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Q.

What is license loan?

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0 2023-06-08T12:24:23+00:00

Hi,

A business that holds the marketing authorisation for a medicine that is legally permitted to be manufactured and marketed enters into a loan licence manufacturing agreement. This arrangement is made possible by Rule 75A and Form 28 of the 1945 Drugs and Cosmetics Rules. A loan licence arrangement transfers the trademark and product specification knowledge to a manufacturing firm so that it may use the facilities and personnel of the manufacturing company. The medication is produced under the direction of a business that holds a Loan Licence in accordance with Form 28. The owner of the Loan licence is accountable for the product's quality, effectiveness, and safety. The name of the loan licensee and the location where the product is manufactured by the licensee manufacturing firm are both clearly stated on the product label.

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