FOOD AND DRUG BLOG

UNCATEGORIZED

What is the
di!erence
between an
LTO and a
CPR?
September 3, 2012 / " 2

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

1. LTO as Food
Importer/Distributor/Wholesaler or
Exporter
2. LTO as Drugstore is different from LTO as
Drug Distributor
3. LTO as Drug
Importer/Distributor/Wholesaler
4. LTO as Household Hazardous
Importer/Distributor
5. LTO as Cosmetics Importer/Distributor
6. 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 Certi"cate 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:

1. Food products
2. Food Supplements
3. Medicines/Pharmaceuticals/OTC
4. Medical Device
5. Veterinary products
6. 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.

By: Ria David-Cababay

CPR FDA

LTO

$ % & '

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.

Reply

#
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?

Reply

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