Comment is sought within three months on draft general medicine regulations with potentially significant implications for: labelling medicines intended for human use; making related professional information available; and ensuring that broader consumer information meets specific criteria.
While a maximum penalty of 10 years’ imprisonment is mooted as one of the penalties for non-compliance, at this stage no cap is placed on fines. Once in force, the new regulations will replace those in place since April 2003, notes Pam Saxby for Legalbrief Policy Watch.
Other issues addressed include: medicine prescription particulars; using Schedule 7 and 8 substances for treating individual patients; licences to manufacture, import, export and distribute scheduled substances; licences to compound and dispense medicines; registering medicines, medical devices and in vitro diagnostics; information to be included in the medicines register; conducting clinical trials; the sale of unregistered medicines for purposes other than clinical trials; inspection-related sampling, batch testing and seizure; advertising Schedule 1 substances; and requirements specific to veterinary medicines.
[link url="http://legalbrief.co.za/diary/legalbrief-today/policy-watch/legislation-new-general-medicine-regulations-mooted/#redirect"]Legalbrief report[/link]