Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed.”
Proposed amendments
254 amendments across 34 provisions
Clause 1 33
Tabled againstAs introduced· Clause 1
Amendment text
Insert the following new Clause—
“PART A1
“PART A1
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed.”
Amendment text
at end insert—
In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—
In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
at end insert—
The power under subsection (1) may not be exercised to—
The power under subsection (1) may not be exercised to—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out subsection (2) and insert—
In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”
In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”
Amendment text
at end insert—
In making regulations under subsection (1), the appropriate authority must have the objective of safeguarding public health by promoting the availability and supply of human medicines.”
In making regulations under subsection (1), the appropriate authority must have the objective of safeguarding public health by promoting the availability and supply of human medicines.”
Amendment text
Leave out “public health” and insert “the health and safety of the public”
Amendment text
at end insert—
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Amendment text
leave out “making regulations under subsection (1)” and insert “considering whether they would”
Amendment text
at end insert—
the protection of the environment;”
the protection of the environment;”
Amendment text
leave out “have regard to” and insert “act with a view to ensuring”
Amendment text
leave out “an attractive or” and insert “a”
Amendment text
at end insert “, and, in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,”
Amendment text
leave out “conduct clinical trials or supply human medicines” and insert “—
carry out research relating to human medicines,
carry out research relating to human medicines,
Amendment text
at end insert “the safety of human medicines as the overriding consideration.”
Amendment text
at end insert—
the importance of prioritising the protection of human rights including citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
the importance of prioritising the protection of human rights including citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
Amendment text
at end insert—
Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”
Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”
Amendment text
leave out paragraph (a) and insert—
In making regulations under subsection (1), the appropriate authority must also have regard to the following as secondary considerations—”
In making regulations under subsection (1), the appropriate authority must also have regard to the following as secondary considerations—”
Amendment text
at end insert—
Before making regulations under subsection (1) that may have an impact on the safety of human medicines, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Before making regulations under subsection (1) that may have an impact on the safety of human medicines, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Amendment text
at beginning insert “the priority of ensuring”
Amendment text
leave out paragraph (c) and insert—
the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”
the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”
Amendment text
leave out paragraph (c) and insert—
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture human medicines”
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture human medicines”
Amendment text
after “trials” insert “, promote medical innovation”
Amendment text
at end insert—
the effect of the regulations on the ability of the National Health Service to meet the needs of patients;
the effect of the regulations on the ability of the National Health Service to meet the needs of patients;
Amendment text
at end insert—
the environmental and social impact of such medicines, including their manufacturing.”
the environmental and social impact of such medicines, including their manufacturing.”
Amendment text
at end insert—
citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
Amendment text
at end insert—
In subsection (2), “attractiveness” means—
In subsection (2), “attractiveness” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
In subsection (2)(c), “attractiveness” means the quality of being—
In subsection (2)(c), “attractiveness” means the quality of being—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
In subsection (2)(c), “attractiveness” means favourability for—
In subsection (2)(c), “attractiveness” means favourability for—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Clause 2 8
Amendment text
at end insert “, or
the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”
the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”
Amendment text
leave out paragraph (c)
Amendment text
at end insert—
the origin and treatment of human tissue used in the process of developing and manufacturing medicines.”
the origin and treatment of human tissue used in the process of developing and manufacturing medicines.”
Amendment text
at end insert—
the disposal of unused or waste medicines and the impact of medicines, or their derivates, entering the environment.”
the disposal of unused or waste medicines and the impact of medicines, or their derivates, entering the environment.”
Amendment text
at end insert—
developing rapid provisional two-year licences.”
developing rapid provisional two-year licences.”
Amendment text
at end insert—
Regulations under section 1(1) must make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay for the United Kingdom to get early access to new medicines.”
Regulations under section 1(1) must make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay for the United Kingdom to get early access to new medicines.”
