Letter - Annual Review of Drug Establishment Licences (DELs) for 2012

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Contact Information

Health Products and Food Branch Inspectorate
Graham Spry Building, 2nd Floor
250 Lanark Avenue
Address Locator #2002A
OTTAWA, Ontario
K1A 0K9
July 29, 2011

To: Establishment Licence Holders

Re: Annual Review of Drug Establishment Licences (DELs) for 2012

This notice is to initiate the 2012 Annual Review process for Drug Establishment Licences.

What has changed?

Establishment Licences will no longer expire on December 31^st of each year.

Pursuant to amendments to the Food and Drug Regulations (FDR), Drug Establishment Licences issued by Health Canada will no longer expire on December 31^st of each calendar year. A licence issued pursuant to section C.01A.009 (1) (2) of the FDR, will remain valid as long as an application for annual review is submitted before April 1^st of each year. However, if there is information available to Health Canada, for instance, issues identified through a Good Manufacturing Practice (GMP) inspection, it may result in suspension of an existing licence. Establishments operating without a valid licence and performing any regulated activity would be in contravention of Section C.01A.004 of the Food and Drug Regulations and be subject to compliance and enforcement action.

As of April 1^st, 2011 the Health Canada sticker on an Establishment Licence will no longer indicate a date. It should be noted however, that terms and conditions and foreign sites annexes, where applicable, will continue to be assigned expiry dates.

Applicable Fees must accompany applications.

In addition to the above changes, amendments to the User Fees Act require that as of April 1^st, 2011, payment must accompany the following application types: new and amendments if applicable, as well as applications for annual reviews. Applicants submitting applications without appropriate payment will be invoiced for the amount owing and will have 30 days to pay before interest is accrued.

What has not changed?

The existing fee regulations governing Veterinary Drugs Use Establishment Licences will continue to be in place and payment will be invoiced after the licence is issued and new applicants will have 90 days after the end of their calendar year to have their fees remitted.

If the total payable fee in section 4 to 10 of Establishment Licensing Fees Veterinary Drugs Regulations (SOR/98-4) is an amount that is greater than 1.5% of the applicant's actual gross revenue generated from activities conducted under a DEL during the previous calendar year, fee remission will be granted. The amount remitted will equal the difference between the total applicable fees and the amount of 1.5% of gross revenue.

The 2011-2012 Annual review Process

Licences issued with a December 31^st 2011 expiry date will continue to be valid until April 1^st, 2012.

For this year, in order to re-issue licences with new stickers with no expiry date, before April 1^st, 2012, completed application packages along with payment, must be received by Health Canada before August 22, 2011. Applications must be supported by the required renewal documentation, including acceptable foreign sites evidence of GMP compliance for importers and if applicable, fee deferral or fee remission requests. These documents should be submitted to the Establishment Licensing Unit, at the address listed below. Failure to return the completed application along with the supporting documentation by this date may either result in the delay of the issuance or no renewal of your Establishment Licence.

Note:
If you are no longer conducting licensable activities as per Division 1A of the Food and Drug Regulations, please submit in writing that your company wishes to withdraw its drug establishment licence and the date at which licensable activities ceased. For return address information, please refer to the contact information below.

Please refer to the attached checklist and relevant documentation for completing your application. Application Completion Checklist once completed along with an endorsement that payment has been included, should be appended to the completed application package.

Relevant Documentation

The following information is available on the Health Canada website and can be accessed on the Establishment Licences website.

• Drug Establishment Licence Applications:  Form and Instructions (Including fee form)
• Drug Establishment Licence Fees Calculation Charts; (Please email the Establishment Licence Invoicing Unit in order to obtain the instructions as well as the Calculation Chart at ELIU_UFLE@hc-sc.gc.ca)
• Alternate Sample Retention Site Application Form;
• Intention to Invoke Section 37 Form (for fabricators only);
• Good Manufacturing Practices (GMP) and Establishment Licences (EL) Issues document;
• Contract Sterilization Letter;
• Guidance on Evidence to demonstrate Drug GMP compliance of foreign sites (GUI-0080); and
• Pre-Application GMP package for Importers, Distributors and Wholesalers.

Fee Deferral and Fee Remission

If an applicant does not make the request in the application, there will be no fee remission for that particular transaction.

If an applicant for human use or human and veterinary use only, has not completed its first full calendar year of conducting activities under any DEL, the payment of the applicable DEL fee is deferred until the end of that first full calendar year. "Calendar year" means a period of twelve consecutive months commencing on January 1^st. In this case, applicant will need to complete the Fee Form to be considered for a payment deferral.

If an applicant for human use or human and veterinary use only, has completed one calendar year of conducting activities under an establishment licence and wishes to be considered for a fee remission, they must submit at the time of application along with their completed application forms, a Certified Statement of Revenue, payment, a completed Fee Form and a completed Calculation Chart.

If the applicable DEL fee for human use or human and veterinary use only is calculated in accordance with the schedules to Part 2, Division 2 of the Fees In Respect of Drugs and Medical Devices Regulations and is an amount that is greater than 1% of its actual gross revenue generated from activities conducted under a DEL during the previous calendar year, fee remission will be granted.

The amount remitted will equal the difference between the total applicable fees and the amount of 1% of the applicant's actual gross revenue. For more information on fees and how to submit payment, please see the following:

• Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002)
• How to Pay Fees

Please note that fee remission or fee deferral requests, where applicable, must accompany applications or else they will not be considered.

Should you require further assistance please contact:
Establishment Licensing Unit:
Tel: 613-954-6790
Email: DEL_questions_LEPPP@hc-sc.gc.ca

Billing and Invoicing Section:
Tel: 613-946-5141
Email: ELIU_UFLE@hc-sc.gc.ca.

Please note that we will endeavour to respond to all inquiries within 15 days of receipt.

Submissions Information

Mail: Establishment Licensing Unit
2nd Floor, Graham Spry Building
Address Locator 2002D
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
Fax: 613-957-6711 or 613-957-4147

Yours truly,

Original signed by

Diana Dowthwaite
Director General