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

  1. 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
  2. http://cdsco.nic.in/writereaddata/bio_div_vacc/check_tl_form_11.pdf

 

 

 

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