Transitional Provisions (continued)
Marginal note: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.
Marginal note: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.
Marginal note:Distribution or importation — requirements
(2) Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made.
Marginal note: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.
Marginal note: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.
Marginal note: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.
(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.
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.
Consequential Amendment to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations
Coming into Force
Marginal note:Coming into force of section 10 of Act
Marginal note:180th day
Return to footnote *[Note: Regulations, except section 3, in force February 4, 2020, section 3 in force August 2, 2020, see SI/2019-37.]
- Date modified: