Health Products and Food Branch Inspectorate

Transcription

1 Our Mandate: To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary); medical devices and natural health products, collaborating with and across, all regions. Health Products and Food Branch Inspectorate Blood Establishment Licence Application: Forms and Instructions FRM-0354 Date issued: October 17, 2014 Date of implementation: October 23, 2014 Disclaimer: This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.

2 INTRODUCTION This application form is intended for blood establishments to use when: - Applying for a Blood Establishment Licence (BEL) - Amending a BEL - Submitting administrative changes - Submitting other supporting documents associated to a BEL - Cancelling a BEL Guidance on submission requirements for these various application types can be found in the Blood Establishment Licence (BEL) Application Checklist. GENERAL INSTRUCTIONS PART A: ESTABLISHMENT INFORMATION In this section, Establishment Name refers to the legal name of the establishment to which the BEL is/will be issued. The address in this section should refer to the head office of the establishment (not necessarily where the activities are being conducted). PART B: ATTESTATION SIGNATURE This section is to be completed by a Senior Executive Officer upon every application. PART C: CANADIANBUILDING INFORMATION and PART D: OTHER ESTABLISHMENT INFORMATION The building(s) of the applying establishment, in which the activities are conducted in Canada, are identified in PART C: CANADIAN BUILDING INFORMATION. If some or all of the activities are done by another establishment either domestic and/or foreign, on behalf of the applying establishment, this Other Establishment information should be entered in PART D: OTHER ESTABLISHMENT INFORMATION. If activities are being conducted in more than 1 building, copy and paste the Part C and/or Part D template as many times as required to enter additional buildings, and/or other establishments, respectively. Additional information/clarification can be provided within the cover letter. As per the definitions provided, check all components in respect of which activities are proposed to be conducted. Do not fill in the shaded areas. ** Other Activity and Other Component can only be included if previously cleared with Health Canada by contacting blood_sang_questions@hc-sc.gc.ca. Activity Definitions: Allogeneic: In respect of blood or a blood donation, means that the blood is collected from an individual either for transfusion into another individual or for use in the manufacture of a drug for human use. Designated donation: Means a blood donation that is made by a donor who is selected for medical reasons to make the donation for a specific recipient. Directed donation: Means a blood donation that is made by a donor who is known by the recipient and selected for medical reasons by the recipient s physician. Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 2 of 10

3 A. Donor suitability assessment: Means an evaluation of a donor that is based on all of the following criteria: (a) the donor s medical history; (b) the results of any donor tests and physical examination; and (c) the donor s social history, to the extent that it is relevant in determining the presence of risk factors for diseases transmissible by blood. Donor tests: As per the establishment s authorization, may include measurement for hemoglobin/hematocrit, serum protein, blood pressure, temperature and weight. B. Collection: Refers to collection of whole blood for transfusion or for use in the manufacture of a drug for human use. C. Collection by Apheresis: Refers to the process of withdrawing blood from a donor, separating specific blood components from the blood and returning the remaining blood components to the donor. This procedure may be performed manually or by automated methods. D. Component Preparation: Any activity performed following the collection of blood up to and including the determination of safety. This includes, but is not limited to end labelling and storage. E. Testing: For allogeneic donations, in accordance with the establishment s authorization, testing may include: ABO/Rh Transmissible disease Clinically significant red cell antibodies Bacteriological (platelets) F. Importing: Refers to the importation of blood for transfusion from outside Canada. Note: Importation does not include blood that is of a rare phenotype not available in Canada and that is imported in accordance with a prescription. F. Distribution: Distribute does not include to transfuse. For example, distribution occurs when establishments send blood to another establishment or when the transfusion medicine laboratory sends blood to the operating theatre or the ward. G. Quality Control Testing: For allogeneic donations, in accordance with the establishment s authorization, the routine testing of blood to ensure that specifications are met. Component Definitions: 1. Whole Blood: Unaltered, anticoagulated blood collected from a donor. 2. & 9. Red Blood Cells: A blood component containing red cells concentrated through the removal of most of the plasma by sedimentation, centrifugation, or cytapheresis of whole blood. 3. Cryoprecipitate: A plasma component produced from frozen plasma and containing a specified amount of fibrinogen or a plasma component prepared from fresh frozen plasma and containing specified amounts of factor VIII and fibrinogen. 4. & 10. Platelets: A blood component consisting of a suspension of platelets in plasma or an approved storage solution, prepared by centrifugation of whole blood or by plateletpheresis. 5. Platelets Pooled Pre-Storage: Whole blood derived platelet units that are pooled prior to storage and determined safe for distribution. Note: this is in contrast to platelet units that are pooled after being placed in storage and prior to transfusion. 6. Cryosupernatant Plasma: Plasma from which the cold-insoluble precipitate has been removed. Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 3 of 10

