Biologicals- For Importers

Biologicals- For Importers

 

There are various regulatory approvals, permissions and NOC’s required for import of biologicals in India and is a tedious process. It can be simplified and eased by expert regulatory backup and support. We provide end-to end regulatory support in obtaining the necessary license, approvals and NOC’s required for import of biologicals in India.

 

Registration

Registration Certificate for biologicals means a certificate issued under Rule 27A by the licensing authority (Form 41) for registration of premises and biologicals manufactured by the manufacturer meant for import into and use in India. The Registration certificate is applied in Form 40 and granted in form 41 for biologicals.

The process of obtain Registration certificate for Biologicals requires a lot of detail documentation. CliniExperts is the pioneer in providing such services. For more information on our services contact

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Import License

Import licence means a licence, Form 10, to import biologicals excluding those specified in Schedule X, or a licence in Form 10-A to import biologicals specified in Schedule X. The applicant fills the Form 8 to obtain the Form 10 and Form 10A.

The process of obtain Import License for Biologicals requires a lot of detail documentation. CliniExperts is the pioneer in providing such services. For more information on our services contact

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Marketing Authorization (Form 44, Form 45)

The importer/sponsor have to submit application on Form 44 for permission of new drug (biologicals) approval under the provisions of Drug and Cosmetics Act 1940 and Rules 1945. Form 44 is an application for grant of permission to import or manufacture a new drug (biologicals). For importers, it is obtained in Form 45. The requirements for Chemical and Pharmaceutical information are as per the International Submission requirements of Common Technical Document (CTD) and have five modules: Administrative/Legal Information, Summaries, Quality Information (Chemical, Biological and Pharmaceutical), Non-Clinical Information and Clinical Information.

CliniExperts, the leading global regulatory expert provides end to end regulatory solutions for Biologicals. For more information contact

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Permission for Clinical Trial and Global Clinical Trial (GCT) CDSCO

Biologicals are large, complex substances produced using recombinant DNA technology. The Central Drugs Standard Control Organization (CDSCO) plays a vital role in regulating the manufacture and import of these biologicals in India. It not only ensures their safety, efficacy and quality, but also enforces the regulations on the companies that manufacture it. Permission is required from CDSCO for conducting any clinical trials in India.

We at CliniExperts are committed to get you necessary permissions for clinical trials and GCT by the CDSCO. For more information contact

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