GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Blood Regulations — 109
Notice to Minister 109 (1) An establishment that has reasonable grounds to believe that a donor has experienced a serious adverse reaction during a donation or within 72 hours after a donation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of the donor or within 15 days after it learns of the adverse reaction in any other case. Contents of notice (2) The notice must contain all of the following information: (a) a description of the adverse reaction; (b) any actions that were taken to address it; and (c) the outcome. Written notice (3) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Blood Regulations — 110
Required action 110 (1) Subject to section 111 , an establishment that has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction must immediately take all of the following actions: (a) determine the donation codes of all implicated blood; (b) identify and quarantine any implicated blood in its possession; (c) if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction and notify any establishment to which it distributed implicated blood; and (d) if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity carried out by another establishment, notify all of the following establishments: (i) the establishment that collected the implicated blood, (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and (iii) any establishment to which it distributed implicated blood. Contents of notice (2) The notice required by paragraphs (1)(c) and (d) must contain all of the following information: (a) a description of the adverse reaction; (b) an explanation of how the safety of the implicated blood may have been compromised, if known; (c) the donation codes of all implicated blood; (d) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and (e) the name of any suspected transmissible disease or disease agent, if known. Quarantine (3) An establishment that is notified under subsection (1) or under this subsection must immediately notify to the same effect every establishment and other person to which it distributed implicated blood and quarantine any implicated blood in its possession. Investigation (4) An establishment that is notified under subparagraph (1)(d)(i) or (ii) must, if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction. Written notice (5) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Blood Regulations — 111
Autologous donations 111 An establishment that both collects and transfuses the same autologous blood must, if it has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction, immediately quarantine any other blood from that donor in its possession and conduct an investigation into the adverse reaction and the implicated blood.
Blood Regulations — 112
Requirement to cooperate 112 An establishment must, on request, provide every establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused.
Blood Regulations — 113
Notice to Minister 113 (1) An establishment that is conducting an investigation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of a recipient or within 15 days after it learns of any other unexpected adverse reaction or serious adverse reaction. Written notice (2) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Blood Regulations — 114
Results of investigation 114 (1) The establishment that is conducting an investigation must notify in writing every establishment and other person to which it distributed implicated blood of the results of the investigation and of any action that is required to be taken. Notice to be forwarded (2) An establishment that is notified under subsection (1) or under this subsection must send a copy of the notice to every establishment to which it distributed implicated blood.
Blood Regulations — 115
Final report to Minister 115 On completion of the investigation, the establishment must file a final report with the Minister that contains all of the following information: (a) the results of the investigation; (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.
Blood Regulations — 116
Annual report 116 At the end of each year, an establishment must prepare an annual report that summarizes all of the final reports that it filed in the year, including a concise critical analysis of the investigations that were the subjects of those reports, and must file it with the Minister on request.
Blood Regulations — 117
Record quality 117 Records kept by an establishment must be accurate, complete, legible, indelible and readily retrievable.
Blood Regulations — 118
Donation code part of all records 118 An establishment must ensure that the donation code is a component of all of its records that relate to the processing, distribution, transformation and transfusion of blood.
