The approval of registration certificate and import license of drugs are issued for specific time periods and are required to be renewed under the Drugs and Cosmetic Act 1940 & Rules 1945 as amended.
In context to Re-Registration, there is no term such as Re-Registration in the Drugs and Cosmetic Act 1940 and Rules 1945 there under. Therefore an applicant has to submit the Re-Registration application (for obtaining the Form 41) in which the Drug Master file (DMF) and Site Master File (SMF) are not required to be submitted again as they have been submitted with the parent application. The application for Re-Registration Certificate is made nine months before the expiry of the existing certificate. The current Registration Certificate shall be deemed to continue in force until orders are passed on the application.
An application for re-registration shall be made to the Licensing Authority (CDSCO) in Form 40, either by the manufacturer himself, having a valid Wholesale License for sale or distribution of drugs or by his authorized agent in India having a valid wholesale License for sale or distribution of drugs. In case the re-registration/renewal of registration application is filed after the expiry of Registration Certificate, a fresh registration application needs to be filed.
The procedure for filing the application for import license, Registration and Re-Registration certificate has been made online w.e.f. 15th February 2016. All the data submitted shall remain the same.