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Introductory Text
PART 1 The Commissioner for Patient Safety
1.Establishment and core duties etc
PART 2 Human medicines
CHAPTER 1 Regulations
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 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
10.Power to make regulations about veterinary medicines
11.Manufacture, marketing, supply and field trials
12.Fees, offences, powers of inspectors, costs
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
1.Principles relating to core duties
2.Involvement of patients
3.Supplementary functions and information
4.Individual cases
5.Amendments to primary legislation
6.Regulations about appointment and operation
SCHEDULE 2
Medical devices: civil sanctions
PART 1 Monetary penalties
1.Imposition of monetary penalty
2.Notices, representations and appeals etc
3.Information to be included in notices under paragraph 2
4.Monetary penalties: criminal proceedings and conviction
PART 2 Enforcement undertakings
5.(1) This paragraph applies where— (a) the Secretary of State...
PART 3 Enforcement costs recovery notices
6.Imposition of enforcement costs recovery notices
7.Information to be included in enforcement costs recovery notices
8.Appeals
PART 4 Power to make supplementary provision etc by regulations
9.Supplementary regulations: general
10.Monetary penalties and costs
11.Enforcement undertakings
12.Appeals
PART 5 General and supplemental
13.Guidance as to enforcement
14.Pre-commencement consultation
15.Reports on use of civil sanctions
16.Disclosure of information
PART 6 Interpretation
17.In this Schedule— “enforcement costs recovery notice” has the meaning...
SCHEDULE 3
Offence of breaching provisions in the Medical Devices Regulations 2002
PART 1 Offence
1.In the Medical Devices Regulations 2002 (S.I. 2002/618), after regulation...
PART 2 Provisions
2.In the Medical Devices Regulations 2002 (S.I. 2002/618), after the...