A guide to filling out Health Canada Exemption Applications

Transcription

1 Page 1 of 16 A guide to filling out Health Canada Exemption Applications A controlled substance exemption is a document issued by Health Canada authorising you to possess a specific quantity of a controlled substance to be used solely for the scientific purposes outlined in your approved protocol. If you are in possession of a controlled substance without proper authorisation, you are considered to be trafficking under the Controlled Drugs and Substances Act. More information regarding specific controlled substance exemptions can be found at: Before you can apply for an exemption license you need to have an approved protocol in IRISS. This guide shows the application section by section, with excerpts of the application itself in a hatched border, and additional definitions or information following the excerpt. After the final section, there are instructions regarding submission of the exemption application and some frequently asked questions.

2 Page 2 of 16 Section 1: Application Type New If you have never submitted an application for your protocol If you are renewing an exemption application that has expired Extension (no additional quantities) To extend the expiry date of your exemption, but do not require any additional quantities of your controlled substances and no changes have been made to your protocol that affect your exemption (e.g. changes to staff do not affect it, but changes to protocol activities will) No additional quantities means in Section 5 of the application, you have enough of the controlled substances in your inventory (lab) for the protocol for one year, and will not be ordering any more Extension (additional quantities): To extend the expiry date of your exemption, but require additional quantities of the substance for which you are exempt Additional quantities means in Section 5 of the application, you do not have enough of the controlled substances in your inventory (lab) for the protocol for one year, and will need to order more Amendment of a valid exemption: This is used when an exemption is still valid and you need to alter some details of your exemption; examples would include adjustments to animal numbers, dosages, of the controlled substances themselves *If your exemption expires within the next 2-3 months when you submit the amendment, Health Canada may extend your expiration date. As this is dependent upon who reviews your submission, do not leave any submissions to the last minute. Usually an amendment will only make changes to your current exemption (retaining the current expiry), there is no guarantee they will also extend your expiration date. Cancellation of a valid exemption: This is used when the study is finished and you therefore no longer need the controlled substances. When an exemption is cancelled, all remaining controlled substances that were outlined on the exemption must be destroyed. Transfer of controlled substances from one researcher to another within an institution: This is used when you are transferring a protocol to another PI, and therefore need to transfer the exemption as well so they can continue to use the controlled substances. Depending on the nature of the transfer some additional documents may be required Ensure that your current authorization number is included in the box below your selection if this is not a new application.

3 Page 3 of 16 Section 2: Identification 2.1: Provide the title and name of the Principal Investigator, this must be the PI listed on the protocol. If it is Transfer of controlled substances from one researcher to another within an institution this information would be that of the incoming PI. 2.2: State the PI s qualifications and contact information and identify an alternate contact person. 2.3: State the location where the substance will be used. This information should be listed in the Animal Sites section of your IRISS protocol.

4 Page 4 of : Mailing address, only fill out if location is different than section 2.3, if these locations are the same check Same as above address (e.g. if section 2.3 is the lab you are using the controlled substance in, but you have a different office room number, then this would be filled out as the mailing address in section 2.4). 2.5: Only fill this section out if your controlled substances will be stored at an address not listed in either Section 2.3 or 2.4. If one of these Sections is your storage address, then check the corresponding box here.

5 Page 5 of 16 Section 3: Project Study Description Project title: Provide the full title of your protocol as seen in IRISS including the protocol number. Required Documents: Protocol Attached: If this is a new application or amendments are being made then you need to include a paper copy of your IRISS protocol. If you are submitting your application via , save a PDF copy of your protocol. Protocol Previously Submitted: If there have been no amendments to your previously submitted protocol then you do not need to include a copy of your protocol. Approval of the Animal Care Committee: For any studies that are in vivo a copy of the signed Animal Care Committee Approval Certificate must be included. This is found at the top of your protocol homepage alongside the heading Certificate of Approval. If you are submitting via , this will be a PDF copy, if you are mailing your application then you will need to print a paper copy. Briefly include a description of how you plan on using the substance. Ex: Ketamine will be used for anesthesia, Sodium pentobarbital will be used for euthanasia. If submitting anything other than a New application you must provide a reason for submitting the application. Ex. Protocol was renewed so experiments are ongoing.

