FDA Philippines' eLTO Application: A Tutorial

Sooo. I was tasked to apply for LTO for the pharmacy we are opening (crossing my fingers!). Let me tell you right now, it was a stressful process (still is, actually), and I blame it on FDA's super outdated web site.

I am here to be your savior, and tell you the hows of the process, and save you most of the frustration of applying for a license to operate (LTO) a drugstore (and others, too) since the information isn't readily available.

First of all, a rant. I raise my middle finger to the people who are in charge of maintaining the site. They seem to have overlooked the pages for the new process of LTO application, which has been implemented back in 2016 (it's mid-2017, now, guys, please get your act together).

Second, I'm still not done with it, so this post is still a work in progress and will be updated accordingly.

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If you go search for LTO process in FDA's site, you will be directed to http://www.fda.gov.ph/industry-corner/downloadables/237-integrated-application-form-and-process.

WARNING: Do not follow this. Do not download the form.

Here's the actual process:

You will need to request for an account to access the FDA portal.

Prepare an authorization letter, have it notarized, scan (or take a really good picture of) it and convert it to PDF file, then attach it to the email you will be sending to pair@fda.gov.ph.

EMAIL SUBJECT: Request for eLTO User Account
BODY:
a. E-mail address (preferably company e-mail address) - I took this to mean as the e-mail being name@companyname.com but if your company doesn't have that, it's fine. I used the e-mail we made for our pharmacy in Gmail.
b. Name of the authorized company representative (preferably permanently employed and not merely a consultant) - it makes sense from a security standpoint
c. Position in the company
d. Contact Number
e. Company Name

The entire thing can be found here (just click the continue reading button), with a sample authorization letter you can use as a guide.

It says that turnaround time is within two days, and requests sent after 5 pm will be processed the next day. I sent mine past 5pm, and received the user details through e-mail before 9 am the next day. Fast!

Both username and password will be provided. The password will suck balls since it's a generated string of letters and numbers; I have not yet found out how to change it, if it can even be changed.

Next, go to https://www.fda.gov.ph and log in with the provided user name and password. Do it as soon as you receive it! I think it will expire after 24 hours. I did not risk knowing if this is true or not, haha, I logged in as soon as I got the email.

To start your application, click New Case, then License to Operate, which will activate Start Case button.

Voila! You can now start your application!

I'm sorry I don't have screenshots of all the steps after, but they're pretty self explanatory. If you're lacking in info, or do not have the necessary documents, just pause your case and continue the next day (or just logout if you don't want to pause, lol).

Be prepared with these documents for a drugstore, in PDF format, not exceeding 2 MB each (to be safe, I made sure the total for all my files were less than 2 MB):

- for single proprietorship, I think you'll need a scan of DTI license; for companies, your SEC registration

- AO 34 certificate of your pharmacist (since I don't have it, I used the e-mail sent by FDA Academy telling me I'm wait-listed for the seminar; I'm hoping that they'll accept it)

- pharmacist's PRC license

Upload your requirements and you're finished. You'll need to print the Order of Payment file. If, like me, you did not print it right away, you can still get it after. Just click on Participated link on the side, double-click on your case, then click Information, choose Generated Documents. Click the box beside Order of Payment, then you can download the PDF file.

They say you can pay online via BancNet. I couldn't find out how, and my bank wasn't on the list that can be enrolled there, so I paid through Landbank.

I don't know if it's the same for all Landbank branches, but here's how mine went:

The guard outside will give you 3 or 4 copies of the payment form, which you will fill out one by one (none of those carbon copy forms huhu). The account number for FDA drugs was provided there on the tables where you fill out the forms. If in doubt, ask the guards there, haha. You will need the account code provided on the Order of Payment file, and your company name as reference.

Submit the payment form together with the Order of Payment copy and pay the amount stated there PLUS Php 40.00.

Just think, you can actually get everything done in one day, from filling out the online application to payment!

Two weeks after payment, I got an email notice that payment has been verified and that my application is now for evaluation. I checked online, and the task has been updated from Payment to LTO Evaluation.