Amendment text
Insert the following new Clause—
“Innovative Medicines Fund
“Innovative Medicines Fund
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Hub and spoke framework
“Hub and spoke framework
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 3 5
Amendment text
leave out “for any purpose to do with human medicines” and insert “for the purpose of ensuring patient safety”
Amendment text
leave out “, for any purpose to do with human medicines,”
Amendment text
at end insert “subject to subsection (1A)”
Amendment text
at end insert—
Within 6 months of this Act coming into force, the Secretary of State must—
Within 6 months of this Act coming into force, the Secretary of State must—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out “have regard to the importance of” and insert “act with a view to”
Clause 4 8
Amendment text
leave out “may” and insert “must”
Amendment text
leave out “or similar”
Amendment text
after “similar” insert “, where possible,”
Amendment text
at end insert “including the revised definitions of “clinical trial” and “co-sponsorship””
Amendment text
at end insert—
to support the involvement of the United Kingdom in EU-wide clinical trials.”
to support the involvement of the United Kingdom in EU-wide clinical trials.”
Amendment text
at end insert—
to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases.”
to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases.”
Amendment text
at end insert—
about requirements to consider babies, children and young people in research about new medicines, in a manner similar to the EU Paediatric Regulation.”
about requirements to consider babies, children and young people in research about new medicines, in a manner similar to the EU Paediatric Regulation.”
Amendment text
at end insert—
Regulations must be made under section 1(1) to require reporting on antimicrobial resistance in the microbiota of subjects during receipt of the drug in clinical trials and during the follow-up period.”
Regulations must be made under section 1(1) to require reporting on antimicrobial resistance in the microbiota of subjects during receipt of the drug in clinical trials and during the follow-up period.”
Clause 5 4
Amendment text
leave out paragraph (b)
Amendment text
leave out from “regulations,” to “or” in line 36
Amendment text
at end insert—
Regulations under section 1(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”
Regulations under section 1(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”
Amendment text
at end insert—
The Secretary of State must publish a fees regime in relation to subsection (1)(a) within three months of the date on which this Act is passed.”
The Secretary of State must publish a fees regime in relation to subsection (1)(a) within three months of the date on which this Act is passed.”
Clause 6 7
Amendment text
Insert the following new Clause—
“Entitlement of a doctor to prescribe medicinal cannabis products
“Entitlement of a doctor to prescribe medicinal cannabis products
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Strategy for tackling vaccination disinformation
“Strategy for tackling vaccination disinformation
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
leave out paragraph (b)
Amendment text
leave out subsection (3)
Amendment text
Insert the following new Clause—
“Disclosure of information in accordance with international agreements
“Disclosure of information in accordance with international agreements
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Extending prescribing rights
“Extending prescribing rights
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Requirement for consolidated legislation: human medicines
“Requirement for consolidated legislation: human medicines
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 7 10
Amendment text
after “a” insert “relevant”
Amendment text
at end insert—
Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—
Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”
Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”
Amendment text
After the first “the” insert “informed”
Amendment text
at end insert—
In this section, “consent” means that an individual has given notice of their willingness for an appropriate authority to disclose patient information relating them.”
In this section, “consent” means that an individual has given notice of their willingness for an appropriate authority to disclose patient information relating them.”
Amendment text
at end insert—
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
Amendment text
at end insert—
““patient information” means information (however recorded) which—
““patient information” means information (however recorded) which—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
In paragraph (b), leave out “enables” and insert “could enable”
Amendment text
at end insert—
““relevant person” means—
““relevant person” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Requirement for draft consolidated legislation: human medicines
“Requirement for draft consolidated legislation: human medicines
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 8 11
Amendment text
at end insert—
The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—
The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
The power under subsection (1) may not be exercised to—
The power under subsection (1) may not be exercised to—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out “making regulations under subsection (1)” and insert “considering whether they would”
Amendment text
leave out “have regard to” and insert “act with a view to ensuring”
Amendment text
leave out “in relation to animals, humans and the environment”
Amendment text
leave out paragraph (c) and insert—
the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to develop or supply veterinary medicines.”
the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to develop or supply veterinary medicines.”
Amendment text
leave out paragraph (c) and insert—
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture veterinary medicines.”
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture veterinary medicines.”
