Easily Secure Your Neutral Code for Drug Export
India has garnered a considerable reputation as the “pharmacy of the world”. Hence, pharmaceutical manufacturers are utilizing this reputation to establish a drug export business. The neutral code for drug is one of the essential requirements for exporting drugs. We at Pharmadocx Consultants are here to simplify the neutral code/special code application for easy drug export with neutral code.
This code is required when overseas buyers require the manufacturers to not reveal their details. The drug manufacturers cannot mention their name or address on the product label. Hence, the neutral code for pharmaceutical exporters is used.
What is the neutral code for drug export?
The neutral code (also known as special code) is issued to permit the manufacturing of drugs for export purposes. It is a unique alphanumeric identifier. The neutral code for drugs is granted to licensed pharmaceutical manufacturers only. This code is used to mask the manufacturer’s name and address on the product label and packaging. Hence, the neutral code enables drug manufacturers to export their drugs without disclosing their name and address on product labels. This may be a requirement of external laws. Additionally, the overseas buyer may not want to reveal the identity of the manufacturer to the target customers. Hence, the buyer may request the manufacturer to mask the manufacturer’s details on the pharmaceutical product. This may be done by replacing the details with the neutral code.
The manufacturer must file an application with the regulatory body to obtain the neutral code for drug export. Several supporting documents are required while applying for the neutral code. After the application is approved, the neutral code for drugs is granted. Then, the manufacturer can export the drugs by printing the product label with the neutral code in place of the manufacturer’s details. Therefore, drug export with neutral code helps drug manufacturers to cater to the specific labelling requirements of different importing countries.
Minimum eligibility criteria for applying for neutral code for drug export
To apply for neutral code in India, there is a certain minimum eligibility requirement:
- First and foremost, a valid drug manufacturing license is required
- Second, the manufacturer must have a product permission or a no objection certificate for the pharmaceutical product they intend to export.
Revised application process for the neutral code for drug export
CDSCO has changed the procedure for obtaining the neutral code for exporting drugs. Recently, the CDSCO has issued a notice regarding the online neutral code application process. A new online application portal has been developed to streamline and simplify the process. This digital platform will eliminate the need for paperwork and expedite the process. This step will significantly enhance the regulatory procedure for obtaining the neutral code for manufacturing pharmaceuticals with the intent of exporting them. All healthcare stakeholders have been mandatorily urged to adhere to the new online application portal and process.
Drug manufacturers seeking the neutral code have been requested to use the online submission process only via the official portal. Additionally, a checklist has also been provided on the online application portal. Thus, all applicants must refer to this checklist to apply for the neutral code for finished formulation/bulk drug.
Our team of experts will be glad to provide all the support for smooth neutral code application. Moreover, the CDSCO has modified the neutral code/special code application process. Furthermore, locating the checklist on the online portal is not easy. Hence, as drug exporters you may not be aware of the latest process for drug export with neutral code. Additionally, you need to apply on the correct online portal. Hence, we at Pharmadocx Consultants are committed to simplify your drug export with neutral code.
What are the documents required for neutral code application?
Multiple supporting documents are required for the neutral or special code application process. CDSCO has provided a detailed checklist for all the documents required for the neutral code application. Listed below is an overview of the documents necessary for the neutral code application for exporting drugs:
- Application for export no objection certificate on duly signed company’s letter head
- Valid export order on the overseas buyer’s letter head detailing the quantity and name of the drug intended for export
- A letter from the overseas buyer on their letter head mentioning the need for special code or neutral code number
- Product prototype packing material, including cartons, leaflets, labels, etc. with the neutral code
- A copy of the drug manufacturing license
- A copy of product permission for specific drug or no objection certificate for export of the specific drug
We have listed the necessary documents. Feel free to get in touch with us for document preparation support. Additionally, we will provide a detailed checklist of all the documents required for easy reference.
Why should you use Pharmadocx Consultants neutral code application service?
For exporting pharmaceuticals, special or neutral codes are sometimes required owing to external regulatory requirements or overseas buyer’s demands. The manufacturers are required to mask their name and address on the product label with these codes. The Central Drugs Standard Control Organisation (CDSCO) is the licensing authority for special or neutral codes. Thus, the application has to be sent to CDSCO. Furthermore, the CDSCO will issue the special or neutral code for drug export.
Applying for the neutral code is a time consuming and tedious process. Drug manufacturers have a lot to focus on to establish a drug manufacturing and export business. Thus, filing an application for neutral code adds to their burden of establishing a business. Moreover, any error in the application process can lead to considerable delays and the exporter may not even receive the neutral code. Neutral code for drug export application requires considerable knowledge of the regulatory guidelines and required documents. Additionally, you need to be aware of the new neutral code application process.
Here is where our neutral code application service comes into picture. We will assist you with the document preparation and filling of application. Basically, our team of experts will take care of the entire neutral code application process till you secure it. Use the form alongside to kick start your neutral code or special application. We guarantee our support will help you submit the application within the stipulated deadline and you can successfully secure the code.
Contact us to start your neutral code application process
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Why should you export drugs with neutral code?
- Different countries can have different pharmaceutical product labelling requirements. Thus, the neutral code for drug export provides a standardized label design. Without having to modify the product label per importing country’s labelling requirements, the manufacturers can easily export to different countries.
- Drug export with neutral code helps do away with the need for frequent label changes depending on the destination country. By using a standardized and uniform label design, the manufacturer can minimize labelling costs required for modifying the label per different countries’ labelling requirements.
- Manufacturers might be sceptical to disclose their identity in specific markets owing to competitive reasons or brand strategies. Using the neutral code to mask their name and address, manufacturers can safeguard their brand identity in specific markets.
Notably, by using the neutral code, drug manufacturers cannot shy away from their responsibility of manufacturing high-quality and safe drugs. Although masking of product labels with neutral code has the above benefits, the manufacturers are fully accountable for these drugs. Moreover, they will be held responsible for any adverse events associated with the drugs exported with neutral code.
Applying for neutral code for drug export
The neutral code application process is complex with various factors to consider. Additionally, you need to fulfil the eligibility criteria and prepare the required documents as per guidelines. Our neutral code application support service can make the entire process a breeze for you. Contact us using the below form to start your application for neutral code for drug export.
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