Important Definitions related to Import of Pharmaceutical Products

Import licence:
means either a licence in Form 10 to import drugs ;excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X

Licensing authority:
means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22 of Drug and Cosmetic Act & Rules/.

Licence for examination, test or analysis: means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis

Manufacturer: includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and /or in other major countries

Registration Certificate: means a certificate issued under Rule 27A of Drug and Cosmetic Act & Rules 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.

Form of application for import licence: An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X.

Form of application for Registration Certificate: An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40. 

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