With the exception of the file extension, the file naming convention within each folder is left to the stakeholder preparing the regulatory transaction. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. When providing a MF conversion, identical copies of all previously filed Letters of Access are recommended to be provided one letter per pdf file with the name of the company, to whom access is granted, as the pdf file name. 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 letter. Unsolicited information such as safety information and changes in the name of the company or product during review. For example when there are different formulations of the active substance with significantly different indications. Health Canada requires the following information for all cover letters:

S Drug Substance AP 3. Description of the Appendix B: Aggregate reports have timelines for submission, and hence, the author needs to be proactive in considering all the possible risks which may delay report and act accordingly. Table G-1 footnote 5. Commonly used and meaningful abbreviations, such as QOS for Quality Overall Summary, may be used to shorten file names. Return to table G-1 footnote 6 referrer.

Authoring a periodic adverse drug experience report…here’s what you need to know!

Documents of ten pages or more should be bookmarked. You may be able to use some of the same modules in the development safety update report DSUR and or risk management plan in the PBRER to minimise duplication and improve efficiency.


leter Brand name, MF name or Device name Control number, Leyter number, MF number or Application number if known Dossier identifier if known Regulatory activity type Any cross-referenced regulatory activity should be clearly stated date the regulatory activity was approved. As part of an ongoing efficiency measure and efforts to reduce regulatory burden on industry as well as to transition to an electronic environment, Health Canada has established the following options that are available immediately for filing regulatory activities in scope of this document and their related transactions: Table G-2 footnote 3.

Open in a separate window. Once the first marketing authorization approval international birth date is obtained by a MAH, a reporting cycle starts and first quarterly PADER needs to be submitted within 30 pvrer. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product.

A side by side comparison table listing all changes as per Draft Guidance Document: Failure to provide the complete electronic copy of the MF will result in the MF being suspended no further access for review will be granted and no update will be accepted for the MF.

The body of the email should only contain the zipped regulatory transaction; no other documents or related information should be included.

Marketing authorisation templates

Manufacturers submitting any subsequent information must clearly identify the Application Number of the relevant application. When providing a MF conversion, identical copies of all previously filed Letters of Access are recommended to be provided one letter per pdf file with the name of the company, to whom access is granted, as the pdf file name.


cover letter pbrer

To help demonstrate this in your risk-benefit evaluation you need to include sources. File names should describe the content in a meaningful way and must be limited to a maximum of 50 characters, including the file extension. Zip file – 9 K.

cover letter pbrer

Email should be addressed to the requestor s identified in the clarification request. In addition, the following are exceptions to this requirement:. Insofar as the information is related to the detailed description of the manufacturing process, control of materials and process validation.

PADER also covers a statement on number of cases reported where the medicinal product is reported as a co-suspect medication.

Brahmachari B, Bhatt A.

cover letter pbrer

Return to table G-2 footnote 7 referrer. A collection of all regulatory transactions throughout the process of a specific activity.

Heads of Medicines Agencies: PSUR

Table 1 footnotes Table 1 footnote a Lettrr administrative regulatory activities and transactions. Clinical Trial regulatory transactions should be sent directly to the appropriate Directorate Footnote 7.

Guidance Periodic benefit pbeer evaluation reports for medicinal products. O Table 1 footnote g. Quality Chemistry and Manufacturing Guidance: See figure F-2 in Appendix F for an illustration. Cver and Content of a Regulatory Activity. Cover letters may be submitted in electronic-only format. Return to table G-1 footnote 3 referrer Table G-1 footnote 4 Insofar as the information is also relevant for the applicant.

Please select all that apply: Return to table 1 footnote 2 referrer Table G-1 footnote 3 Detailed information. Duplicate copies are not required.