News & Updates

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31st March 2016 - Health Canada DMF Electronic Conversion for all paper submission

02th Mar 2016 I Sumit Gupta

 

 

Health Canada regulatory body for Canada has gone electronic, they have stopped accepting paper submission for all DMFs from 1st January 2016 and further more all old submissions made prior to 1st Jan 2106 have to be converted in electronic format (Non eCTD) before 31st March.

Failure to comply will lead to DMF being suspended no further access will be provided for review and no DMF updated will be accepted. We in this write up are looking to help you with this decision by discussing the various Positives and negatives of both these options.

 

 

Source - Health Canada (( http://www.hc-sc.gc.caa))
Companies who will be affected by above notice areCompanies who will be affected by above notice are

 1) Type I - Drug Substance or Intermediate in the production of Drug Substance
 2) Type II – Container Closure System and other primary packaging material like- Glass container, plastic bottles, caps, liners, sealing wads, silicone tube,  collapsible tubes, plastic tubes, aluminum foils, laminates etc
 3) Type III – Excipients – Includes DMFs for Colorants, flavors, Capsule shells, alum, growth media, coating ingredients etc.
 4)  Type IV – Dosage Form –Natural Health Products, Veterinary & human

With less than 1 month remaining for 31st March 2016, companies should look to gear up the regulatory department and submit electronic copy of their submission to Health Canada asap to keep their DMF Active.     

If you have any queries or want to convert your existing DMF to electronic version for submission

please contact at gupta2@eth.net or call on 9890512558.

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   4. PPC has more than 30 years of Regulatory experience in Pharmaceutical field  we can help you :
   5. a) Convert existing Paper Submission to eCTD
   6. b) File Annual report/ Amendment in eCTD format with US FDA , Health Canada , EU nations, and other eCTD Accepting countries.
   7. c) We write , compile and submit Drug Master file for US FDA and other countries

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