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
- Submit the application and all the requirements at Public Assistance Information & Compliance Section (PAICS Room 101) for assessment of documents.
- Accounting and billing (Room 114) for order of payment.
- Payment and Issuance of Official Receipt at the cashier (Room 112)
- Present the OR, Assessment Slip and Dossier at PAICS for issuance of Routing Slip No. (RSN)
- 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).
- 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.
No comments:
Post a Comment
I'd love to hear your thoughts. Please drop a line here and do come back as I will do all my best to reply to your comments.