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Best Practices for Submitting Drug Establishment Licence (DEL) Applications

March 25, 2019

From Health Canada:
 
Dear Stakeholder,
Since 2011 Health Canada has been issuing decisions for DEL applications whenever a portion of an application is ready. This allowed applicants to obtain decisions on components of applications in a timely manner. However, Health Canada’s performance is monitored based on the number of applications completed, which is when a decision is issued for all the portions of the application.

Reporting by application type

Health Canada has repeatedly received feedback from applicants requesting that performance standards and performance reporting be modified to be based on application type rather than using a performance standard of 250 days for all types of applications. These changes have been requested to improve predictability of approvals and assist companies in the planning of the introduction of new products to the Canadian market. However, such reporting is not possible if applicants continue to submit applications that pertain to multiple buildings in a single application.
 
As such, Health Canada is requesting that when submitting amendment applications, applicants submit applications on a per building basis; that is, they include only a single component in a single application rather than multiple components. More information is provided below on best practices for separating applications. This approach will not be applied to applications for a new DEL.

Change to process - Issuing decisions on applications received

Health Canada requires the collaboration of every applicant to submit their amendment applications following the attached guidance to support optimal performance reporting. Applications that are not separated cause challenges in realizing the objective of reporting performance on application types.
 
To that effect, Health Canada will change its issuance practices to discontinue the issuance of decisions on portions of applications as they are ready for licensing. Health Canada will issue a decision per application, as it is submitted to Health Canada. If an application contains amendments for several buildings, the decision will be issued only once a decision for all buildings is ready to be rendered.
 
  • This new approach would apply to applications submitted on or after June 1, 2019. 
  • Applicants are encouraged to start separating their applications immediately following the guidance available below.
  • Health Canada is proposing this approach to encourage companies to separate their applications and support Health Canada’s effort to improve its reporting on performance. 

Guidance on how to split applications

Application for a new DEL
Please continue to submit applications for new DELs by including in the application every Canadian and foreign building for which the license is requested. These applications should not be separated and will not be subject to the new issuance practices at this time.
 
Amendment Application for existing DEL
Administrative changes:
Administrative changes to an existing DEL should always be submitted separately from other types of requests (e.g. separate from requests to add activities, drug categories, dosage form…). Administrative changes include changes to:
  • Mailing or billing address
  • Name, telephone number, fax number and email address
  • Warehouse information.

Foreign building applications

Applications to add, renew or amend a foreign building should be submitted with only one foreign building per application. Multiple changes can be requested for the foreign building in the same application; however, each application should only be for a single foreign building.
 
As an exception, when GMP evidence covers multiple buildings, every foreign building covered by the evidence can be grouped into a single application.
 
Additionally, when applying to add or amend a foreign building to your DEL, all drug categories, activities, sterility status and dosage forms requested for the foreign building must be authorized at the domestic building level. When this is not the case, the application must also include a request to amend the associated domestic building to add the missing drug category, sterility status or dosage form under the activity of import.
 
Canadian building change:
Applications to amend or add a Canadian building to the DEL should be submitted individually. Multiple changes can be requested for the same building in one application. However, the application should only be for a single Canadian building.
 
Note about importation:
  • When submitting an amendment to add the activity of import to an existing DEL, whether adding a new building or adding import to an existing building, the application must include a request to add at least one foreign building. When the applicant wishes to apply for the addition of multiple foreign buildings, the application should include all the foreign buildings requested in the application. This is only applicable when the application is to add the activity of import to a DEL.

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