Table G-1 footnote 3. See Appendix A for full contact information. The structure and name of the folders for veterinary drug regulatory activities are defined in Appendix V: MF conversions including a new Letter of Access, that has not previously been authorized, should be identified so it can be processed and acknowledged. P Drug Product 3.
Return to table 1 footnote d referrer. P Drug Product RP 3. This is true whether the information is tangible or intangible. Rules of thumb for good bookmarking include: The body of the email should only contain the zipped regulatory transaction; no other documents or related information should be included. This applies even if the products have different names and are granted through different procedures e.
Return to table 1 footnote a referrer Table 1 footnote b The first update, for the existing MF in paper format, must include a complete MF conversion in an electronic-only format.
Marketing authorisation templates
For lettter details about solicited and unsolicited information, see Section 5. Description of the Figure E With the exception of the file extension, the file naming convention within each folder is left to the stakeholder preparing the regulatory transaction.
Clearly state what is being provided and the reason for filing, for example: To help us improve GOV. The structure and prber of the folders must be provided using one of the following formats: 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.
R Regional Information 1 3. Return to table G-1 footnote 4 referrer Table G-1 footnote 5 Insofar as this information is not relevant for the applicant. 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.
This should include all:. If the PRAC recommends regulatory action e.
Heads of Medicines Agencies: PSUR
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. This will apply for all products including those only approved in the UK.
MF conversions including a new Letter of Access, that has not previously been authorized, should be identified so it can be processed and acknowledged. These transactions include, however are not limited to, the following: 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.
The Dossier Identifier should be “f” followed by seven numbers. Technical Requirements for Regulatory Activities. Medical Devices Table 4: 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 notices:.
Marketing authorisation templates | European Medicines Agency
Return to table G-1 footnote 4 referrer. When providing an update, a new MF application form should be provided.
It is the responsibility of the stakeholder preparing the regulatory transaction to ensure that hyperlinks are functioning. The Lehter Identifier should be a letter “d” followed by 6 numbers. The zipped ,etter structures in Appendix H; Guidance Document: Description of the figure H Zipped files and documents contained in the email should not be password protected.
Medical Devices Figure H The structure and name of the folders for veterinary drug regulatory activities are defined in Appendix V: Examples of content for specific folders: Return to table 1 footnote 2 referrer.
Regulatory transactions provided by email should meet the following requirements:. Too many levels of bookmarks are inefficient; in most instances, four levels of bookmarks should be sufficient: Division 1 and Division 8 Second language product monographs or prescribing information should only be provided to Health Canada via email to sipd-din hc-sc.
If your submission date is not on the EURD list, it will be: