Changes to the Annual Renewal Process of Canadian Drug Establishment Licences

Author: Author Madhur Jadawala

OVERVIEW

Effective 2017 Annual Licence Renewal (ALR) of Drug Establishment Licences (DEL), Health Canada has added an extra step to the ALR submission process by DEL holders. This change constitutes of an addition of a MS Excel sheet known as “Product List” and it has been provided to all the DEL holders along with the 2017 ALRs packages.

WHO DOES THIS APPLY TO?

·         All the Canadian Drug Establishment Licence (DEL) holders who wish to renew their importation DEL and maintain its active status. Although the name of this new sheet is “Product List”, not only it covers the list of drug products (DINs) imported by the importer DEL holder but also the foreign sites and their activities corresponding to these DINs.

WHAT’S NEW

·         An accurately completed “Product List” Excel sheet must now be submitted along with the ALR package to Health Canada every year by March 31. Health Canada may issue Screening Deficiencies in case where “Product List” is not provided or is not completed appropriately.

Refer to Figure 1 below for the snapshot of the “Product List” issued by Health Canada:

·         As it is evident from Figure 1 below, Health Canada has already pre-filled the “Product List” with the information they have on their records, and yes, it may not be completely comprehensive. One may find some activities or foreign sites that are actively listed on their DEL but are missing from this “Product List”. This is fine, for Health Canada has provided us with this sheet so that we can add more details and submit the most accurate and comprehensive sheet along with the renewal before March 31st.

·         The Excel sheet may seem to be fairly simple at first sight but there is a lot of fact finding and information search involved behind before one can completely fill this sheet with high accuracy. There are clear instructions in cell “H1” for listing only 1 DIN per cell, and this is where it becomes a bit tricky.

·         Health Canada wants us to use each row to list each foreign site carrying out each activity for each DIN. As an example, if a foreign site “Foreign Site 1” is involved in Fabrication, Packaging and Labelling of DIN 01234XXX, this needs to be listed in 3 separate rows for each activity as illustrated in Figure 2 below.

·         Many times, a single foreign site is involved in carrying out licensable activities for more than 1 DIN product. As an example, “Foreign Site 2” is involved in Fabrication and Packaging of 2 DIN products – 01234XXX and 01234XXY. In this case, both the DINs need to be entered separately in separate rows corresponding to Fabrication and Packaging by “Foreign Site 2” as illustrated in Figure 2 below.

·         Health Canada has limited gathering of this information to activities of “Fabrication, Packaging and Labelling” only. Foreign sites involved in “Testing” only need not be listed on this “Product List”.

Figure 1: “Product List issued by Health Canada”

Figure 2: “Product List issued completed by DEL holder”

*Different Colours for DINs 01234XXX and 01234XXY have been used to demonstrate that these are two separate unique DINs.