Amendment text
at end insert—
the welfare of animals which will be treated by veterinary medicines.”
the welfare of animals which will be treated by veterinary medicines.”
Amendment text
at end insert—
In subsection (2), “attractiveness” means—
In subsection (2), “attractiveness” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
In subsection (2)(c), “attractiveness” means the quality of being—
In subsection (2)(c), “attractiveness” means the quality of being—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Clause 9 9
Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed.”
Amendment text
at end insert—
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out from beginning to “promote” on line 23 and insert “In making regulations under subsection (1), the appropriate authority’s overarching objective must be to”
Amendment text
leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Amendment text
leave out “an attractive or” and insert “a”
Amendment text
leave out “develop or supply veterinary medicines” and insert “—
develop veterinary medicines, or
develop veterinary medicines, or
Amendment text
at end insert—
Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”
Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”
Amendment text
at end insert—
Before making regulations under subsection (1) that may have an impact on the safety of veterinary medicines, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Before making regulations under subsection (1) that may have an impact on the safety of veterinary medicines, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Amendment text
at end insert—
The Secretary of State must by regulations make provision about the use of the Cascade.”
The Secretary of State must by regulations make provision about the use of the Cascade.”
Clause 10 5
Amendment text
leave out paragraph (b)
Amendment text
leave out from “regulations,” to end of line 28
Amendment text
at end insert—
Regulations under section 8(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”
Regulations under section 8(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”
Amendment text
Insert the following new Clause—
“Disclosure of information in accordance with international agreements
“Disclosure of information in accordance with international agreements
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Requirement for consolidated legislation: veterinary medicines
“Requirement for consolidated legislation: veterinary medicines
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 11 2
Amendment text
Insert the following new Clause—
“Review of the impact of this Act on veterinary medicines
“Review of the impact of this Act on veterinary medicines
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Veterinary devices
“Veterinary devices
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 12 21
Amendment text
after “a” insert “relevant”
Amendment text
at end insert—
Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—
Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
Amendment text
at end insert—
““relevant person” means—
““relevant person” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Requirement for draft consolidated legislation: veterinary medicines
“Requirement for draft consolidated legislation: veterinary medicines
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Amendment text
at end insert—
The power under subsection (1) may not be exercised to—
The power under subsection (1) may not be exercised to—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
In making regulations under subsection (1), the Secretary of State must have the objective to safeguard public health through the supply of medical devices.”
In making regulations under subsection (1), the Secretary of State must have the objective to safeguard public health through the supply of medical devices.”
Amendment text
at end insert—
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out “making regulations under subsection (1)” and insert “considering whether they would”
Amendment text
leave out “have regard to” and insert “act with a view to ensuring”
Amendment text
at end insert “the safety of medical devices as the overriding consideration.”
Amendment text
leave out line 25 and insert—
In making regulations under subsection (1), the appropriate authority must also have regard to the following as secondary considerations—”
In making regulations under subsection (1), the appropriate authority must also have regard to the following as secondary considerations—”
Amendment text
at end insert “including in therapeutic practice”
Amendment text
leave out paragraph (c) and insert—
the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”
the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”
Amendment text
leave out paragraph (c) and insert—
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture medical devices.”
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture medical devices.”
Amendment text
at end insert—
the effect of the regulations on the ability of the National Health Service to meet the needs of patients;
the effect of the regulations on the ability of the National Health Service to meet the needs of patients;
Amendment text
at end insert—
the environmental and social impact of medical devices.”
the environmental and social impact of medical devices.”
Amendment text
at end insert—
In subsection (2), “attractiveness” means—
In subsection (2), “attractiveness” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
In subsection (2), “attractiveness” means the quality of being—
In subsection (2), “attractiveness” means the quality of being—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”
Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”
Clause 13 8
Amendment text
at end insert—
requirements about notification and reporting requirements in relation to clinical investigations undertaken to assess the safety or performance of a device,”
requirements about notification and reporting requirements in relation to clinical investigations undertaken to assess the safety or performance of a device,”
Amendment text
at end insert—
requirements that, in accordance with any recommendation of the National Institute for Health and Care Excellence, the National Health Service should make a medical device available for use within a specified period,”
requirements that, in accordance with any recommendation of the National Institute for Health and Care Excellence, the National Health Service should make a medical device available for use within a specified period,”
Amendment text
after “and” insert “unique device identification,”
Amendment text
leave out from first “to” to end of line 18 and insert “the use of medical devices in individual procedures to be tracked and entered in a register, or within hospital episode statistics data, and”
Amendment text
at end insert—
notification and reporting requirements for medical device clinical investigations.”
notification and reporting requirements for medical device clinical investigations.”
