Retained EU Law SI 2017/1569 United Kingdom

Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)

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.

Manufacturer12

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.

s.art003 Conformity with good manufacturing practice Regulated
  • Follow GMP and hold authorisation for investigational medicinal productsManufacturer
s.art004 Compliance with clinical trial authorisation Regulated
  • Ensure manufacturing complies with clinical trial authorisation and keep methods up to dateManufacturer
s.art005 Pharmaceutical quality system Regulated
  • Set up a pharmaceutical quality system for investigational medicinesManufacturer
s.art006 Personnel Regulated
  • Ensure competent staff, defined roles, training and hygiene for IMP manufacturingManufacturer
s.art007 Premises and equipment Regulated
  • Design, maintain and validate premises and equipment for investigational medicinal productsManufacturer
s.art008 Documentation Regulated
  • Set up and maintain a full documentation system for manufacturingManufacturer
s.art009 Production Regulated
  • Control production, validate processes and prevent contaminationManufacturer
s.art010 Quality control Regulated
  • Set up and maintain a quality control system for investigational medicinal productsManufacturer
s.art011 Retention of samples used for quality control Regulated
  • Retain samples of investigational medicinal products and starting materials for at least two yearsManufacturer
s.art014 Complaints, product recall and emergency unblinding Regulated
  • Set up systems for complaints, recalls and emergency unblindingManufacturer
s.art015 Self-inspection by the manufacturer Regulated
  • Carry out regular self-inspections and take corrective actionManufacturer
s.art024 Access to premises Regulated
  • Allow inspectors access to premises and documentation at all timesManufacturer
15 other provisions — procedural and definitional
s.art001 Subject matter
s.art002 Definitions
s.art012 Responsibilities of the qualified person
s.art013 Outsourced operations
s.art016 Advanced therapy investigational medicinal products
s.art017 Supervision by inspection
s.art018 Cooperation and coordination of inspections
s.art019 Recognition of inspection conclusions
s.art020 Empowerments of the inspectors
s.art021 Competence and obligations of the inspectors
s.art022 Quality system
s.art023 Impartiality of inspectors
s.art025 Suspension or revocation of manufacturing authorisation
s.art026 Transitional provision
s.art027 Entry into force

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