Return to Table h-1 footnote g referrer. The requirements also apply to all regulatory transactions see Table 2 in section 1. Appendix H of this guidance for sample structure and Table H-1 for the requirements. Should not contain any scientific information. Health Canada recognizes that bookmarks are generated automatically from document headings, but nevertheless recommends they be kept concise. Return to table G-2 footnote 6 referrer. You should only submit separate PBRERs for different products with the same active substance if this was agreed when your MA was granted.
File names should describe the content in a meaningful way and must be limited to a maximum of 50 characters, including the file extension. Information which provides a business advantage as a result of the fact that it is kept confidential. If additional information is required, it will be requested. Check the European reference data EURD list for the exact submission date relating to the active substance in your product, which overrides the general cycle above. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
Heads of Medicines Agencies: PSUR
I can’t find what Pvrer looking for. Return to table G-2 footnote 5 referrer Table G-2 footnote 6 Insofar as this information is not relevant for the applicant. Return to table G-2 footnote 3 referrer Table G-2 footnote 4 Insofar as the information is also relevant for the applicant.
Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. The finished product e. In addition to the above general requirements, the cover letters for: Manufacturers submitting any subsequent information must clearly identify the Application Lettr of the relevant application.
Marketing authorisation templates | European Medicines Agency
With the exception of the file extension, the file naming convention within each folder is left to the stakeholder preparing the regulatory transaction. 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.
Description of the figure H If additional information is required, it will be lettet. Medical Devices Figure H To help demonstrate this in your risk-benefit evaluation you need to include sources. Written correspondence related covfr data protection under section C.
See figure F-2 in Appendix F for an illustration. Clinical Trial regulatory transactions should be sent directly to the appropriate Directorate Footnote 7. A side by side comparison table letyer all changes as per Draft Guidance Document: Regulatory transactions provided by email should meet the following requirements: Veterinary drug regulatory transactions should be sent directly to the veterinary drugs directorate VDD Footnote Return to table G-1 footnote 5 referrer Table G-1 footnote 6 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.
Marketing authorisation templates
Cover letters may be submitted in electronic-only format. A paper cover letter is required as this is the only means by which to quickly identify the content of the media. The cycle may also be different if you were given specific conditions when you applied for your MA. Is this page useful? Table G-2 footnote 5. It is important that PDF files be properly Hyperlinked: Return to table 1 footnote c referrer.
Division 8 Figure E If the PRAC recommends regulatory action e.
Empty folders must be deleted from structures before filing to Health Canada. Table 3 footnotes Table 3 footnote 1 Required only for Clinical Trial regulatory activities.
Periodic benefit risk evaluation reports for medicinal products
For more details about solicited and unsolicited information, see Section 5. Media should be scanned using current virus-scanning software and should be certified virus-free. Description of lerter Figure 2: Return to table G-1 footnote 4 referrer Table G-1 footnote 5 Insofar as this information is not relevant for the applicant.