If your submission date is not on the EURD list, it will be:. Table Sample folder structures for specific regulatory activity types are illustrated in the locations indicated below:. Dates for phasing out paper filing Regulatory Activity and subsequent transactions Paper Table 1 footnote d will no longer be accepted as of: Response to a request for clarification: The requirements also apply to all regulatory transactions see Table 2 in section 1. In addition to the above general requirements, the cover letters for:
The Dossier Identifier should be a letter “d” followed by 6 numbers. Response to a request for clarification: Medical Devices A cover letter, for medical device class II regulatory activities, is only required when including relevant information that does not have a placeholder in the application form or structure. A paper cover letter is required as this is the only means by which to quickly identify the content of the media. Examples of content for specific folders:
Files provided electronically should not be password protected.
Heads of Medicines Agencies: PSUR
For human drugsthese should be placed in folders 1. The Dossier Identifier should be “f” followed by seven numbers.
The first update, for the existing MF in paper format, must include a complete MF conversion in an electronic-only format. The media formats acceptable when providing electronic regulatory transactions are: Regulatory transactions provided by email should meet the following requirements: PDF versions of documents should be generated from electronic source documents and not from scanned letger, except where access to an electronic source document is unavailable or where a signature is required.
You should also include the results of any new studies carried out on the safety of your product around off-label use, with a summary of their impact.
Transactions for human drugs provided on approved media formats should be sent to OSIP regardless of the review Directorate except in the below cases: Additional specific requirements for transactions accepted via email include: Insofar as the information is related to the detailed description of the manufacturing process and the MF Owner sufficiently justifies that there is no need to control these impurities in the final drug substance.
Table G-1 footnote 7. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Multiple documents provided as a single PDF file is not acceptable. Presentations for meetings with Health Canada e. Covef G-1 footnote 4.
Maybe Yes this page is useful No this page is not useful Is there anything wrong with this page? Clinical Trial Applications Figure D-1 – displays a sample folder structure requirement for a response to a clarification request.
Periodic benefit risk evaluation reports for medicinal products
Return to coveg G-1 footnote 6 referrer. See Appendix A for full contact information. Return to table G-2 footnote 6 referrer Table G-2 footnote 7 Insofar as the information is pbrrer to the detailed description of the manufacturing process and the MF Owner sufficiently justifies that there is no need to control these impurities in the final drug product. Stakeholder Footnote 11 Name and Role e. Health Canada is pleased to announce a revision to the Guidance Document: Should not contain any scientific information.
Table G-2 footnote 8.
Health Canada recognizes that bookmarks are generated automatically from document headings, but nevertheless recommends they be kept concise. Description of the Figure C Responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters must be provided in a question and answer format and be accompanied by a copy of the original Health Canada lettsr.
Each document should have only one PDF file.
Published 18 December Last updated 18 February — see all updates. It is the responsibility of the stakeholder preparing lehter regulatory transaction to ensure that hyperlinks are functioning. With the exception of the file extension, the file naming convention within each folder is left to the stakeholder preparing the regulatory transaction.
Top Level Folder Name: This will apply for all products lefter those only approved in the UK. Appendix H of this guidance for sample structure and Table H-1 for the requirements The zipped sample structures in Appendix H; Guidance on supporting evidence to be provided covwr new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic; Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic device licence applications and amendments.
Further information on the repository, including how to register to use the submission tools can be found here.