documents and labeling materials submitted prior to preparation of endorsement for Certificate of Product Registration (CPR) or Letter or Denial (LOD) or Notice of Deficiency (NOD).
  6. Upon endorsement for CPR, the director (Room 218) signs the CPR and will be forwarded to Releasing Section (Room 100).

Please note the schedule for application of FDA Product registration.
  • Mondays – Processed Food
  • Tuesdays and Wednesdays – Drugs, Medical Devices, Diagnostic Reagents, Drug Testing Kit, Biological and Vaccines, Herbal and Traditionally Used Medicines
  • Thursdays – Cosmetic, Household Hazardous Substances 

Product registration process from submission of requirements varies depending on type of product: for Pharmaceutical 8 months to 1 year, for Food 30- 90 days, for Cosmetics 2 weeks to 1 month and for other products, ask the officer at the PAICS.

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