Form 30 for application of Test Licence

FORM 30

[See Rule 90]

Application for licence to manufacture drugs for purposes of examination, test or analysts

1. ………………............................ of …………………………… ……… by occupation ………………............ here by apply for a licence to Manufacture the drugs specified below for Purposes of examination, test. or analysis at ………............. and I undertake to comply with the conditions applicable to the licence.

Names of drug,

Date…………………………
Licensing Authority …………..………

Form 29 Test Licence Application Procedure

(As per the current guidance obtained from http://www.fda-mah.com)


Grant of Licence to manufacture drugs for purposes of examination, test analysis

Food and Drug Administration M.S. grants Licence to manufacture drugs for purposes of examination,test analysis in Form 29.

Procedure to obtain Licence to manufacture drugs for purposes of examination, test analysis. (Fresh) 
Stage 1 
Application for grant of Licence to manufacture drugs for purposes of examination, test analysis. 
The applicant has to make application in the requisite Form 30 and pay necessary fees as given in Appendix A.

Fee can be paid in cash at Head Office/Division as well as any other District Officer.The fee can also be paid through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head Account -----

210 - Medical and Public Health.
04 - Public Health
104 - Fees and Fines, etc

Documents to be attached along with the application form:

• Receipt for the fees paid or challan, (the fees are as given in Appendix A) as the case may be or their attested copies.
  
• Copy of layout plan of the area (incase of applicants applying for the first time).
  
• Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.
  
• Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application.
  
• Details of the product.
  For drug composition of which the drug is not generally recognized a No objection certificate from the Drug Controller General India.
  

Download
Application Form 30
Details of Fees Appendix A 

Quality By Design for Modified Release products

Generic Modified Release Drug Products

Formating of Bio Equivalence Summary Tables

Quality by Design_ANDA_Modifies release tablets

Quality by Design for ANDAs_MR Tablets

FDA interpretation of 505(b)(2)NDA

FDA interpretation of 505(b)(2) NDA

first something about me..

I am S.K, a pharmacy graduate and working in the regulatory affairs profession since 2002..So that marks a decade :)

i started this blog on a whim sitting on a  chair and working on my PC. I am a blog fan and read lots of blogs on various topics and i just love them..They enrich us in so many good ways..

A tip: Every RA person should possess this reading quality..lots and lots of reading..anything..just read..

I have been lately coming across so much of hype and hoopla about Regulatory affairs and all the freshers trying to get in to this...and not the least all alumnus of RA are utilizing this opportunity to mint money by providing so called training in RA to these freshers but do you yourself realize, did they themselves had to go to any such training to achieve these..answer is NO..you can learn (well, almost) basics of regulatory in these offered courses but definitely not worth the money paid..

Our education system should have the RA subject so students do not have to look for alternate means to know about regulatory and spend additional hard earned money when they already spent so much during their college days.

i want my blog to have everything i know , i read about regulatory...but definitely that does not mean i will be revealing all my confidential organizational information...

this is only about what as a regulatory i have understood and perceived over the years in a very simplified and absolute free way to all interested in knowing about regulatory affairs. my confessions of the. "THE REAL REGULATORY AFFAIRS" .