Many times, clients ask me what the difference is between an LTO and a CPR. Please see my explanation below:
LTO or License to Operate
Is the License issued by the Food and Drug administration that allows you to be an Importer/Distributor/Wholesaler/Manufacturer of products.
Different LTO’s are issued for different classification:
LTO as Importer/Distributor/Exporter/Wholesaler issued by Regulation Division1
- LTO as Food Importer/Distributor/Wholesaler or Exporter
- LTO as Drugstore is different from LTO as Drug Distributor
- LTO as Drug Importer/Distributor/Wholesaler
- LTO as Household Hazardous Importer/Distributor
- LTO as Cosmetics Importer/Distributor
- LTO as Medical Device Importer/Distributor
For Manufacturers/Traders/Repackers LTO is issued by the Regulation Division 2.
It is important to obtain a License to Operate because it is a requirement for product registration and a requirement for the Bureau of Customs to issue a company the permit to import products.
CPR or Certificate of Product Registration
Is a certificate issued by the FDA for products that have been approved and registered in the Philippines by the bureau.
EACH product that will be registered has it’s own CPR with a designated registration number. Each product, meaning 1 CPR per variant, 1 CPR per dosage strength, 1 CPR per flavour etc.
Products with CPR are the following:
- Food products
- Food Supplements
- Medical Device
- Veterinary products
- Household Hazardous
For cosmetic products, the term is PRODUCT NOTIFICATION. This means that these cosmetics products have been notified with the FDA.