UK Statutory Instrument 1977 United Kingdom

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

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At a glance

What's here

8 compliance obligations

What this Act requires

Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

sch. para. 1

sch. para. 1

  • Provide and maintain adequate staff, premises and plant for licensed manufacturing
sch. para. 2

sch. para. 2

  • Maintain adequate staff and facilities to avoid medicine deterioration
sch. para. 3

sch. para. 3

  • Manufacture medicinal products to licensed standards
sch. para. 4

sch. para. 4

  • House and manage animals used in production to comply with licence conditions
sch. para. 5

sch. para. 5

  • Arrange adequate testing of your medicines' strength, quality and purity
sch. para. 6

sch. para. 6

  • Notify licence holder of material changes to premises, plant or key personnel
sch. para. 7

sch. para. 7

  • Keep batch records for 5 years and allow MHRA inspection
sch. para. 8

sch. para. 8

  • Inform licence-holder of any material changes to manufacturing facilities or operations
Browse 11 other sections — procedural / definitional / commencement
s.001

Citation and commencement

s.002

Interpretation

s.003

Prescribed conditions for manufacturer's undertakings

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