73 (1) An establishment that collects allogeneic blood must, before distributing it for transfusion or for use in the manufacture of a drug for human use, determine that it is safe for distribution once the establishment is satisfied that the blood has been processed in accordance with these Regulations.
(2) An establishment that collects autologous blood must, before distributing it for transfusion, determine that it is safe for autologous transfusion once the establishment is satisfied that the blood has been processed in accordance with these Regulations.
31 (1) An establishment must file with the Minister an application for registration in the form established by the Minister that contains all of the following information:
[...]
(b) in the case of an establishment that previously conducted its activities under these Regulations under another name, that other name;
(j) a statement, dated and signed by a senior executive officer, that certifies both of the following:
(i) that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations, and
28 (1) Subject to subsections (2) and (3), the Minister must reinstate an establishment licence if the establishment provides the Minister with sufficient evidence to demonstrate that it is in compliance with these Regulations.
(2) The Minister may refuse to reinstate an establishment’s licence if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations.
27 (1) The Minister may suspend all or part of an establishment licence in any of the following circumstances:
(b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request; or
(c) the establishment is not in compliance with these Regulations.
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.
