(1) Organizations wishing to operate blood transfusion services shall apply for a license to the Ministry by attaching the details and documents prescribed by the Ministry.
(2) The blood transfusion centers which are in operation at the time of commencement of this regulation shall apply for a license as per sub-rule (1) within three months of the commencement of this regulation.
(3) If the institution applying for a license according to sub-rule (1) or (2) is found to have fulfilled the criteria of operation according to rule 9 and rule 11, the ministry may grant a license to operate blood transfusion services.
(4) The duration of the license granted as per sub-rule (3) shall be three years. (5) In accordance with this rule, the licensing institution shall submit an application to the Ministry for renewal of the license at least three months before the expiry of the license period.
(6) After receiving the application according to sub-rule (5), the Ministry may renew the license of the institution operating such blood transfusion service after examining whether it is operating according to the standards or not.
(7) According to sub-rule (3), the licensed organization may set up blood transfusion units to operate blood transfusion services in the hospital.
(8) Organizations conducting blood transfusion services shall collect only safe blood.
(9) The Ministry will monitor and inspect whether the institution operating the blood transfusion service is operating the blood transfusion service according to the standards of the Act and this regulation.
(10) If any blood transfusion organization is not found to be operating the service according to the standards of the Act and this regulation through the monitoring and inspection as per sub-rule (9), the Ministry may make such organization comply with the standards within a certain period of time or revoke the license of the organization. But before revoking the license in that way, the organization should be given an opportunity to submit clarifications.