Biologicals- Test License
Biologicals- Test License
Form 29 is a licence to manufacture biological for the purpose of Examination Testing and Analysis.
An application for a licence in Form 29 shall be made to the Licensing Authority appointed by the State Government (SLA) for the purpose of this in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.
A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.
A licence in Form 29 shall be subject to the following conditions-
(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;
(b) the licensee shall allow any 4 Inspector appointed under the Act to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied.
References
- Guidance document on grant of licence in form 11(test licence) for the purpose of examination testing and analysis as per rule 33 of drugs and cosmetics acts and rules 1945. Central drugs standard control organization directorate general of health services ministry of health and family welfare government of India. http://www.cdsco.nic.in/writereaddata/GUIDANCE%20DOC.pdf
- http://cdsco.nic.in/writereaddata/bio_div_vacc/check_tl_form_11.pdf