Hyperlinks within the same PDF document are acceptable but links between different documents are not to be used. Too many levels of bookmarks are inefficient; in most instances, four levels of bookmarks should be sufficient: If multiple regulatory activities or transactions are being submitted, each will require a separate email. The finished product e. Glossary of Terms Appendix C:
Five to seven days before DLP, an introductory email with timelines for various activities of a PADER is circulated with the stakeholders, so that they can confirm their availability for the action items. Preparation of Veterinary New Drug Submissions. The Dossier Identifier should be “f” followed by seven numbers. Veterinary drug regulatory transactions should be sent directly to the veterinary drugs directorate VDD Footnote Should not contain any scientific information. 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. If your submission date is not on the EURD list, it will be:
Aggregate safety reports are an important tool in the safety evaluation throughout the life cycle of a medicinal product. The PBRER provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle.
Events of special interest are serious or nonserious events e. Table Sample folder structures for specific regulatory activity types are illustrated in the locations indicated below:.
In addition, the following are exceptions to this requirement: This is true whether the information is tangible or intangible.
Media and files should not be password protected. Regulations in clinical research of drug development. Management of Drug Submissions. Table G-2 footnote 3. Sections, subsections, tables, figures, and appendices should all be bookmarked. 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 days.
However, Health Canada suggests that the file names be kept as brief and meaningful as possible:.
Technical Requirements for Regulatory Activities 3. Should not contain any scientific information. Files stored on the media should not be zipped.
This should include all:. PRAC will create 1 report using a single assessment framework for all products with the same active substance and share it with the relevant MA holders. 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 for new and amended licence lstter 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.
Description of the Figure E However, Health Canada suggests that the file names be kept as brief and meaningful as possible: The requirements also apply to all regulatory transactions see Table 2 in section 1.
Medical device regulatory transactions should be letger directly to device licensing services division.
To consolidate several notices regarding different product lines that are published in different locations into one single document for ease of access by stakeholders.
The current efforts are mainly to automate individual case safety reports processing which includes: Table G-1 footnote 4. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
Periodic benefit risk evaluation reports for medicinal products
Table G-2 footnote 7. To help demonstrate this in your risk-benefit evaluation you need to include sources. Regulatory input is usually received by covee 3—5 of the DLP. The zipped sample structures in Appendix H; Guidance on supporting evidence to be provided for covr 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.
Authoring a periodic adverse drug experience report…here’s what you need to know!
Failure to identify a new Letter of Access in the cover letter, could delay access to the MF due to the absence of an authorized Letter of Access. When providing a revision to the MF the version number should be updated.
It shows that a folder name using a letter “m” followed by 6 numbers should be used as the “Dossier Identifier” or “License Name”.
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