GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Safety of Sperm and Ova Regulations — 77
General 77 (1) An establishment and a health professional must keep records that contain all the documents and information required under these Regulations and all other records that demonstrate that they meet the requirements of these Regulations. Donor identification codes and donation codes (2) An establishment and a health professional must ensure that the donor identification code and the donation code are components of all of their records that relate to the processing, distribution, importation or making use of sperm or ova.
Safety of Sperm and Ova Regulations — 78
Retention period — general 78 (1) An establishment and a health professional must keep records for 10 years after their creation unless otherwise specified in these Regulations. Retention period — employees (2) An establishment must keep records containing records of the qualifications, training and competency of its employees for 10 years after the day on which an individual ceases to be an employee of the establishment. Retention period — standard operating procedures (3) An establishment must keep a copy of every version of its standard operating procedures for 10 years after the day on which they are superseded by a new version.
Safety of Sperm and Ova Regulations — 79
Processing 79 (1) A primary establishment must keep records that contain the following documents and information with respect to the sperm or ova it processes: (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova; (b) the number of immediate containers on which the same donation code appears; (c) the type of donation, whether sperm or ova; (d) the date of the donation; (e) any documents and information with respect to the suitability of the donor; (f) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; and (g) any information with respect to the disposition of the sperm or ova. Establishment to cooperate (2) An establishment that processes sperm or ova on behalf of a primary establishment must provide to the primary establishment all of the documents and information that it possesses to update the primary establishment’s records.
Safety of Sperm and Ova Regulations — 80
Distribution and importation 80 An establishment that distributes or imports sperm or ova and a health professional who distributes sperm to a recipient for their personal use must keep records that contain the following documents and information with respect to that sperm or those ova: (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova; (b) the number of immediate containers on which the same donation code appears; (c) the contact information for the establishment from which the establishment or health professional received the sperm or ova, if applicable; (d) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; (e) the contact information for each establishment, health professional or recipient to which the establishment or health professional distributes the sperm or ova, if applicable; and (f) any information with respect to the disposition of the sperm or ova.
Safety of Sperm and Ova Regulations — 81
Making use 81 (1) An establishment and a health professional must keep records that contain the following documents and information with respect to the sperm or ova of which it makes use: (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova; (b) the number of immediate containers on which the same donation code appears; (c) the contact information and registration number of the primary establishment that processed the sperm or ova; (d) if applicable, the contact information for the establishment from which the establishment or health professional received the sperm or ova, if they were not received from a primary establishment; (e) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; (f) any information that allows for the identification of the recipient; and (g) any information with respect to the disposition of the sperm or ova. Establishment to cooperate (2) An establishment must provide to the establishment and health professional all of the documents and information that it possesses to update the establishment and health professional’s records.
Safety of Sperm and Ova Regulations — 82
Retention period — processing, distribution, importation and making use 82 An establishment and a health professional must keep records in respect of each immediate container of sperm or ova for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm or ova.
Safety of Sperm and Ova Regulations — 83
Investigation 83 (1) An establishment or health professional that has conducted or received a notice of an investigation respecting an accident, error or adverse reaction must keep records that contain (a) any documents and information with respect to the investigation; (b) any notices that were received and copies of those that were sent and a list of all the establishments, health professionals or recipients to which they were sent; and (c) a copy of any reports sent to the Minister. Retention period (2) An establishment and a health professional must keep records for a period of 10 years after the date of the last recording in that record.
Safety of Sperm and Ova Regulations — 84
Record qualities 84 (1) Records containing documents and information must be complete and kept in a manner that allows them to be audited at any time. Information qualities (2) The information must be accurate, legible and indelible.
Safety of Sperm and Ova Regulations — 85
Storage of records 85 An establishment and a health professional must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.
Safety of Sperm and Ova Regulations — 86
Primary establishment not registered 86 (1) A primary establishment that, before the day on which these Regulations come into force, processes sperm or ova may, despite section 4 , continue to do so without having been registered, if it submits an application for registration under section 5 within 90 days after that day. Duration (2) Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made.
Safety of Sperm and Ova Regulations — 87
Registration number 87 Despite paragraphs 11 (2)(b), 18 (1)(f) and 50 (e), subparagraph 51 (1)(b)(v) and paragraph 81 (1)(c), a primary establishment’s registration number does not have to be provided before the 180th day after the day on which these Regulations come into force.
