Registration Certificate

Registration Certificate

 

“Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.

The Registration certificate is granted in form 41 for Drugs

Any substance falling within the definition of drug (Section 3b of the Drugs and Cosmetic Act, 1940 and Rules 1945 as amended) is required to be registered for import into the country. Not only drug but the manufacturing site needs to be registered for import. The licensing authority under rule 24-A Registration Certificate in the Form and manner specified in Rule 24-A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate.

An applicant is required to file application in Form 40 for Drugs along with prescribed fees in the form of treasury challan and all relevant data for seeking permission to import drug substances and its formulations for marketing in the country.

A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

 

 

Reference

  1. The Drugs and Cosmetics ACT, 1940 and Rules 1945. Available at- http://www.mohfw.nic-.in/-WriteReadData/l892s/43503435431421382269.pdf. Accessed on – 30th March 2016.

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