6 Page 6 of 16 Section 4: Details of Administration **Please note, this section is only filled out when all three of the above conditions are met. At the University of Calgary this is highly unlikely. In this section you must first indicate whether it is an in vitro or in vivo study. **Please note, in order to not require an exemption, all three of the listed conditions must be met. This is highly unlikely when conducting research at the University of Calgary. Next identify the species the study will be conducted on, you do not have to be specific (saying swine is acceptable, no need to specify they are white landrace, etc.). The number of animals will include the total being used for one year (this is important, as the calculations in section 5 are for one year of your study). If you are combing 2 or more protocols under 1 exemption license then this will be the total of all the animals used for all protocols. Then list the average weight of the animals (this should be in grams or kilograms). Indicate the method of disposal for the animal carcasses.

7 Page 7 of : List the dosages for each controlled substance you are using per animal. If you have more than two controlled substances to be named, as many copies of this page may be included with the application as needed. Dosing of the drugs should be written out in mg/kg. The dosages and frequency are those outlined in your Animal Care Committee approved protocol.

8 Page 8 of 16 Section 5: Supplier of the Controlled Substance In this section state the total quantity of the substance(s) for which you need to be exempt and the supplier of the controlled substance. Keep in mind that exemptions are only valid for one year, and therefore this section is to be filled out as requirements for one year. The supplier must be a Health Canada licensed controlled substance supplier. The VSRS is not a licenced controlled substance supplier. LESARC and HSARC are licenced suppliers, and for those with LESACC or HSACC protocols these will likely be your suppliers. Please note: Sodium Pentobarbital 54.7mg/mL is no longer available in Canada. If you are unsure which supplier to use please refer to the attached document (also available on the Animal Health Unit website here: If you are unsure of the substance concentration contact your supplier. Please see the next page for steps in calculating your quantity to be purchased. If you have more than two controlled substances, as many copies of this page may be included with the application as needed.

9 Page 9 of 16 Using the information provided in Section 4, calculate the total quantity required of your controlled substance(s) in ml from a mg/kg dosing: First, determine the total milligrams required: mg= (number of animals) x (animal weight in kg) x (total dose of substance in mg/kg) Use the total milligrams required (calculated above) to determine the total millilitres required: ml= (total mg required) x (1/concentration of substance) Here is an example calculation for a study using 100 mice at 30g each. The concentration of the substance is 100mg/mL, and the dose needed is 100mg/kg. Total milligrams required: 100 x 0.03kg = 3kg (weight of all mice being used) 3kg x 100mg 1kg = 300 mg required Total millilitres required: 300 mg x 1mL = 3mL required 100mg

10 Page 10 of 16

11 Page 11 of 16 Section 6: Physical Security Describe how the substance will be stored. Substances are required to be located in a safe or cabinet that can be locked. The unit used to store the substance must be affixed to either the wall or floor. However, if the safe is located within another storage container (i.e. a locked drawer, cabinet, etc.) that is fixed to the floor or wall, the safe is considered fixed by associated. You must indicate that the room where the substances are stored does not have public access and that the room is locked. Ex: The substances will be stored in a safe affixed to the wall within the Experimental Imaging Centre, this room is locked, alarmed and has restricted access More information on storage requirements can be found on the Health Canada Website Directive on Physical Security Requirements for Controlled Substances : *Please note that under an exemption you are not allowed more than $5000 (street value) worth of controlled substances in your inventory.

