The top level folder should be included every time a regulatory transaction is provided to Health Canada. Medical Devices 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; Guidance Document: The sponsor assumes the risk of transmitting Protected B information through email. Each document should have only one PDF file. Support Center Support Center.

Lowercase letter followed by six 6 or seven 7 unique numbers depending on the regulatory activity type. Involving an experienced pharmacovigilance medical writer in a scientific writing team ensures this and enables the pharmacovigilance and medical experts to focus on their core task of ensuring patient safety. Refer to the Guidance Document: The dossier identifier consists of two segments:. The zipped file should be named:

Please review our privacy policy. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. If only one page of a multi-page document requires a signature, the sponsor should scan that page and then include the scanned page at the same location in the PDF file of the document. Cover letters may be submitted in electronic-only format. To help demonstrate this in your risk-benefit evaluation you need to include sources.


The top level folder should be included every time a regulatory transaction is provided to Health Canada. Empty folders should not be included in the structure i. The standard pharmacovigilance guidelines and regulations including 21 CFR part Manufacturers submitting any subsequent information must clearly identify the Application Number of the relevant application.

It is important that PDF files be properly Hyperlinked: Good Manufacturing Practices Certificate of Compliance. Return to Table h-1 footnote a referrer. If multiple regulatory activities or transactions are being submitted, each will require a separate email.

Marketing authorisation templates

It shows that a folder name using a letter “p” or “h” followed by 6 numbers should be used as the “Dossier Identifier”. Medical Devices Figure H 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.

Return to table G-2 footnote 4 referrer. Basics of clinical development of a drug[ 9 ]. Regulatory Activities provided in electronic-only format have been accepted by Health Canada since The attached zipped folder structure in the HTML version of this document can be used by adding documents in their respected folders.

An eight 8 digit numerical code assigned to each drug product approved under the Food and Drugs Act and Regulations.

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

Contact OSIP for other file formats that may be acceptable at the time of filing. Return to table G-2 footnote 2 referrer Table G-2 footnote 3 Detailed information. Eg, distribution of case reports, seriousness and labelling assessment, or literature screening – Artificial Intelligence, where the system can interpret and analyze the source, select the appropriate content, and perform end to end case processing by machine learning.


Clinical Trial Ocver for clver clarity. Return to Table h-1 footnote c referrer. Return to table G-1 footnote 1 referrer.

cover letter pbrer

By the DLP, covr request for regulatory input in a template-specific format is sent to the regulatory team. Veterinary Drugs When providing a master file for a veterinary drug, the MF version number should be provided.

cover letter pbrer

Division 5 Clinical Trial regulatory activities should include relevant protocol number s. Find out more about cookies or hide this pbger. Quality Chemistry and Manufacturing Guidance: 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:.

Division 1 Table 1 footnote a e.

The frequency of submission is quarterly for first 3 years followed by annually. Return to table G-1 footnote 3 referrer.