38CPowers of Secretary in relation to monitored medicines database

38C Powers of Secretary in relation to monitored medicines database

[Section 38C of Part III Inserted by No. 21 of 2021, s. 7, Applied:17 Dec 2021]

(1)  For the purposes of establishing and maintaining the monitored medicines database and furthering the purposes of the monitored medicines database, the Secretary may –

(a) authorise, in writing and with or without any conditions, as the Secretary considers necessary, a person or an entity to collect, access, store and otherwise deal with information, provided to the monitored medicines database, for the purpose of operating the database; and

(b) collect, access, store and otherwise deal with information, required for the monitored medicines database or permitted to be collected, accessed, stored or otherwise dealt with by or under this Act or the regulations; and

(c) authorise, in writing and with or without any conditions, as the Secretary considers necessary, a data source entity to provide information to the monitored medicines database in the prescribed manner and in the prescribed form; and

(d) require, in writing and with or without any conditions, as the Secretary considers necessary, a person or a class of persons to provide information to the monitored medicines database in the prescribed manner and in the prescribed form; and

(e) authorise, in writing and with or without any conditions, as the Secretary considers necessary, the manner, and the form, in which information in relation to the issue of prescriptions for the sale or supply of monitored medicines, the dispensing of any such prescription, and the sale or supply of any such monitored medicines thereunder, are to be provided to the monitored medicines database; and

(f) authorise, in writing and with or without any conditions, as the Secretary considers necessary, the manner, and the form, in which information in relation to the sale or supply of monitored medicines otherwise than on and in accordance with a prescription is to be provided to the monitored medicines database by a person who is authorised to do so by or under this Act; and

(g) collect, access, store and otherwise deal with information in the monitored medicines database for the purpose of ascertaining whether there is or has been a contravention of, or a failure to comply with, this Act; and