DMF Submission in Mexico

Mallappa

Starting to get Involved
#1
Dear All,

Need your kind help for the below questions.

Product in scope: Radiopharmaceutical preparation and is a prescription drug

We got to know that there is no requirement for DMF registration COFEPRIS in Mexico. The submission of the Applicant`s part together with the whole product dossier, which will be done by the MAA, will be sufficient., please confirm

  1. It is possible to submit the drug substance dossier DMF (DIFA) directly to COFEPRIS by mail.
  2. Is English accepted? For DMF and submission documents? Or is a translation to Spanish necessary? If yes, can translations be done in Austria (accredited translator)?
  3. Where we should submit the DMF to? exact address and contact person?
  4. Is CTD or eCTD accepted in Mexico?
  5. It seems that we have first to submit the DMF, afterwards we will get a submission/dossier number and then we have to resubmit again referring to this number. Please confirm?
Looking ahead for your kind response,

Thank you in advance!
 
#2
Dear All,

Need your kind help for the below questions.

Product in scope: Radiopharmaceutical preparation and is a prescription drug

We got to know that there is no requirement for DMF registration COFEPRIS in Mexico. The submission of the Applicant`s part together with the whole product dossier, which will be done by the MAA, will be sufficient., please confirm

  1. It is possible to submit the drug substance dossier DMF (DIFA) directly to COFEPRIS by mail.
  2. Is English accepted? For DMF and submission documents? Or is a translation to Spanish necessary? If yes, can translations be done in Austria (accredited translator)?
  3. Where we should submit the DMF to? exact address and contact person?
  4. Is CTD or eCTD accepted in Mexico?
  5. It seems that we have first to submit the DMF, afterwards we will get a submission/dossier number and then we have to resubmit again referring to this number. Please confirm?
Looking ahead for your kind response,

Thank you in advance!
Take a look at this site
Acerca de Registrar Corp
It seems they can help you
 

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