Blood Regulations — 119
Retention periods — allogeneic blood 119 (1) An establishment that collects allogeneic blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. Calculation of record retention period (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 28 of the table, in which case the period begins on the last day on which the employee was last employed by the establishment. TABLE TO SECTION 119 Records and Retention Periods Item Column 1 Column 2 Records Retention period 1 Donor identification code 50 years 2 Donation code 50 years 3 Reconciliation of donation codes 10 years 4 Donor suitability assessment 5 years 5 Determinations of donor unsuitability — indefinite 50 years 6 Determinations of donor unsuitability — temporary 10 years 7 Collection — date of donation 50 years 8 Collection — donor apheresis 5 years 9 Collection — record of donation 5 years 10 Lot number and name of manufacturer of container and other critical supplies for each donation 1 year 11 Test results for transmissible disease testing, ABO group and Rh factor, and clinically significant antibody testing 50 years 12 Blood component preparation 10 years 13 Blood storage temperature monitoring 5 years 14 Destruction or other disposition of blood 50 years 15 Distribution 50 years 16 Shipping documents 1 year 17 Exceptional distribution 50 years 18 Importation in urgent circumstances 50 years 19 Post-donation information 10 years 20 Complaints and their investigation 5 years 21 Internal audit reports 5 years 22 Quality control testing 5 years 23 Maintenance, validation, qualification and calibration of critical equipment 3 years 24 Critical supplies, including their qualification 3 years 25 Proficiency testing 5 years 26 Every version of the operating procedures that was implemented, other than those related to donor suitability assessments 10 years 27 Every version of the operating procedures related to donor suitability assessments 50 years 28 Personnel qualifications, training and competency evaluation 10 years 29 Investigations and reports of errors and accidents 10 years 30 Investigations and reports of adverse reactions 10 years
Blood Regulations — 120
Retention periods — autologous blood 120 (1) An establishment that collects autologous blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. Calculation of record retention period (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 18 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. TABLE TO SECTION 120 Records and Retention Periods Item Column 1 Column 2 Records Retention period 1 Donor identification code 10 years 2 Donation code 10 years 3 Collection — donor record 5 years 4 Lot number and name of manufacturer of container and other critical supplies for each donation 1 year 5 Test results for transmissible disease testing, ABO group and Rh factor 10 years 6 Blood component preparation 10 years 7 Blood storage temperature monitoring 5 years 8 Destruction or other disposition of blood 10 years 9 Distribution 10 years 10 Shipping documents 1 year 11 Complaints and their investigation 5 years 12 Internal audit reports 5 years 13 Quality control testing 5 years 14 Maintenance, validation, qualification and calibration of critical equipment 3 years 15 Critical supplies, including their qualification 3 years 16 Proficiency testing 5 years 17 Every version of the operating procedures that was implemented 10 years 18 Personnel qualifications, training and competency evaluation 10 years 19 Investigations and reports of errors and accidents 10 years 20 Investigations and reports of adverse reactions 10 years
Blood Regulations — 121
Retention periods — transformation 121 (1) An establishment that transforms blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. Calculation of record retention period (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 10 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. TABLE TO SECTION 121 Records and Retention Periods Item Column 1 Column 2 Records Retention period 1 Donation code 10 years 2 Records of washing, pooling and irradiation of blood 10 years 3 Lot number and name of manufacturer of critical supplies for each transformation 1 year 4 Complaints and their investigation 5 years 5 Internal audit reports 5 years 6 Quality control testing 5 years 7 Maintenance, validation, qualification and calibration of critical equipment 3 years 8 Critical supplies, including their qualification 3 years 9 Every version of the operating procedures that was implemented 10 years 10 Personnel qualifications, training and competency evaluation 10 years 11 Investigations and reports of errors and accidents 10 years 12 Investigations and reports of adverse reactions 10 years
Blood Regulations — 122
Retention periods — transfusion 122 (1) An establishment that transfuses blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. Calculation of record retention period (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 11 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. TABLE TO SECTION 122 Records and Retention Periods Item Column 1 Column 2 Records Retention period 1 Donation code — allogeneic blood 50 years 2 Donation code — autologous blood 10 years 3 Shipping documents 1 year 4 Blood storage temperature monitoring 5 years 5 Distribution 50 years 6 Exceptional distribution 50 years 7 Record of transfusion or disposition of allogeneic blood, including identification of recipient 50 years 8 Record of transfusion or disposition of autologous blood 10 years 9 Complaints and their investigation 5 years 10 Every version of the operating procedures that was implemented 10 years 11 Personnel qualifications, training and competency evaluation 10 years 12 Investigations and reports of errors and accidents 10 years 13 Investigations and reports of adverse reactions 10 years
Blood Regulations — 123
Storage of records 123 An establishment must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.
Blood Regulations — 124
Making visual recordings 124 An inspector may, in the administration of these Regulations, take photographs and make recordings of any of the following: (a) any article that is referred to in subsection 23(2) of the Act; (b) any place where the inspector believes on reasonable grounds any article referred to in paragraph (a) is processed, transformed or stored; and (c) anything that the inspector believes on reasonable grounds is used or is capable of being used in the conduct of an establishment’s activities.
