Organon Laboratories Ltd v Department of Health and Social Security

(1990) 1 Med LR 417

COURT OF APPEAL

Lord Justice MUSTILL, Lord Justice RUSSELL, and Lord Justice STUART-SMITH

Medicine — Safety — Mianserin — Variation of licence — Evidence — Licence to sell medicinal product varied by licensing authority on advice of Committee on Safety of Medicines and Medicines Commission — Evidence of safety of medicine in overdose excluded — Whether Committee on Safety of Medicines misdirected itself — EEC directive 65 of 1965 in potential conflict with Medicines Act 1968 — Whether State precluded, as against individual, from relying on directive which it had not put into legislative effect. — European Community — Harmonization of laws — Medical products — EEC directive 65 of 1965 in potential conflict with Medicines Act 1968 — Whether State precluded, as against individual, from relying on directive which it had not put into legislative effect