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:

  1. Application form seeking Export No Objection Certificate
  2. Confirmed and Valid Export Order clearly indicating all details such as name and address of the supplier, drug, quantity 
  3. Letter of Declaration from the overseas buyer explaining the exact nature and details of the request of Special or Neutral Code number
  4. A copy of valid Manufacturing License issued by State Licensing Authority in favor of the manufacturer of the drug intended to be exported.
  5. 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.
  6. 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.

    get compliant now!

    Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner, one is already engrossed in various business aspects prior to launch of a brand in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues  as well as supply chain disruption. 

    CONTACT US FOR YOUR REGULATORY NEEDS.




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