The document is a request for a Letter of Authorization (LOA) concerning a drug substance. It outlines specific details needed for the issuance of the LOA, such as the name, code, company, and contact information for various authorities. Additionally, it requests information on the drug's pharmacopoeial grade and any applicable references.

1. REQUEST FOR ISSUANCE OF LOA

2. Sr. No. 2Particulars Requested Details
1 Name of the Drug Substance :
2 Code of the Drug Substance :
3 Request for
Letter of Authorization / Access :
CEP LoA :
4 DMF version, if available :
5 Pharmacopoeial Grade :
6 Name of the Company :
7 Country of Registration :
8 Name & Address of Marketing Authorization
Holder (MAH)
:
9 Name & Address of MAH Contact Person (if
required in LoA)
:
10 Name & Address of Ministry of Health (MoH) :
11 Name of the MoH Contact Person (if available) :
12 Procedure / Reference Number (if any) :
13 Name of the Product / Formulation Details (to
be mentioned in the LoA)
: