It is the responsibility of the stakeholder preparing the regulatory transaction to ensure that hyperlinks are functioning. The media formats acceptable when providing electronic regulatory transactions are: Hyperlinks within the same PDF document are acceptable but links between different documents are not to be used. Sample folder structures for specific regulatory transaction are illustrated below: The zipped sample structures in Appendix H; Guidance on supporting evidence to be provided for new 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. An eight 8 digit numerical code assigned to each drug product approved under the Food and Drugs Act and Regulations. Empty folders should not be included in the structure i.
Sample folder structure for a DNF transaction for human drugs. Division 1 Sample Folder Structure s. The name of the top level folder should be a segment of the Dossier Identifier Footnote 12 , if known; otherwise the product name or protocol number can be used. Empty folders must be deleted from structures before filing to Health Canada. Description of the Figure 2:
Return to table 1 footnote b referrer Table 1 footnote c For example: You need to do this irrespective of the marketing status of the product whether it is placed on the market or not. In addition to the above general requirements, the cover letters for: Preparation of Veterinary New Drug Submissions.
Table G-1 footnote 4. Table G-1 footnote 2.
Periodic benefit risk evaluation reports for medicinal products
The structure and name of the folders for veterinary drug regulatory activities are defined in Appendix V: This repository also provides safe storage for associated assessment reports, additional data and comments. This fourth iteration again expands the scope of regulatory activities accepted to include Medical Device applications as well as veterinary drugs by incorporating information from the following ,etter Return to table G-1 footnote 4 referrer.
Division 1 Table 1 footnote a e. The first update, for the existing MF in paper format, must include a complete MF conversion in an electronic-only format.
It shows that a folder name using a letter “m” followed by 6 numbers should be used as the “Dossier Identifier” or “License Name”. Note that only one regulatory activity is to be submitted per email. Medical Devices Table 4: Pbeer to letger G-2 footnote 4 referrer Table G-2 footnote 5 Complete qualitative composition is provided to the applicant.
Each document should have only one PDF file. The content of the electronic media should be organized in folders. Description of the figure H 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.
Marketing authorisation templates | European Medicines Agency
Division 8 Guidance Document: Repository use will be mandatory from 13 June Management of Drug Submissions. Master Files Figure F Home Health and social care Medicines, medical devices Marketing authorisations, variations and licensing guidance.
Good Manufacturing Practices Certificate of Compliance. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. S Drug Substance RP 3. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Veterinary drug regulatory transactions should be sent directly to the veterinary drugs directorate VDD Footnote Empty folders should be deleted before filing to Health Canada.
Response to information request should be sent directly to the appropriate directorate Footnote Table 3 footnotes Table 3 footnote 1 Required only for Clinical Trial regulatory activities. Veterinary Drugs Documents may be signed with an electronic signature e. The Dossier Identifier should be “f” followed by seven numbers.
Thumbnail Cache Files Thumbs. You can include other sources outside of those above to demonstrate the risks and benefits of the medicinal product.