12 Page 12 of 16 Section 7: Declaration 7.1. Sign here if the application is New, and Extension or an Amendment (as identified in Section 1) 7.2. Sign here if the application is a Cancellation. Here you must indicate if there is a remaining balance of your controlled substances and how you plan on disposing of these quantities The outgoing PI as well and the incoming PI must sign this section if the application is a Transfer of controlled substances from one researcher to another within an institution. You must indicate which substances are being transferred and the remaining quantity. Depending on the nature of the transfer you may need additional paperwork. 8. Submitting your application All portions of an application for exemption may be submitted electronically. Health Canada now accepts electronic signatures, so there is no need to mail in a hard copy of the declaration/signature page as you can submit this electronically. The protocols, approval letters from animal care committees and the application itself may be sent by as PDF documents. The address to send your application to is: hc.exemption.sc@canada.ca Mail: If you prefer to mail a hard copy, you may mail or courier the documents to: Exemptions Section Authorizations Division Office of Controlled Substances Health Canada 161 Goldenrod Drwy AL 0300B Ottawa ON K1A 0K9 *do not forget to include the paper copy of your protocol and your ACC Certificate. Other Information Applications for scientific exemption are processed within 42 business days of receipt of all required documents. This amounts to just over 8 weeks, so it is extremely important you mark down a reminder before your expiry date in order to prevent any delay in your research

13 Page 13 of 16 Health Canada Exemption FAQs What are controlled substances? A controlled substance is any type of drug that the federal government has categorized as having a higherthan-average potential for abuse or addiction. Such drugs are divided into categories based on their potential for abuse or addiction. Controlled substances range from illegal street drugs to prescription medications. For a full listing of controlled drugs click here and refer to the sections labeled "Schedule" (8 sections total at the end of the table of contents). Or for an excel copy of this list, click here. What is a controlled substance exemption or "Section 56 exemption"? A controlled substance exemption is a document issued by Health Canada authorising you to possess a specific quantity of a controlled substance to be used solely for the scientific purposes outlined in your approved protocol. If you are in possession of a controlled substance without proper authorisation, you are considered to be trafficking under the Controlled Drugs and Substances Act. From the Health Canada website: The Controlled Drugs and Substances Act (CDSA) prohibits activities related to controlled substances. Researchers (physicians, veterinarians and other researchers affiliated to universities and private industry) requiring a controlled substance for research purposes which include in vitro utilization, administration to animals or human clinical trial or for special activities (e.g. testing of water quality, screening for drugs of abuse), must receive an exemption under Section 56 of the CDSA. The exemption allows the individual only to possess a specified quantity of the controlled substance and to administer the controlled substance to human subjects or animals for the purpose of research.do I need a controlled substance exemption? If your protocol contains any controlled substances, you require a controlled substance exemption. If your name is on the protocol as the PI, then you will need to have your name on the Exemption Applications regardless of where the study is taking place or whether you or the ARC staff are handling the animals. If you are unsure of which substances are controlled, please visit Health Canada's website and review the Controlled Drug and Substances Act. I have a veterinary license, do I still need an exemption? If you will be using any controlled substances as part of your research, yes, you require an Exemption to use those substances regardless of your veterinary license. Your veterinary license enables you to administer controlled substances to animals as part of their care, but does not allow you to administer controlled substances for research purposes.

14 Page 14 of 16 I already have the controlled substance I require, but I do not have an exemption for them. Do I need to fill out an exemption application since I already have my drug in stock? Yes, you require an Exemption even if you have already ordered and received your controlled substances. To possess and use controlled substances for research purposes without obtaining an Exemption to do so is in contravention of the Controlled Drug and Substances Act and as such is considered drug trafficking. In section 5 of the application, there is a field to declare the quantity of a controlled substance you currently have in inventory and the quantity you intend to purchase from your supplier. If you do not intend to use more than you currently have in stock, put "0" in the "to be purchased" field. How long will it take to receive my exemption license? Applications for scientific exemption are processed within 42 business days of receipt of all required documents. This amounts to just over 8 weeks, so it is extremely important you mark down a reminder before your expiry date in order to prevent any delay in your research Do exemption licenses expire? And how do I renew? Yes, Exemptions are only active for one year. Your Exemption period begins on the day Health Canada issues your Exemption authorization letter and ends one year from that date. Controlled substances may not be purchased after the Exemption is expired, regardless of any 'unused' portion remaining on your Exemption. If you have controlled substances remaining in stock when your Exemption is due to expire, you must submit an 'extension' application to use and possess those controlled substances. The exemption renewal process is near identical to the initial application process - the same application form is used and you are required to provide Health Canada with your current, approved protocol and Animal Care Committee approval certificate. It typically takes between 4 to 6 weeks for Health Canada to issue an Exemption from when they receive your application, but can take as long as 8 weeks during busy periods, regardless if this is the initial application or renewal application. As such, if possible, it is extremely important that you submit your application at least four weeks prior to your exemption expires so that your study will not experience any significant delays while you wait for your renewed controlled substance Exemption. Am I able to make an amendment to my exemption license? Amendments are made in the same fashion as an original application. The same form is used, but in the first section (Application Type) "Amendment of exemption would be selected.

