Medicines and Medical Devices Bill (HL Bill 163)

Contents

1. Part 1

   The Commissioner for Patient Safety

   1. 1.Establishment and core duties etc

2. Part 2

   Human medicines

   1. Regulations

      1. 2.Power to make regulations about human medicines

      2. 3.Manufacture, marketing and supply

      3. 4.Falsified medicines

      4. 5.Clinical trials

      5. 6.Fees, offences, powers of inspectors

      6. 7.Emergencies

   2. International agreements: disclosure of information

      1. 8.Disclosure of information in accordance with international agreements

      2. 9.Requirement for draft consolidated legislation: human medicines

   3. Interpretation

      1. 10.Interpretation of Part 2

3. Part 3

   Veterinary medicines

   1. Regulations

      2. 11.Power to make regulations about veterinary medicines

      3. 12.Manufacture, marketing, supply and field trials

      4. 13.Fees, offences, powers of inspectors, costs

   2. International agreements: disclosure of information

      1. 14.Disclosure of information in accordance with international agreements

      2. 15.Requirement for draft consolidated legislation: veterinary medicines

   3. Interpretation etc

      1. 16.Interpretation of Part 3 and supplementary provision

4. Part 4

   Medical devices

   1. Regulations: general

      1. 17.Power to make regulations about medical devices

      2. 18.Manufacture, marketing and supply

      3. 19.Fees, information, offences

      4. 20.Emergencies

   2. Regulations: information systems, advisory committee

      1. 21.Information systems

      2. 22.Advisory committee

   3. Enforcement

      1. Enforcement notices

         1. 23.Compliance notices

         2. 24.Suspension notices

         3. 25.Safety notices

         4. 26.Information notices

         5. 27.Applications to set notices aside etc

         6. 28.Compensation

         7. 29.Further appeals

      2. Offences

         1. 30.Offences

         2. 31.Defence of due diligence

         3. 32.Offences by bodies corporate

      3. Civil sanctions

         1. 33.Civil sanctions

      4. Forfeiture

         1. 34.Forfeiture of medical devices

         2. 35.Appeals against forfeiture decisions

      5. Recovery of expenses of enforcement

         1. 36.Recovery of expenses of enforcement

      6. Recall of medical device by enforcement authority

         1. 37.Recall of medical device by enforcement authority

      7. Power of officer of Revenue and Customs to detain medical device

         1. 38.Power of officer of Revenue and Customs to detain medical device

         2. 39.Offence of obstructing an officer of Revenue and Customs

      8. Civil proceedings

         1. 40.Civil proceedings

   4. Disclosure of information and consequential etc provision

      1. Disclosure of information

         1. 41.Disclosure of information

         2. 42.Offences relating to information

      2. Consequential etc provision

         1. 43.Consequential and supplementary provision

         2. 44.Requirement for draft consolidated legislation: medical devices

   5. Interpretation of Part 4

      1. 45.Interpretation of Part 4

5. Part 5

   Regulations under Parts 1, 2, 3 and 4

   1. 46.Power to make consequential etc provision

   2. 47.Scope of powers of Northern Ireland departments

   3. 48.Consultation

   4. 49.Reporting requirements

   5. 50.Procedure

   6. 51.Super-affirmative procedure

   7. 52.Super-affirmative procedure: Northern Ireland

6. Part 6

   Extent, commencement and short title

   1. 53.Extent

   2. 54.Commencement

   3. 55.Transitional etc provision in connection with commencement

   4. 56.Short title

7. 1. Schedule 1

      Further provision about the Commissioner for Patient Safety

   2. Schedule 2

      Medical devices: civil sanctions

      1. Part 1

         Monetary penalties

      2. Part 2

         Enforcement undertakings

      3. Part 3

         Enforcement costs recovery notices

      4. Part 4

         Power to make supplementary provision etc by regulations

      5. Part 5

         General and supplemental

      6. Part 6

         Interpretation

   3. Schedule 3

      Offence of breaching provisions in the Medical Devices Regulations 2002

      1. Part 1

         Offence

      2. Part 2

         Provisions