Many times, clients ask me what the difference is between LTO and CPR. These two terms are commonly used in regulatory compliance, but they serve different purposes.
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LTO (License to Operate): This is a mandatory permit issued by the appropriate government agency, allowing a business to legally operate within a specific industry. It ensures that the company complies with relevant laws, safety standards, and operational guidelines.
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CPR (Certificate of Product Registration): Unlike an LTO, which covers the entire business, a CPR is specific to individual products. It certifies that a particular product meets regulatory standards and is approved for sale in the market.
In short, an LTO is for business operations, while a CPR is for product approval. Understanding the distinction between LTO and CPR helps businesses remain compliant and avoid potential legal issues.
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.
