BoMRA DraftDraft statutory instrument (no number assigned)
Draft statutory instrument (no number assigned) is the official BoMRA identifier for “Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 (draft)”. Draft statutory instrument (no number assigned) is the official identifier BoMRA uses for this instrument.
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Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 (draft)
The companion draft to the 2026 device regulations: the fee, levy and penalty schedule that would replace the 2019 fee regulations. Forty-seven regulations in ten Parts (regulation 45 the risk-based penalty framework, 46 transitional, 47 repeal), made under the Medicines and Related Substances Act, 2025, with seven Schedules carrying the actual tariffs (product registration, licensing, permits and services, inspections, levies, penalties, and clinical-trial fees keyed to study phase). It is an UNMADE DRAFT: the copy reads "STATUTORY INSTRUMENT NO. ___ OF 2026" and "(Published on _______________, 2026)", both blank, and regulation 1(2) defers commencement to a ministerial Order. Ingested as a draft, not as law.
Draft statutory instrument (no number assigned) is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.