Blood Regulations — 126
Deemed authorization 126 The information that is required by section 6 to be included in an application for an authorization and that was filed with and accepted by the Minister under sections C.01A.005 to C.01A.007 and C.01A.014 of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued by the Minister under section 7 of these Regulations.
Blood Regulations — 127
Licence continued 127 If an establishment files an application for a licence under section 18 — without regard to paragraphs (1)(j) and (k) — within three months after the day on which these Regulations come into force, any licence that was issued to the establishment under section C.01A.008 of the Food and Drug Regulations before that day is continued until a licence is either issued under section 20 or refused under section 21 of these Regulations.
Blood Regulations — 128
Delayed registration 128 (1) An establishment that, before the day on which these Regulations come into force, conducts any of the activities mentioned in section 30 may continue to do so without a registration if it files an application for registration under section 31 within three months after that day. Duration (2) Subsection (1) applies until the determination of the application under section 32 .
Blood Regulations — One year after publication
One year after publication * 129 (1) These Regulations — except subsections 4 (4) to (6), paragraph 64 (1)(b) as it applies to registration numbers, and section 125 — come into force one year after the day on which they are published in the Canada Gazette , Part II. Subsections 4 (4) to (6) and paragraph 64 (1)(b) (2) Subsections 4 (4) to (6) and paragraph 64 (1)(b), as it applies to registration numbers, come into force six months after the day on which these Regulations come into force. Section 125 (3) Section 125 comes into force on the day on which these Regulations are registered. * [Note: Regulations, except subsections 4(4) to (6), paragraph 64(1)(b) and section 125, in force October 23, 2014; subsections 4(4) to (6) and paragraph 64(1)(b) in force April 23, 2015.]
Canadian Wheat Board (Interim Operations) Regulations — 1
1 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 2
2 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 3
3 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 4
4 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 5
5 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 6
6 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — 7
7 [Repealed by operation of law, 2011, c. 25, s. 64]
Canadian Wheat Board (Interim Operations) Regulations — Canadian Wheat Board (Interim Operations) Regulations
[Repealed by operation of law, 2011, c. 25, s. 64]
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
Whereas, pursuant to subsection 11(3) of the Motor Vehicle Safety Act a , a copy of the proposed Motor Vehicle Tire Safety Regulations , substantially in the form set out in the annexed Regulations, was published in the Canada Gazette , Part I, on February 11, 2012 and a reasonable opportunity was afforded to interested persons to make representations to the Minister of Transport with respect to the proposed Regulations;
Motor Vehicle Tire Safety Regulations — a
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Transport, pursuant to subsection 3(2), sections 4 and 5 b , subsection 7(1), section 10 and subsection 11(1) of the Motor Vehicle Safety Act a , makes the annexed Motor Vehicle Tire Safety Regulations . a S.C. 1993, c. 16 b S.C. 1999, c. 33, s. 351
Motor Vehicle Tire Safety Regulations — 1
Definitions 1 (1) The following definitions apply in these Regulations. Act means the Motor Vehicle Safety Act . ( Loi ) bead means the portion of a tire that is made of steel wires wrapped or reinforced by plies and that is shaped to fit the rim. ( talon ) bias ply tire means a tire in which the ply cords that extend to the beads are laid at alternate angles that are substantially less than 90° to the centreline of the tread. ( pneu à carcasse diagonale ) CMVSS means Canada Motor Vehicle Safety Standard. ( NSVAC ) FI tire means a tire designed for use only on farm implements that are occasionally driven or drawn on a road. ( pneu pour instruments aratoires ) load rating means the maximum load a tire is rated to carry at a given inflation pressure. ( charge nominale ) maximum load rating means the load rating of a tire at the maximum permissible inflation pressure for that tire. ( limite de charge nominale ) maximum permissible inflation pressure means the maximum cold inflation pressure to which a tire may be inflated. ( pression maximale permise de gonflage ) ply means a layer of rubber-coated parallel cords. ( pli ) radial ply tire means a tire in which the ply cords that extend to the beads are laid at substantially 90° to the centreline of the tread. ( pneu à carcasse radiale ) rim means a support for a tire or a tire-and-tube assembly on which the beads are seated. ( jante ) sidewall means the portion of a tire that is between the tread and the bead. ( flanc ) ST tire means a tire designed for use only on