Vol. 407 No. 6
168 Mr. J. Higgins asked the Minister for Health if his attention has been drawn to the fact that in 1989, the statutory regulations regarding the labelling of drugs were not being followed in relation to an estimated 500 drug products; the measures taken by him to correct and monitor this situation; and the number of prosecutions taken for breach of labelling regulations.
The statutory regulations regarding the labelling of medicinal products are set out in the Medical Preparations (Advertisement and Sale) Regulations, 1958, as amended by the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. Furthermore when a manufacturer submits an application for a product authorisation, details of the labelling must accompany the application.
I am not aware of, nor has my attention been drawn to, the allegation that an estimated 500 drug products failed to comply with the statutory labelling requirements as set out in these regulations and no prosecutions for such breaches have been made.
The Deputy may be referring to the range of medicinal products referred to in the second schedule to the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989. These products are now subject to the controls stipulated in the principle regulations, including the labelling requirements.
