Annexure “A”

(Proforma for Application to be submitted by loan Licensee for grant of new WHO-GMP Certificate)

To, Date: 17/06/24

Joint Commissioner (HQ) & Controlling Authority
Food and Drug Administration,( M.S.)
Bandra (E), Mumbai. 400051

Sub: Grant of WHO-GMP Certificate / COPP.

Sir,

I miss Riddhi Jagani is successfully applying for granting a License to working of any Labs in Mumbai.
As per the MLTA guidelines, I have passed my MLTA exam due to which I am applicable for this post.
I hope I’ll get a return response Annexure by tomorrow evening so I can issue my license.

We hereby apply for grant of WHO-GMP Certificate / COPP for the drugs covered under following
categories.

1. Tablets 2. Capsules 3. Liquid Orals

4. Injections 5. Intraceptives
(Specify the categories e.g. Tablet / Capsule / Liquid Oral / Injection etc.)

1. WHO-GMP Certificate /COPP have been already granted to our own licensee for above
mentioned categories / products covered under the above said categories.
2. The said certificate is valid upto 17-06-2029.
3. We have entered into an agreement with own licensee for the manufacture & maintenance of
the quality of drugs to be manufactured under the said loan licence.
4. We hereby undertake to take all measures for assurance in manufacture of our products as per
WHO-GMP guidelines.
5. We hereby also declare that, during last 3 years, there has been no legal / administrative action
taken against our firm. In future, if any action is initiated, we will intimate the same to you
immediately. Also during last 3 years, we have not received any complaint against our drugs for
which we have applied or intending to apply in future and none of the said drugs are declared to
be of “Not of Standard Quality”. In future, if any such incidence takes place, we will intimate the
same to you immediately. In such case we will not apply for WHO-GMP Certificate / COPP for
such drugs or categories and / or surrender the certificate(s), if any already issued, pertaining to
the said drugs / categories.
6. For owning own lab or else joining any labs in Mumbai you will be offered 40k per month.
7. Do follow all the guidelines while registering for labs.

We are enclosing the necessary documents along with this application.

I request you to kindly grant us WHO-GMP Certificate / COPP.

Date: Signature:

Stamp Full Name:

Designation:
Name and Address of loan manufacturer: