DRUG REGISTRATION SERVICES
SPECIAL CODE/NEUTRAL CODE FOR NOC
Many times, in cases of export of pharmaceutical products , special codes are required on the product label due to external regulatory requirements.
Such approvals are approvals of Special Code or Neutral Code. CDSCO, is the licensing authority for applicants seeking permissions of Special or Neutral Code.
When a manufacturer does not intend to reflect its own name or address on the product label, an application seeking permission for Special Code or Neutral Code is submitted to CDSCO.
Approvals for Special Code and Netral Code are issued by CDSCO to Manufacturers for Bulk export of Finished Formulation.
Checklist of Documents
A specific list of information and documents required for application seeking grant of use of Special Code for Export of Finished Formulation or Bulk Drug is as follows:
- Application form seeking Export No Objection Certificate
- Confirmed and Valid Export Order clearly indicating all details such as name and address of the supplier, drug, quantity
- Letter of Declaration from the overseas buyer explaining the exact nature and details of the request of Special or Neutral Code number
- A copy of valid Manufacturing License issued by State Licensing Authority in favor of the manufacturer of the drug intended to be exported.
- A copy of Product Permission for specific product or No Objection Certificate for export issued by CDSCO for specific product Prototype Packing material including Labels, Cartons, leaflets, Blister foil etc. mentioning the specific code.
- In the case of the export of banned drugs valid registration certificate from the Ministry of Health of the importing country is to be provided
Why NKG for Drug Regulatory Services
NKG experts assist our clients in obtaining NOC for special codes on label for products such as finished formulations, Bulk drug, Narcotic drug, Psychotropic substances, etc.
in numbers from
regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
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trade commiSsions
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
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we help you meet your compliance needs
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.