Safety of Sperm and Ova Regulations — 88
Distribution or importation before coming into force of these Regulations — notice 88 An establishment that, before the day on which these Regulations come into force, distributes or imports sperm or ova may continue to do so, despite section 18 , if it sends a notice to the Minister that meets the requirements of that section within 90 days after that day.
Safety of Sperm and Ova Regulations — 89
Distribution or importation — requirements 89 (1) An establishment that, on or before the day on which these Regulations come into force, distributes or imports sperm or ova must ensure that (a) the sperm or ova were processed in accordance with these Regulations by a primary establishment; and (b) the primary establishment has submitted an application for registration under section 5 within 90 days after the day on which these Regulations come into force. Duration (2) Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made.
Safety of Sperm and Ova Regulations — 90
Sperm obtained before these Regulations come into force 90 (1) This section applies to sperm that is obtained before the day on which these Regulations come into force and that may be distributed, imported and used — despite the requirements set out in sections 22 to 40 – only if (a) the sperm is processed, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations , in accordance with those Regulations; or (b) the sperm is the subject of a special access authorization under section 20 of those Regulations. Special access authorization (2) Despite subsection (1), sperm that is the subject of a special access authorization may only be distributed and used for the purpose for which the authorization is granted. Immediate container (3) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the identification code, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations , appears in a clear and indelible manner on the label of the immediate container. Documentation (4) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the immediate container of sperm is accompanied by documentation that contains the following information in English or French: (a) the donation code; (b) the name and business address of the processor within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations ; (c) the date of the donation, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results; and (d) a copy of the special access authorization, if any.
Safety of Sperm and Ova Regulations — 91
Records 91 An establishment and a health professional must keep records of all documents and information as required under the Processing and Distribution of Semen for Assisted Conception Regulations , in respect of each immediate container of sperm, unless otherwise required by these Regulations, for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm.
Safety of Sperm and Ova Regulations — 93
93 The Processing and Distribution of Semen for Assisted Conception Regulations 2 are repealed. 2 SOR/96-254
Safety of Sperm and Ova Regulations — Coming into force of section 10 of Act
Coming into force of section 10 of Act * 94 (1) Subject to subsection (2), these Regulations come into force on the day on which section 10 of the Assisted Human Reproduction Act comes into force. 180th day (2) Section 3 comes into force on the 180th day after the day on which section 10 of the Assisted Human Reproduction Act comes into force. * [Note: Regulations, except section 3, in force February 4, 2020, section 3 in force August 2, 2020, see SI/2019-37.]
Reimbursement Related to Assisted Human Reproduction Regulations — Reimbursement Related to Assisted Human Reproduction Regulations
Whereas, pursuant to subsection 66(1) of the Assisted Human Reproduction Act a , the Minister of Health has laid a copy of the proposed Reimbursement Related to Assisted Human Reproduction Regulations before each House of Parliament, substantially in the annexed form;
Reimbursement Related to Assisted Human Reproduction Regulations — Reimbursement Related to Assisted Human Reproduction Regulations
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 65(1) b of the Assisted Human Reproduction Act a , makes the annexed Reimbursement Related to Assisted Human Reproduction Regulations .
Reimbursement Related to Assisted Human Reproduction Regulations — 1
Definitions 1 The following definitions apply in these Regulations. Act means the Assisted Human Reproduction Act . ( Loi ) dependant means, in respect of a donor of sperm or ova or a surrogate mother, a person who resides with them and is dependent on them by reason of age or mental or physical incapacity. ( personne à charge )
Reimbursement Related to Assisted Human Reproduction Regulations — Reimbursement Related to Assisted Human Reproduction Regulations
Act means the Assisted Human Reproduction Act . ( Loi )
Reimbursement Related to Assisted Human Reproduction Regulations — Reimbursement Related to Assisted Human Reproduction Regulations
dependant means, in respect of a donor of sperm or ova or a surrogate mother, a person who resides with them and is dependent on them by reason of age or mental or physical incapacity. ( personne à charge )
Reimbursement Related to Assisted Human Reproduction Regulations — 2
Expenditures — donating sperm or ova 2 The following expenditures incurred by a donor in the course of donating sperm or ova may be reimbursed under subsection 12(1) of the Act: (a) travel expenditures, including expenditures for transportation, parking, meals and accommodation; (b) expenditures for the care of dependants or pets; (c) expenditures for counselling services; (d) expenditures for legal services and disbursements; (e) expenditures for obtaining any drug or device as defined in section 2 of the Food and Drugs Act ; (f) expenditures for obtaining products or services that are provided or recommended in writing by a person authorized under the laws of a province to practise medicine in that province; (g) expenditures for obtaining a written recommendation referred to in paragraph (f); (h) expenditures for health, disability, travel or life insurance coverage; and (i) expenditures for obtaining or confirming medical or other records.
