dossier meaning in pharmaceutical industry

For information on the company ID (company code) refer to the sections 2.3 Company Enrolment/Amendment of the Guidance Document: The Regulatory Enrolment Process (REP): Drugs for Human/Veterinary Use and Disinfectants. Based on the request, Health Canada will confirm the dossier ID.Ĭompany ID (or company code): is a 5 digit unique number assigned by Health Canada to the manufacturer/sponsor company. If you are unsure what your product dossier ID is, submit a completed dossier ID request form.

For information regarding DSTS-IA, or for account set up, please contact the Office of Submission and Intellectual Property by sending an e-mail to: In addition, previously issued correspondence, such as acknowledgment letters or screening acceptance letters, may be used to retrieve the dossier ID. You may proceed by completing the RT XML template and send the regulatory transaction via the common electronic submission gateway (CESG).ĭossier IDs for existing submissions filed with Health Canada can be obtained from the Drug Submission Tracking System – Industry Access (DSTS-IA). If you are using the REP, have existing dossier ID, and are continuing to file in the same format (eCTD or non-eCTD), there is no need to request a dossier ID.

When filing in non-eCTD format using the Regulatory Enrolment Process (REP).ĪA request for a dossier ID should only be placed a maximum of four weeks prior to filing a regulatory transaction.

When switching from non-eCTD electronic-only format to eCTD format.The format of the dossier identifier (ID) is a lowercase letter followed by six (6) unique numbers.Ī dossier ID must be requested prior a to filing the first regulatory transaction: A dossier is a collection of all regulatory activities throughout the life cycle of a product for a stakeholder.

Dossier meaning in pharmaceutical industry