The body of the email should only contain the zipped regulatory transaction; no other documents or related information should be included. Master Files Draft Guidance Document: Any transactions not formatted as per this guideline, will be rejected. Clinical Trial Applications Figure D-1 – displays a sample folder structure requirement for a response to a clarification request. This will apply for all products including those only approved in the UK.
The regulatory transaction should be organised in folders see section 2. Medical device regulatory transactions should be sent directly to device licensing services division. Regulatory transactions provided by email should meet the following requirements:. 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 1 footnotes Table 1 footnote a Including administrative regulatory activities and transactions. The first update, for the existing MF in paper format, must include a complete MF conversion in an electronic-only format.
Description of the Figure 4: Response to a request for clarification: The folder names as defined lerter the above indicated appendix should exclude information in parentheses. Media should be scanned using current virus-scanning software and should be certified virus-free. Leading sheets at the beginning of sub-folders indicating a folder is not applicable or describing the content must not be provided.
Table G-2 footnote 7.
The attached zipped pberr structure in the HTML version of this document can be used by adding documents in their respected folders. Stakeholder Footnote 11 Name and Role e. Written correspondence related to data protection under section C. The sponsor assumes the risk of transmitting Protected B information through email.
Marketing authorisation templates
Table h-1 footnotes Table h-1 footnote 1 If information needs to be included that does not appear somewhere else in the application Return to Table h-1 footnote a referrer Table h-1 footnote 2 Includes fee form, where applicable Return petter Table h-1 footnote b referrer Table h-1 footnote 3 ISO A collection of all regulatory transactions throughout the process of a specific activity.
Return to table 1 footnote b referrer Table 1 footnote c For example: Insofar vover the information is related to the detailed description of the manufacturing process and the MF Pbret sufficiently justifies that there is no need to control these impurities in the final drug product. File names should describe the content in a meaningful way and must be limited to a maximum of 50 characters, including the file extension.
Description of the Appendix B: The PBRER provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle.
Heads of Medicines Agencies: PSUR
It is important that PDF files be properly bookmarked. Follow the good pharmacovigilance practices for guidance on how to report this urgent safety information.
Published 18 December Last updated 18 February — see all updates. Master Files Figure F The subject line of the email should include one of the following statements: 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.
Sample folder structure for a DNF transaction for human drugs. X Table 1 footnote f. Duplicate copies are not required.
Return to table G-2 footnote 6 referrer Table G-2 footnote 7 Insofar as the information is related letger 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. Table G-1 footnote 4. My Service Canada Account.
You can include other sources outside of those above to demonstrate the risks and lette of the medicinal product. Rules of thumb for good bookmarking include: S Drug Substance AP pbrerr.
Future refinements and subsequent iterations of this guidance document will continue to be necessary as a result of the transition from paper format to electronic format. Note that the required hyperlinks to related information should be included only in the PDF version of files.
However, Health Canada suggests that the file names be kept as brief and meaningful as possible: Guidance Periodic benefit risk evaluation reports for medicinal products. Please select all that apply: