Explain provisions of the act for loan license manufacturing and import of pharmaceuticals.
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LOAN LICENCE DEFINATION: ‘ A licence issued by a licensing authority to a applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licence’’ Condition of a loan licence under the rules :71 B ,74B, 76B.78 B.
LICENSING AUTHORITIES : LICENSING AUTHORITIES Each state government appoints licensing authorities To issues licence for manufacture,distribution and sale of drugs or cosmetics for a specified area and also having empowered to cancel or suspend the licence
Slide 4: FORM 24 A: Application for grant or renewal of a loan licence to manufacture drugs other the schedule C , C1and X drugs FORM 24E: Manufacture for sale of ayurvedic or unani drugs FORM 25 E: loan licence to manufacture for sale ayurvedic or unani drugs FORM 25A: loan licence to manufacture for sale or for distribution or drugs other than those specified n schedules C,C1 and X drugs FORM 28A: licence to manufacture for sale or for distribution of drugs specified in schedules C and C1
Slide 5: FORM27A: Application for grant or renewal of a loan licence to manufacture for distribution of drugs in schedules C&C1 FORM 32 A: loan licence to manufacture for sale or for distribution
Slide 6: PROCEDURE FOR GETTING LOAN LICENCE : Application for a grant of loan licence should be made in the prescribed forms 24A,27A with Rs-200/- or 600/- respectively The applicant has to obtain & submit a letters from the licence holder which facilities are to be availed for the manufacture. The licence authority must be satisfied that the licence holder should posses the necessary equipment ,staff capacity for manufacture &facilities for testing for a loan licence.
LICENSING AUTHORITIES : LICENSING AUTHORITIES Each state government appoints licensing authorities To issues licence for manufacture,distribution and sale of drugs or cosmetics for a specified area and also having empowered to cancel or suspend the licence
Slide 4: FORM 24 A: Application for grant or renewal of a loan licence to manufacture drugs other the schedule C , C1and X drugs FORM 24E: Manufacture for sale of ayurvedic or unani drugs FORM 25 E: loan licence to manufacture for sale ayurvedic or unani drugs FORM 25A: loan licence to manufacture for sale or for distribution or drugs other than those specified n schedules C,C1 and X drugs FORM 28A: licence to manufacture for sale or for distribution of drugs specified in schedules C and C1
Slide 5: FORM27A: Application for grant or renewal of a loan licence to manufacture for distribution of drugs in schedules C&C1 FORM 32 A: loan licence to manufacture for sale or for distribution
Slide 6: PROCEDURE FOR GETTING LOAN LICENCE : Application for a grant of loan licence should be made in the prescribed forms 24A,27A with Rs-200/- or 600/- respectively The applicant has to obtain & submit a letters from the licence holder which facilities are to be availed for the manufacture. The licence authority must be satisfied that the licence holder should posses the necessary equipment ,staff capacity for manufacture &facilities for testing for a loan licence.
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