DIN application

No one can sell a drug without having received an authorization from Health Canada.  The approval of a drug is confirmed by the issuance of a DIN which means Drug Identification Number.  There are different types of DIN applications and the requirements in terms of documentation to file with Health Canada are quite different.  No additional evidence of efficacy is required for Category IV and label standard types of  DIN applications.  But for new drug applications whether it is for a generic or an innovative drug, safety and efficacy data are required.  It is also prior to marketing a drug that one must study its stability in order to establish its period of validity, create the specification of the drug and validate the manufacturing process.
we ca assits your group in the preparation of DIN submission.