Annexure “B”

(Proforma of letter to be submitted by own licensee, along with the application for grant of new
WHO-GMP Certificate / COPP to loan licensee)

Date:
To,

Joint Commissioner (HQ) & Controlling Authority

Food and Drug Administration, (M.S.)
Bandra (E), Mumbai. 400051

Sub: Grant of unit WHO-GMP Certificate / COPP to loan manufacturer.

Sir,

We M/s. (Name and Address of own manufacturer)

are manufacturing the drugs under the loan licence for

M/s. (Name and Address of loan licensee)

The loan licensee have applied for grant of WHO-GMP Certificate / COPP for the drugs covered
under following categories.

1. 2. 3. 4. 5.
(Specify the categories e.g. Tablet / Capsule / Liquid Oral / Injection etc.)

1. WHO-GMP Certificate /COPP have been already granted to us for above mentioned
categories / products covered under the above said categories.
2. The said certificate is valid upto__________________.
3. We have entered into an agreement with loan 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 the loan licensee 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 intimate loan licensee 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.

We are enclosing the necessary documents along with this application.

We request you to kindly grant the WHO-GMP Certificate / COPP to the Loan Licensee.

Date: Signature:

Stamp Full Name:

Designation:
Name and Address of Own manufacturer: