Medicines and Medical Devices Act 2021
Medicines and Medical Devices Act 2021 (2021 c. 3)
- Medicines and Medical Devices Act 2021 (2021 c. 3)
- PART 1 The Commissioner for Patient Safety
- 1 Establishment and core duties etc
- PART 2 Human medicines
- CHAPTER 1 Regulations: general
- 2 Power to make regulations about human medicines
- 3 Manufacture, marketing and supply
- 4 Falsified medicines
- 5 Clinical trials
- 6 Fees, offences, powers of inspectors
- 7 Emergencies
- CHAPTER 1A Regulations: information systems
- 7A Information systems
- 7B Offence of disclosing information
- CHAPTER 2 International agreements: disclosure of information
- 8 Disclosure of information in accordance with international agreements
- CHAPTER 3 Interpretation
- 9 Interpretation of Part 2
- PART 3 Veterinary medicines
- CHAPTER 1 Regulations
- 10 Power to make regulations about veterinary medicines
- 11 Manufacture, marketing, supply and field trials
- 12 Fees, offences, powers of inspectors, costs
- CHAPTER 2 International agreements: disclosure of information
- 13 Disclosure of information in accordance with international agreements
- CHAPTER 3 Interpretation etc
- 14 Interpretation of Part 3 and supplementary provision
- PART 4 Medical devices
- CHAPTER 1 Regulations: general
- 15 Power to make regulations about medical devices
- 16 Manufacture, marketing and supply
- 17 Fees, information, offences
- 18 Emergencies
- CHAPTER 2 Regulations: information systems, advisory committee
- 19 Information systems
- 20 Advisory committee
- CHAPTER 3 Enforcement
- Enforcement notices
- 21 Compliance notices
- 22 Suspension notices
- 23 Safety notices
- 24 Information notices
- 25 Applications to set notices aside etc
- 26 Compensation
- 27 Further appeals
- Offences
- 28 Offences
- 29 Defence of due diligence
- 30 Offences by bodies corporate
- Civil sanctions
- 31 Civil sanctions
- Forfeiture
- 32 Forfeiture of medical devices
- 33 Appeals against forfeiture decisions
- Recovery of expenses of enforcement
- 34 Recovery of expenses of enforcement
- Recall of medical device by enforcement authority
- 35 Recall of medical device by enforcement authority
- Power of officer of Revenue and Customs to detain medical device
- 36 Power of officer of Revenue and Customs to detain medical device
- 37 Offence of obstructing an officer of Revenue and Customs
- Civil proceedings
- 38 Civil proceedings
- CHAPTER 4 Disclosure of information and consequential etc provision
- Disclosure of information
- 39 Disclosure of information
- 40 Offences relating to information
- Consequential etc provision
- 41 Consequential and supplementary provision
- CHAPTER 5 Interpretation of Part 4
- 42 Interpretation of Part 4
- PART 5 Regulations under Parts 1, 2, 3 and 4
- 43 Power to make consequential etc provision
- 44 Scope of powers of Northern Ireland departments
- 45 Consultation
- 46 Reporting requirements
- 47 Procedure
- PART 6 Report on operation of medicines and medical devices legislation
- 48 Report on operation of medicines and medical devices legislation
- PART 7 Extent, commencement and short title
- 49 Extent
- 50 Commencement
- 51 Transitional etc provision in connection with commencement
- 52 Short title
- SCHEDULES
- SCHEDULE 1 Further provision about the Commissioner for Patient Safety
- Principles relating to core duties
- Involvement of patients
- Supplementary functions and information
- Individual cases
- Amendments to primary legislation
- Regulations about appointment and operation
- SCHEDULE 2 Medical devices: civil sanctions
- PART 1 Monetary penalties
- Imposition of monetary penalty
- Notices, representations and appeals etc
- Information to be included in notices under paragraph 2
- Monetary penalties: criminal proceedings and conviction
- PART 2 Enforcement undertakings
- PART 3 Enforcement costs recovery notices
- Imposition of enforcement costs recovery notices
- Information to be included in enforcement costs recovery notices
- Appeals
- PART 4 Power to make supplementary provision etc by regulations
- Supplementary regulations: general
- Monetary penalties and costs
- Enforcement undertakings
- Appeals
- PART 5 General and supplemental
- Guidance as to enforcement
- Pre-commencement consultation
- Reports on use of civil sanctions
- Disclosure of information
- PART 6 Interpretation
- SCHEDULE 3 Offence of breaching provisions in the Medical Devices Regulations 2002
- PART 1 Offence
- PART 2 Provisions