trailers drawn on a road. ( pneu à usage spécial ) tread means the portion of a tire that comes into contact with the road. ( bande de roulement ) TSD 109 means Technical Standards Document No. 109, New Tires and Certain Specialty Tires , as amended from time to time. ( DNT 109 ) TSD 119 means Technical Standards Document No. 119, New Tires for Motor Vehicles With a GVWR of More Than 4 536 kg and Motorcycles , as amended from time to time. ( DNT 119 ) TSD 139 means Technical Standards Document No. 139, New Radial Ply Tires for Motor Vehicles With a GVWR of 4 536 kg or Less , as amended from time to time. ( DNT 139 ) T-type temporary-use spare tire means a temporary-use spare tire that is designed for use at inflation pressures that are higher than those established for standard and reinforced tires. ( pneu de secours de type T à usage temporaire ) Terms defined in the MVSR (2) In these Regulations, GVWR , light-truck tire , motorcycle , passenger car , rim diameter and trailer have the same meaning as in subsection 2(1) of the Motor Vehicle Safety Regulations . Terms defined in TSD 109, 119 or 139 (3) For the purposes of these Regulations, words and expressions used in TSD 109, TSD 119 or TSD 139 and not defined in that technical standards document but defined in either of those other technical standards documents have the same meaning as in that other technical standards document. SOR/2014-307, s. 32
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
Act means the Motor Vehicle Safety Act . ( Loi )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
bead means the portion of a tire that is made of steel wires wrapped or reinforced by plies and that is shaped to fit the rim. ( talon )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
bias ply tire means a tire in which the ply cords that extend to the beads are laid at alternate angles that are substantially less than 90° to the centreline of the tread. ( pneu à carcasse diagonale )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
CMVSS means Canada Motor Vehicle Safety Standard. ( NSVAC )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
FI tire means a tire designed for use only on farm implements that are occasionally driven or drawn on a road. ( pneu pour instruments aratoires )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
load rating means the maximum load a tire is rated to carry at a given inflation pressure. ( charge nominale )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
maximum load rating means the load rating of a tire at the maximum permissible inflation pressure for that tire. ( limite de charge nominale )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
maximum permissible inflation pressure means the maximum cold inflation pressure to which a tire may be inflated. ( pression maximale permise de gonflage )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
ply means a layer of rubber-coated parallel cords. ( pli )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
radial ply tire means a tire in which the ply cords that extend to the beads are laid at substantially 90° to the centreline of the tread. ( pneu à carcasse radiale )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
rim means a support for a tire or a tire-and-tube assembly on which the beads are seated. ( jante )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
sidewall means the portion of a tire that is between the tread and the bead. ( flanc )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
ST tire means a tire designed for use only on trailers drawn on a road. ( pneu à usage spécial )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
tread means the portion of a tire that comes into contact with the road. ( bande de roulement )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
TSD 109 means Technical Standards Document No. 109, New Tires and Certain Specialty Tires , as amended from time to time. ( DNT 109 )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
TSD 119 means Technical Standards Document No. 119, New Tires for Motor Vehicles With a GVWR of More Than 4 536 kg and Motorcycles , as amended from time to time. ( DNT 119 )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
TSD 139 means Technical Standards Document No. 139, New Radial Ply Tires for Motor Vehicles With a GVWR of 4 536 kg or Less , as amended from time to time. ( DNT 139 )
Motor Vehicle Tire Safety Regulations — Motor Vehicle Tire Safety Regulations
T-type temporary-use spare tire means a temporary-use spare tire that is designed for use at inflation pressures that are higher than those established for standard and reinforced tires. ( pneu de secours de type T à usage temporaire )
Motor Vehicle Tire Safety Regulations — 2
System of measurement 2 If, in the application to a tire of a portion of a section of these Regulations or a portion of a provision of a technical standards document, either the metric or the imperial system of measurement is used, the same system of measurement must be used in the application to the tire of any other portion of the section or provision.