The subject line of the email should include one of the following statements: The attached zipped folder structure in the HTML version of this document can be used by adding documents in their respected folders. Regulatory transactions for human drugs , that contain an HC-SC form should include a table, structured as below, placed at the end of the cover letter. Master Files Figure F To help demonstrate this in your risk-benefit evaluation you need to include sources.

Return to table G-2 footnote 7 referrer Table G-2 footnote 8 Insofar as the information is related to the detailed description of the manufacturing process, control of materials and process validation. Description of the Figure 3: Preparation of Veterinary New Drug Submissions. Thank you for your feedback. Response to a request for clarification: Functional Classification Standard Code:

P Drug Product AP 3.

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This form should be sent via mail or fax separately. Return to table G-2 footnote 6 referrer Table G-2 footnote 7 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 product.

As a corollary to the above, it is equally important to note that Health Canada reserves the lettee to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a product.


Description of the Figure ,etter Should not contain any scientific information. Return to table G-2 footnote 1 referrer Table G-2 footnote 2 A flow chart including all manufacturing steps, excipients and processing agents and a short description can be sufficient, if additional detailed information is presented in the Restricted Part.

UK uses cookies to make the site simpler. Zip file – 9 K. Hyperlinks within the same PDF document are acceptable but links between different documents are not to be used. The media formats acceptable when providing electronic regulatory transactions are: The zipped file should be named: Sections, subsections, tables, figures, and appendices should all be bookmarked.

Heads of Medicines Agencies: PSUR

Master Files Figure F Description of the Figure 2: Report a problem or mistake on this page. Health Canada requires the following information for all cover letters: Table G-2 footnote 6. Empty folders must be deleted from structures before filing to Health Canada. Division 8 Guidance Document: See Appendix F for illustrations.

Periodic benefit risk evaluation reports for medicinal products

Sample folder structure for a DNF transaction for human drugs Figure 3 – displays a sample folder structure requirement for DNF transactions.

To consolidate several notices regarding different product lines that are letted in different locations into one single document for ease of access by stakeholders. Division 8 Sample Folder Structure s.


The maximum email size ketter by the corporate mail server is 20 megabytes, anything larger should be sent on media. Return to table G-1 footnote 4 referrer Table G-1 footnote 5 Insofar as this information is not relevant for the applicant.

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You will not receive a reply. Pbret to table 1 footnote 2 referrer Table G-1 footnote 3 Detailed information. The structure and name of the folders must be provided using one of the following formats: Email should be addressed to the requestor s identified in the clarification request.

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.

Marketing authorisation templates

Medical Devices Figure H Sample folder structure for a DNF transaction for human drugs. Published 18 December Last updated 18 February — see all updates.

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Skip to main content Skip to “About government”. Division 8 Table 1 footnote a e. S Drug Substance RP 3.