Changes to the Annual Drug Notification Form (ADNF)
Posted: Monday August 21st, 2017
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc.
Editor: Madhur Jadawala, B.Sc. Pharm. Quality & Compliance Services Inc.
On March 14, 2017, Health Canada published a notice outlining upcoming changes to the Annual Drug Notification Form.
The intent of Annual Drug Notification Form (ADNF) is to help manufacturers in complying with section C.01.014.5 of the Food and Drug Regulations that mandates every manufacturer of a drug to confirm annually (before October) that all information previously provided related to that drug is correct.
The upcoming changes are, in part, due to the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) which were published in the Canada Gazette, Part II on June 29, 2016 and have been enforced as of March 14, 2017. Other changes have also been made to the ADNF in an effort to streamline the process. Health Canada believes implementation of these changes will increase the accuracy of the information presented in the Drug Product Database Online Query (DPD).
Here is the list of significant changes pertaining to the information included in the ADNF:
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 Food and Drug Regulations, for drug products that were marketed but now 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 Food and Drug Regulations, there will be an option for manufacturers to note if a marketed product has become a dormant product1.
These changes have been incorporated in the ADNF sent to manufacturers in June of 2017.
1. The requirement to report the Dormant Products as per section C.01.014.12 (1) of the Regulations only applies to the following drugs for human use:
a. drugs included in Schedules I, II, III, IV or V to the Controlled Drugs and Substances Act
b. prescription drugs;
c. drugs listed in Schedules D and C to the Act
d. drugs that may be sold without a prescription, but are administered only under a practitioner's supervision