Authorised Agent / Registration Number Support
Understanding all the clinical regulations and complying with the standards to import drugs can be daunting. Experts at Eminence are here to help you at every stage of importing drugs, from undertaking to distributors (Form 9) to obtaining an import license (Form 10). We offer services to fill all required forms, complete documentation for an import license, pharmacovigilance, re-registration and post-registration regulatory support, all under one roof in a cost-effective manner.
Authorized Agent For
DRUG – Overview
A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India.
An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects.
Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Drug registration in India.
Who Would Need
An Authorized Agent Service?
Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.
Services Eminence Provides As An Authorized Agent
India’s pharmaceutical market is expanding at a breakneck pace, and several new regulations and amendments have been issued in the past few years. The importers of drugs need to register themselves in the country and fulfil stringent quality control requirements with meticulous documentation. The documentation of regulatory procedures is time-consuming and requires an expert’s eye.
Eminence holds a valid Drug Wholesale License in Form 20B and 21B and can act as your authorized representative in India. We, at Eminence, provide you with all the necessary assistance throughout the process of import to launch your product in time.
Owing to years of regulatory experience, Eminence authorized agents help clients with the following services:
- Registration and Re-registration
- License renewal
- PSUR
- ADR reporting
- Pharmacovigilance
- Distributor identification
- Regulatory compliance of labels as per new guidelines
- Complaint handling
- Query responses
- Product recall support
- Procure import license (Form 10)
- Notarization of documents from different Embassies in India.