Reimbursement Related to Assisted Human Reproduction Regulations — 3
Expenditures — maintenance and transport of in vitro embryo 3 The following expenditures incurred by any person may be reimbursed under subsection 12(1) of the Act: (a) expenditures for the maintenance of an in vitro embryo, including storage; and (b) expenditures for the transport of an in vitro embryo, including expenditures for preparing it for transport, for the shipping container and for preparing the container for transport.
Reimbursement Related to Assisted Human Reproduction Regulations — 4
Expenditures — surrogacy 4 The following expenditures incurred by a surrogate mother in relation to her surrogacy may be reimbursed under subsection 12(1) of the Act: (a) travel expenditures, including expenditures for transportation, parking, meals and accommodation; (b) expenditures for the care of dependants or pets; (c) expenditures for counselling services; (d) expenditures for legal services and disbursements; (e) expenditures for obtaining any drug or device as defined in section 2 of the Food and Drugs Act ; (f) expenditures for obtaining products or services that are provided or recommended in writing by a person authorized under the laws of a province to assess, monitor and provide health care to a woman during her pregnancy, delivery or the postpartum period; (g) expenditures for obtaining a written recommendation referred to in paragraph (f); (h) expenditures for the services of a midwife or doula; (i) expenditures for groceries, excluding non-food items; (j) expenditures for maternity clothes; (k) expenditures for telecommunications; (l) expenditures for prenatal exercise classes; (m) expenditures related to the delivery; (n) expenditures for health, disability, travel or life insurance coverage; and (o) expenditures for obtaining or confirming medical or other records.
Reimbursement Related to Assisted Human Reproduction Regulations — 5
Expenditures — use of an automobile 5 In the case of expenditures referred to in paragraphs 2 (a), 3 (b) and 4 (a), the maximum amount that may be reimbursed for the use of an automobile, other than an automobile used by a transportation service that provides a receipt, is the amount that is calculated on the basis of the distance driven in kilometres and the applicable automobile allowance rate posted on the Canada Revenue Agency’s website for the year in which the transport or transportation occurred.
Reimbursement Related to Assisted Human Reproduction Regulations — 6
Preliminary requirements for reimbursement 6 A person may only reimburse the applicable expenditure referred to in sections 2 to 4 to the person requesting reimbursement if they have obtained the following documents: (a) a declaration dated and signed by the person who requests the reimbursement that sets out (i) their name and address, (ii) the nature of each expenditure incurred, (iii) with respect to each expenditure, the amount incurred and, if less than the amount incurred, the amount requested for reimbursement, (iv) the date on which each expenditure was incurred, (v) in the case of a transport or transportation expenditure for the use of an automobile, other than an automobile used by a transportation service that provides a receipt, with respect to each trip, (A) the addresses of the points of departure and destination, and (B) the total distance in kilometres driven between those two points, (vi) a statement indicating that each expenditure was incurred in the course of donating sperm or ova, in the maintenance or transport of an in vitro embryo or in relation to a surrogacy, as applicable, (vii) a statement for each expenditure indicating that the amount has not been paid to them by any other source, in full or in part, and (viii) a statement confirming that all of the information contained in the declaration is accurate and complete to the best of their knowledge; (b) if applicable, a copy of the written recommendation of a person authorized under the laws of a province to practise medicine in that province and obtained in relation to a product or service for which a request for reimbursement has been made; (c) if applicable, a copy of the written recommendation of a person authorized under the laws of a province to assess, monitor and provide health care to a woman during her pregnancy, delivery or the postpartum period and obtained in relation to a product or service for which a request for reimbursement has been made; and (d) a receipt for each expenditure for which the reimbursement is requested that identifies the date on which the expenditure was incurred, except in the case of transport or transportation expenditures for the use of an automobile in accordance with section 5.
