Article by: Rachelle D’Souza, Regulatory Heights Inc.
The Annual Drug Notification Form (ADNF) is intended to assist manufacturers in complying with section C.01.014.5 of the Food and Drug Regulations which requires that every manufacturer of a drug confirms annually before October that all information previously supplied with regard to that drug is correct.
Health Canada would like to inform manufacturers of changes to the information that is included in the Annual Drug Notification Form (ADNF). These changes are, in part, due to the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) (the Regulations). These regulations were published in the Canada Gazette, Part II on June 29, 2016 and will come into force on March 14, 2017. Other changes have also been made to the ADNF in an effort to streamline the process.
The significant changes to the information included in the ADNF, and how it will affect manufacturers, are summarized below. These changes will be incorporated in the upcoming ADNF, which will be sent to manufacturers in June of 2017.
The inclusion of these changes to the ADNF will bring the annual notification process into compliance with the Regulations. Furthermore, it will increase the accuracy of the information presented in the Drug Product Database Online Query (DPD).
1. Drug products which have been assigned a Drug Identification Number (DIN), but have not been marketed (Approved Products), will now be included as a separate list in the ADNF, in an effort to encourage manufacturers to cancel the DINs they do not intend to market in Canada. This will allow the Department to ensure that the drug information provided on the Department's website is accurate and up to date. It will also be beneficial for manufacturers as they will have a complete list of all their DINs in one report on an annual basis. With the implementation of this change, the biennial DIN Assigned Project, which had manufacturers clarify the status of their "Approved Products" in a separate report, will be eliminated.
2. In accordance with section C.01.014.7 of the Regulations, for drug products that were marketed but are noted as being discontinued on the ADNF, manufacturers will be required to provide the discontinuation date, the lot number and the expiry date of the last lot sold by the manufacturer. This information will be recorded on a separate form that will be provided with the Annual Drug Notification Form.
3. Drug products which are marketed but have not had sales for 12 consecutive months (Dormant Products) will be included as a separate list in the ADNF. Additionally, in accordance with section C.01.014.12 (1) of the Regulations, there will be an option for manufacturers to note if a marketed product has become a dormant product.
If you have any questions regarding this notice, please contact OSIP, TPD, Email: sipdannual_annuelledppr@hc-sc.gc.ca, Telephone: 613-946-1151, Facsimile: 613-954-3067
Regulatory Highlights
Updated: GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars