May 15, 2012

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.


Post a Comment

Thank you for visiting. Your comments are highly appreciated.

God bless us all.



Advisory Alcohol Abuse Animal/Pets Announcement Appeal Art Ask The Pharmacist Baby backaches Beauty Beauty Tips Board Exam Board Examination Boards of Pharmacy Books Bulletin Business Career and Occupation Cars Child Care Children's Health Christmas Holiday Circular Order Classified Ads Clinics College Community Pharmacy Computer Consumer Goods Convention Cosmetics CPE 2012 Dangerous Drugs DDB Dental Care Derma Care Device Device and Apparatus Diabetes Disease Awareness DOH Donate Dreams Driving Lessons Drug Drug Abuse Drug Addiction Drug Classifications Drugs Drugstore Dual Diagnosis E-Copy EDD Edible Flowers Education Entertainment Entertainment and Lifestyle Eye Surgery FAPA 2012 Fashion FDA Academy FDA Advisory FDA Philippines FDA US Featured Article Fitness FNRI DOST Food Food and Drinks Food/Dietary Supplement Foreign Assessment FPGEE Gadgets General General Thoughts Generic Medicine Gestational diabetes Guidelines HBO therapy Healing Health Health Advice Health and Fitness Health and Safety Health Care Health Care Products Health News Health News and Update Health Tips Health Topics Healthy Living Healthy Tips Heath Heath Advice Heathy Tips Hobby Holiday Season Home Home Care Hospital Hospital Pharmacy hyperbaric oxygen therapy Industrial Pharmacy International News JOBS 2012 JOBS 2013 JOBS 2016 Laboratory Laboratory Service Ladies and Gents Laws and Regulations Legal Documents Letter from the Editor Licensed Pharmacist LTO Medical Medical Device Medicines Mens Health Music Music Therapy New Drugs New Pharmacist News and Updates Non-prescription Drug Old Age Online Course Opinion OTC Products Other Local News Patient Counseling PDEA Personal Personal Care Pharmacists Pharmacy Pharmacy Business Pharmacy Errors Pharmacy Law Pharmacy Practice Pharmacy Review Pharmacy Student Philippine Government Pimples Pinoy Pharmacists PiPharm Poll PPhA PRC PRC Philippines Pregnancy Prescription Drug Price Monitoring Charts Product Recall Product Registration Product Review Public Public Health Random Thoughts Rants References Registration Fee Registration of Pharmacist Resources Restaurant Retail Pharmacy Retailer Review Notes Safety Tips Schools of Pharmacy SEMINAR 2011 SEMINAR 2012 SEMINAR 2013 Senior Citizen Senses Services Shopping Skin Skin Care Sports Stress Student Help Student houses Substance Abuse Therapeutic Drugs Therapy Tips Training Travel Treatment Unlicensed Drugs Usapang Pinoy Videos Vitamins Website WHO Womens Health Work
Subscribe to RSS Feed Follow me on Twitter!