loan license

Query:  

What is loan license   

Response:

Loan Licence: Loan Licence is a process in which one pharma marketing/manufacturing company hires another pharma company manufacturing unit to process its own brands. Its like to rent or use other’s manufacturing unit or machinery to manufacture own brand.

A loan licence means a licence which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 28

Applications for the grant or renewal of loan licences for the manufacture for sale or for distribution of drugs specified in Schedules to the licensing authority

The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing to undertake the manufacture on behalf of the applicant for a loan licence

List of Documents:

Same as in case of manufacturing unit license refer. Few are discussing below

• Introductory Covering Letter mentioning Name and address of plant and administration office
• Application at prescribed Form and format
• Prescribed Fee Receipt
• Details of constitution of firm, partnership or Company
• Manufacturing License Copy of Manufacturing Unit
• Identification Proof of all Authorized persons, proprietor, partners and/or directors
• Details of Technical Staff e.g. Manufacturing Chemist and Analytical Chemist with education documents and approval certificates which is applicable
• List of machinery and laboratory equipment
• Site Mater File
• Blue print of Plant and layout of premises specifying installation of machinery and equipments
• Design and Layout of HVAC system
• List of medicines to be manufactured in manufacturing unit
• Water analysis report etc

Read few article related to Loan licensing:

• Pharma business at third party/loan licensing basis..
• Difference between loan license, third party and pcd/franchise.

Hope above information is useful to you…  
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