Reimbursement Related to Assisted Human Reproduction Regulations — 7
Reimbursement — sign and affirm 7 A person who reimburses an expenditure set out in a declaration must indicate on the declaration the amount of each expenditure that they reimbursed and the date of the reimbursement and must sign it to affirm that information.
Reimbursement Related to Assisted Human Reproduction Regulations — 8
Preliminary requirements for reimbursement 8 A person may only reimburse a surrogate mother for a loss of work-related income incurred during her pregnancy under subsection 12(3) of the Act if they have obtained the following documents: (a) a declaration dated and signed by the surrogate mother that sets out (i) her name and address, (ii) the start and end dates of the period during her pregnancy when she did not work for a reason certified by a qualified medical practitioner under paragraph 12(3)(a) of the Act, (iii) the amount requested for reimbursement, (iv) a statement indicating that she has not received compensation from any other source, in full or in part, for the loss of income, and (v) a statement indicating that all of the information submitted in the declaration is accurate and complete to the best of her knowledge; (b) supporting evidence of the income that she would have earned had she not been absent from work for the period specified in subparagraph (a)(ii); and (c) a copy of the certification provided by a qualified medical practitioner in paragraph 12(3)(a) of the Act.
Reimbursement Related to Assisted Human Reproduction Regulations — 9
Reimbursement — sign and affirm 9 A person who reimburses a surrogate mother for a loss of work-related income must indicate on the declaration the amount of the loss of income that they reimbursed and the date of the reimbursement, and must sign it to affirm that information.
Reimbursement Related to Assisted Human Reproduction Regulations — 10
Exemption regarding receipt 10 A person who reimburses transport or transportation expenditures is exempt from the application of subsection 12(2) of the Act if the expenditures were incurred for the use of an automobile, other than an automobile used by a transportation service that provides a receipt.
Reimbursement Related to Assisted Human Reproduction Regulations — 11
Maintain records — reimbursement for expenditures 11 (1) A person who reimburses expenditures referred to in these Regulations must, for each reimbursement, maintain a record of all documents obtained for the purposes of that reimbursement for a period of six years after the date of the reimbursement. Maintain records — reimbursement for loss of income (2) A person who reimburses a surrogate mother for a loss of work-related income incurred during her pregnancy must, for each reimbursement, maintain a record of all documents obtained for the purposes of that reimbursement for a period of six years after the date of the reimbursement.
Reimbursement Related to Assisted Human Reproduction Regulations — 12
Notice from Minister 12 (1) The Minister may, by written notice, require a person who must maintain a record in relation to a reimbursement under section 11 to provide to the Minister any record or additional information related to the reimbursement by the date specified in the notice. Obligation to provide records or information (2) Any person who has been notified under subsection (1) must provide to the Minister any required record or additional information related to the reimbursement by the date specified in the notice.
Reimbursement Related to Assisted Human Reproduction Regulations — Reimbursement Related to Assisted Human Reproduction Regulations
S.C. 2004, c. 2 * 13 These Regulations come into force on the day on which section 12 of the Assisted Human Reproduction Act , chapter 2 of the Statutes of Canada, 2004, comes into force. * [Note: Regulations in force June 9, 2020, see SI/2019-38.]
Administration and Enforcement (Assisted Human Reproduction Act) Regulations — Administration and Enforcement (Assisted Human Reproduction Act) Regulations
Whereas, pursuant to subsection 66(1) of the Assisted Human Reproduction Act a , the Minister of Health has laid a copy of the proposed Administration and Enforcement (Assisted Human Reproduction Act) Regulations before each House of Parliament, substantially in the annexed form;
Administration and Enforcement (Assisted Human Reproduction Act) Regulations — Administration and Enforcement (Assisted Human Reproduction Act) Regulations
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 65(1) b of the Assisted Human Reproduction Act a , makes the annexed Administration and Enforcement (Assisted Human Reproduction Act) Regulations .