UK Statutory Instrument SI 1977/1038 United Kingdom

The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer8

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

sch. para. 1 The manufacturer shall provide and maintain such staff, premises, and... Regulated
  • Provide and maintain adequate staff, premises and plant for licensed manufacturingManufacturer
sch. para. 2 The manufacturer shall provide and maintain such staff, premises, equipment... Regulated
  • Maintain adequate staff and facilities to avoid medicine deteriorationManufacturer
sch. para. 3 The manufacturer shall conduct all manufacture and assembly operations in... Regulated
  • Manufacture medicinal products to licensed standardsManufacturer
sch. para. 4 Where animals are used in the production of any medicinal... Regulated
  • House and manage animals used in production to comply with licence conditionsManufacturer
sch. para. 5 The manufacturer shall make such adequate and suitable arrangements as... Regulated
  • Arrange adequate testing of your medicines' strength, quality and purityManufacturer
sch. para. 6 The manufacturer shall inform the holder of the relevant product... Regulated
  • Notify licence holder of material changes to premises, plant or key personnelManufacturer
sch. para. 7 The manufacturer shall keep readily available for inspection by a... Regulated
  • Keep batch records for 5 years and allow MHRA inspectionManufacturer
sch. para. 8 The manufacturer shall inform the holder of the relevant product... Regulated
  • Inform licence-holder of any material changes to manufacturing facilities or operationsManufacturer
3 other provisions — procedural and definitional
s.001 Citation and commencement
s.002 Interpretation
s.003 Prescribed conditions for manufacturer's undertakings

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.