4 7. & 13. Plasma For Further Manufacture: Plasma derived from a single donation of whole blood or plasma collected by plasmapheresis that is intended for use in producing a drug for human use, known as recovered plasma and source plasma, respectively. 8. Blood Samples for Testing: Samples of blood collected for testing, such as ABO/Rh, transmissible disease and clinically significant red cell antibodies. 11. Granulocytes: A suspension of granulocytes in plasma prepared by apheresis or prepared manually from whole blood. 12. Fresh Frozen Plasma: Plasma separated from the blood of an individual donor or collected by apheresis and placed at 18 C within 8 h of collection from the donor. 14. Frozen Plasma: Plasma separated from the blood of an individual donor or collected by apheresis and placed at 18 C within 24 h of collection from the donor. Examples of registration scenarios: 1. A contracted domestic testing laboratory (applicant) conducting testing on blood samples as per authorization for ABO/Rh, transmissible disease and clinically significant red cell antibodies would check off 8:E in Part C. 2. An establishment (applicant) processing (donor suitability assessment, collection, component preparation and testing) red blood cells from whole blood and conducting quality control testing of red blood cells as per authorization would check off 1:A, 1:B, 2:D, 2:G, and 8:E in Part C. 3. An establishment (applicant) processing (donor suitability assessment, collection, component preparation and testing) red blood cells collected by apheresis and conducting quality control testing of red blood cells as per authorization would check off 9:A, 9:C, 9:D, 9:G and 8:E: in Part C. 4. An establishment (applicant) contracting out transmissible disease testing to a foreign testing laboratory would fill out the foreign establishment s information and check off 8:E in Part D. 5. An establishment (applicant) that imports red blood cells processed (donor suitability assessment, collection, component preparation and testing) by a foreign establishment from whole blood, would check off 2:F in Part C, and in Part D, would fill out the foreign establishment s information and check off 1:A, 1:B, 2:D, 8:E and 2:F. EVIDENCE TO DEMONSTRATE COMPLIANCE OF FOREIGN ESTABLISHMENTS Please refer to Section 18(1)(k) of the Blood Regulations and Pages of the Blood Regulations Guidance document. The applicant must provide sufficient evidence to demonstrate that the foreign establishments meet the requirements of the Blood Regulations. If approved, these foreign establishment(s) will then be listed on the BEL of the establishment in Canada. Sufficient evidence includes, but is not limited to, the following information: - a list specifying the activities conducted at each building of that foreign establishment; - a certificate from a Health Canada Inspector; or - in the absence of a certificate from a Health Canada Inspector, the following documentation demonstrating that the foreign establishment meets the requirements of the Blood Regulations must be filed: a. The most recent (within the last 3 years) signed inspection report issued by i. a regulatory authority with which Canada has a Mutual Recognition Agreement e.g. Therapeutic Goods Administration (Australia), or ii. an authority which is a member of the Pharmaceutical Inspection Cooperation/Scheme [PIC/S]), e.g. United States Food and Drug Administration; b. The corrective actions taken, if any, signed by a responsible official of the foreign establishment; c. A copy of the foreign establishment s procedures for handling deviations and out of specification test results; d. A copy of the quality agreement between the foreign establishment and the Canadian establishment including a list of the specific blood and blood components for supply in Canada; Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 4 of 10

5 e. The Site Master File or equivalent document. It is recognized that in some cases certain documentation may not exist. In such cases, a written justification explaining why the required documents cannot be filed should be provided to the Inspectorate, along with other documentation that encompasses the required information. Note: If these documents are not provided in their entirety, the application will be considered incomplete and will be screened out. APPENDIX 1: ADDITIONAL INFORMATION This section is optional; completing it will help facilitate the inspection process. Blood inventory in this section, is defined as blood that is already determined safe for distribution (i.e. released inventory). ADDITIONAL TOOLS For a copy of Frequently Asked Questions (FAQ) regarding establishment licences and registrations under the Blood Regulations Please contact blood_sang_questions@hc-sc.gc.ca Additional information can be found within the Guidance Document: Blood Regulations: ADDITIONAL QUESTIONS ABOUT BLOOD ESTABLISHMENT LICENSING? Please send your inquiries to: blood_sang_questions@hc-sc.gc.ca READY TO SUBMIT? 1. Prepare an with Blood Establishment Licence (BEL) in the subject line of the and attach the completed BEL application to accelerate the triage of your application. 2. Send the with the form to: ELapplicationLE@hc-sc.gc.ca 3. You will receive an automatic reply acknowledging receipt of the sent. Please maintain records of submitting the application as well as the automatic receipt issued by our systems. Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 5 of 10

