Statutory Instruments

Medicinal Products (Licensing and Sale) Regulations, 1998

These regulations replace the Medical Preparations (Licensing and Sale) Regulations, 1996. The Regulations provide for a licensing scheme for medicinal products for human use and related matters as required by Council Directives 65/65/EEC of 26 January 1965, (O.J. No. 22 of 9.2.65), 75/318/EEC (O.J. No. L147 of 9.6.75) and 75/319/EEC (O.J. No. L147 of 9.6.75) as amended, and, in so far as homoeopathic medicines are concerned, Council Directive 92/72/EEC of 22 September 1992 (O.J. No. L297 of 13.10.92)

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