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
- Medicines/Pharmaceuticals/OTC
- 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.
If you need assistance applying for an LTO or a CPR for your products, please don’t hesitate to contact Triple i Consulting . Our team of expert FDA Consultants will be more than happy to assist you.
2 comments
Amanda
April 29, 2013 at 1:55 pm
Shouldn’t it be getting the CPR first before the LTO coz what if the FDA rejects your application for product registration for some reason? But you already paid for the LTO. Can you claim back the expenses for obtaining the LTO?
Thank you.
admin
April 30, 2013 at 2:55 am
@Amanda the LTO is the prerequisite for the CPR since this product registration must be attached to a licensed body. You cannot ask for a refund because your product is rejected. Why would your product be rejected anyways?
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