6 BLOOD ESTABLISHMENT LICENCE (BEL) APPLICATION CHECKLIST (to be submitted with your application) APPLICATION TYPE New Application [Regulatory Reference: section 17 & 18] Administrative Changes (affecting Part A and/or B) (to be submitted as soon as possible) [Regulatory Reference: section 23 (a)] Cessation of Licensed Activities (affecting Part C and/or D) (to be submitted within 30 days after the cessation of any licensed activity) [Regulatory Reference: section 23 (b)] Amendment (affecting Part C and/or D) (licence to be amended before making the change(s)) [Regulatory Reference: section 22] Evidence to Demonstrate Compliance of Foreign Establishments [Regulatory Reference: section 18 (1) (j)] Cancellation (to be submitted within 30 days after the cessation of all licensed activities) TO BE COMPLETED Copy of Authorization (if available; except for testing under a pre-assessed donor program) Cover letter (recommended) Entire Application (where applicable) Appendix 1 Compliance information (if applicable) Cover letter (recommended) Part A Part B Cover letter (recommended) Part A Part B Revised Part C and/or D reflecting the removed activities Copy of revised Authorization (if available; except for testing under a pre-assessed donor program) Cover letter (recommended) Part A Part B Revised Part C and/or D reflecting the activities to be maintained as well as the changes Compliance information (if applicable) Cover letter (recommended) Part A Part B Part D Compliance information (if applicable) Part A Part B [Regulatory Reference: section 29] Please put Blood Establishment Licence or BEL in the subject line of the and submit the completed BEL application form, along with supporting documents (if applicable), to: ELapplicationLE@hc-sc.gc.ca Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 6 of 10

7 BLOOD ESTABLISHMENT LICENCE (BEL) APPLICATION FORM PART A: ESTABLISHMENT INFORMATION Blood Establishment Licence # (if applicable): Application Tracking # (for internal use only): Establishment Name: Previous Name of Establishment (if applicable): Establishment Civic Address Building Name (if applicable): Street Number: Street Name: Suite: City: Province: Postal Code: Postal Address (where correspondence is to be sent) same as above Street Number: Street Name: Suite: Post Office Box: City: Province: Postal Code: Contact Information (for correspondence regarding the application) Contact Person and Title: Language: English French Telephone: Fax: Emergency Contact Person (24/7 or outside business hours) Contact Person and Title: same as above Language: English French Telephone: Fax: PART B: ATTESTATION SIGNATURE (to be completed by a Senior Executive Officer) In accordance with Section 18(1), the information provided in this application is accurate and complete. This Blood Establishment has sufficient evidence to demonstrate that it can conduct its activities in accordance with its quality management system and the requirements of the Blood Regulations and that its activities will not compromise human safety or the safety of blood. Name of Senior Executive Officer: Title: Signature: Date (yyyy-mm-dd): Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 7 of 10

8 PART C: CANADIAN BUILDING INFORMATION (where activities are being conducted) Building Name (if applicable): Building Letter (assigned by Health Canada): Address Information same as Establishment Address (Part A) same as Postal Address (Part A) Street Number: Street Name: Suite: City: Province: Country: Canada Postal Code: Records Storage Address same as above same as Establishment Address (Part A) Street Number: Street Name: Suite: City: Province: Country: Canada Postal Code: Activity and Component Information Activity Allogeneic, Directed and Designated **Other Activity (as applicable) A. Donor Suitability Assessment B. Collection C. Collection By Apheresis D. Component Preparation E. Testing F. Importing Component G. Quality Control Testing H: I: J: 1. Whole Blood Red Blood Cells Cryoprecipitate Platelets Platelets Pooled Pre-Storage Cryosupernatant Plasma Plasma For Further Manufacture (Whole Blood) Blood Samples For Testing Red Blood Cells (Apheresis) 10. Platelets (Apheresis) Granulocytes Fresh Frozen Plasma Plasma For Further Manufacture (Apheresis) Frozen Plasma ** Other Component (as applicable) 15: 16: ** Other Activity or Other Component can only be included if previously cleared with Health Canada by contacting Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 8 of 10

9 PART D: OTHER ESTABLISHMENT INFORMATION (if any) Establishment Name: BEL # (if applicable): Street Number: Street Name: Suite: City: Province/state: Country: Postal/Zip Code: The above establishment is associated with the following building(s) (address or building letter): Activity and Component Information of Other Establishment (conducted on applicant s behalf) Allogeneic, Directed and Designated Activity **Other Activity (as applicable) A. Donor Suitability Assessment B. Collection C. Collection By Apheresis D. Component Preparation E. Testing Component F. Distribution G: H: I: 1. Whole Blood Red Blood Cells Cryoprecipitate Platelets Platelets Pooled Pre-Storage Cryosupernatant Plasma Plasma For Further Manufacture (Whole Blood) Blood Samples For Testing Red Blood Cells (Apheresis) Platelets (Apheresis) Granulocytes Fresh Frozen Plasma Plasma For Further Manufacture (Apheresis) Frozen Plasma ** Other Component (as applicable) 15: 16: ** Other Activity or Other Component can only be included if previously cleared with Health Canada by contacting Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 9 of 10

10 APPENDIX 1: ADDITIONAL INFORMATION Question 1: Does your establishment have a standalone blood inventory storage facility? Yes No If yes, please provide the following information: Building name (if applicable): Street Number- Street Name: Suite: City: Province: Country: Postal Code: Question 2: Does your establishment use a contracted standalone blood inventory storage facility? Yes No If yes, please provide the following information: Name of Establishment: Previous Name of Establishment (if applicable): Street Number- Street Name: Suite: City: Province: Country: Postal Code: Blood Establishment Licence Application: Form and Instructions (FRM-0354) /October 17, 2014 Page 10 of 10