- July 24, 2018
- Posted by: Atty. James Biron
- Category: Legal News
The Food and Drug Administration is taking vital moves to address the backlog in processing various applications which the agency has inherited from the past.
The FDA Director-General Nela Charade Puno said she would issue a directive that would lead to the immediate decision on all applications for food and drug products that had been pending with the FDA for 6 months or more.
Puno said, “Starting September, applications for license to operate and product registration pending with the FDA for 6 months or more will be approved provided they have fully complied with the requirements and paid the fees.” She also said, “This will clear the way for the implementation of a better system for filing and processing of applications and claiming of approved permits and certificates of product of registration (CPR).”
Permits and CPRs granted under this initiative would still be subject to back-ends checks. This, she said, would be a “one-time procedure” and would be completed by the last quarter of this year. “I want to make it clear that this is not a policy, but just an intermediate step to the implementation of a more efficient system,” Puno said.
Image source: RMN.ph
Hello Atty. James! I would like to apply for an LTO for my new product.. Is there a more simplified way to get it? Or someone to do the paperworks?
Hello Darwin, I sent you a reply via email
Hi Atty. James! How I do apply for an LTO with CPR. Where do I start? Please help. Thank you and God bless you!
Hi Atty.James, I want to get license for my product. But im confused what are the requirements to export international.
Our eLTO with order of payment thru oncoll Landbank has been non existent for months now and counting, even the FDA regional level has no idea how to help us. After the previous pharmacist resigned, I take over the eApplication and its variation. The FDA email does not response to my eLTO follow up form
Hello James, Can I ask, how long it takes from submit the application until we get the LTO and CPR nowadays? do we still have to wait for 6 months? Thank you for your help.
Hi Atty. I want to ask what requirements needed for FDA LTO as Food Manufacturer. We want to manufacture powder amd in capsules food supplement like turmeric, guyabano, etc.
Hoping for your feedback.
Hello atty. james. I wold like to apply for an LTO and CRP for my new household hazardous substances product. Is there a more simplified way to get it?
And we want to know how long it will take if we have completed papers..
Thank you