15 Page 15 of 16 Who does my exemption license cover? As per Health Canada, conditions regarding who may use the exempted controlled substance are outlined in the issued exemption as follows: "Colleagues, assistants, technicians, etc. participating in the same project, who are under the researcher s direction and control, are also exempted to the same extent and for the same purpose as the researcher is. The researcher is responsible for any portion of the controlled substance listed that is used by such an individual" How can I transfer responsibility of controlled substances exempted for scientific purposes? This application can be send in to Health Canada. Who are our controlled substance suppliers? The supplier must be a Health Canada licensed controlled substance supplier. The VSRS is not a licenced controlled substance supplier. LESARC and HSARC are licenced suppliers, and for those with LESACC or HSACC protocols these will likely be your suppliers. For all campuses, the only supplier for Sodium Pentobarbital 54.7mg/mL is McGill University. Each supplier is dependent upon what substances you will need, and you can find this information in the supplier table on page 8 of this guide If you are unsure which supplier to use please refer to the attached document (also available on the Animal Health Unit website here: What are the security requirements for possessing controlled substances? In accordance with Health Canada s Directive on Physical Security Requirements for Controlled Substances, controlled substances must be kept in a locked primary container (i.e. strongbox or safe) that is located inside of a locked secondary container (i.e. a locked room). Only designated personnel can have access to these containers. Typically, Health Canada recommends your controlled substance should be stored in a "safe" (a container made of metal that can be locked, i.e. a lock box, locked fridge, or an actual safe) that is fixed to the floor or wall. However, if the "safe" is actually located within another storage container that is fixed to the floor or wall, such as a locked drawer or cabinet, then you can consider the safe "fixed" by association. You are also required to maintain accurate records of the controlled substances you have on hand and how/when they were used (i.e. vial number; quantity (volume and concentration); date received; animal species for which the controlled substance was issued; etc.).

16 Page 16 of 16 Can I send an electronic copy of my exemption application? Yes! You can send all portions of an application for exemption electronically to hc.exemption.sc@canada.ca Please ensure that copies of all current approved protocols, proof of current approval by a local animal care committee (for in vivo administration) are included with the application and that the declaration on page four is signed and dated. If I choose to mail my application, what is the mailing address? Mail the completed application with your approved protocol and ACC certificate to: Exemptions Section Authorizations Division Office of Controlled Substances Health Canada 161 Goldenrod Drwy AL 0300B Ottawa ON K1A 0K9 What is the procedure to destroy/discard a controlled substance? As an exemption holder, there will be a section on the exemption itself outlining the procedure Health Canada required for destroying/discarding controlled substances. Who can I contact for additional help? For information on the Exemption process or to check the status of your exemption, please contact Health Canada at hc.exemption.sc@canada.ca To determine if substances are considered controlled, please contact hc.statusdemandedestatut.sc@canada.ca For information on drug suppliers, drug concentrations and quantities, or how to order substances, please contact your ARC: Health Sciences ARC: arcsurg@ucalgary.ca Life and Environmental Sciences ARC: dmarti@ucalgary.ca Veterinary Sciences Research Station: greg.boorman@ucalgary.ca For help filling out the application or general exemption questions you can contact acc.drugexemption@ucalgary.ca