Amendment text
at end insert—
The provision mentioned in subsection (1)(b) may include provision for the development of a rapid provisional 2-year licensing procedure.”
The provision mentioned in subsection (1)(b) may include provision for the development of a rapid provisional 2-year licensing procedure.”
Amendment text
at end insert—
Regulations must be made under section 12(1) to require re-usable medical devices to be designed to facilitate decontamination, and manufacturers of re-usable medical devices to provide advice on the decontamination of their products in line with standard decontamination practice.”
Regulations must be made under section 12(1) to require re-usable medical devices to be designed to facilitate decontamination, and manufacturers of re-usable medical devices to provide advice on the decontamination of their products in line with standard decontamination practice.”
Amendment text
Insert the following new Clause—
“Innovative Medical Devices Fund
“Innovative Medical Devices Fund
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 14 10
Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed”
Amendment text
at end insert—
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out subsection (2) and insert—
In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”
In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”
Amendment text
leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Amendment text
leave out “an attractive or” and insert “a”
Amendment text
leave out “develop or supply medical devices” and insert “—
carry out research relating to medical devices,
carry out research relating to medical devices,
Amendment text
leave out “or” and insert “and”
Amendment text
at end insert—
Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.”
Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.”
Amendment text
at end insert—
Before making regulations under subsection (1) that may have an impact on the safety of medical devices, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Before making regulations under subsection (1) that may have an impact on the safety of medical devices, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Amendment text
leave out paragraph (d)
Clause 15 3
Amendment text
leave out paragraph (b)
Amendment text
leave out subsection (3)
Amendment text
Insert the following new Clause—
“Requirement to make regulations concerning medicinal cannabis and associated devices
“Requirement to make regulations concerning medicinal cannabis and associated devices
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 16 14
Amendment text
leave out “may” and insert “must”
Amendment text
after “of” insert “all”
Amendment text
at end insert—
provisional licences granted for new devices before they are placed on the market to inform the decision whether to grant final marketing authorisation under a full licence.”
provisional licences granted for new devices before they are placed on the market to inform the decision whether to grant final marketing authorisation under a full licence.”
Amendment text
at end insert—
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
leave out “may” and insert “must”
Amendment text
at end insert—
requiring that, subject to patient consent, information about any medical device implanted in the human body is entered and retained in an information system established under subsection (1);
requiring that, subject to patient consent, information about any medical device implanted in the human body is entered and retained in an information system established under subsection (1);
Amendment text
at end insert—
establishing a mechanism for patients to enter reports of their experience following the use of any medical device in their treatment, to be retained in any relevant information system established under subsection (1).”
establishing a mechanism for patients to enter reports of their experience following the use of any medical device in their treatment, to be retained in any relevant information system established under subsection (1).”
Amendment text
at end insert—
specifying how the work of the Information Centre will be overseen by the devolved administrations (or agencies accountable to them) in Scotland, Wales and Northern Ireland.”
specifying how the work of the Information Centre will be overseen by the devolved administrations (or agencies accountable to them) in Scotland, Wales and Northern Ireland.”
Amendment text
leave out “may” and insert “must”
Amendment text
at end insert—
The Secretary of State must by regulations set out the categories or types of information held by the Information Centre or other persons that are subject to the consent of the patient to whom the information relates.”
The Secretary of State must by regulations set out the categories or types of information held by the Information Centre or other persons that are subject to the consent of the patient to whom the information relates.”
Amendment text
at end insert—
In making regulations under subsection (1), and in the use of information provided by virtue of this section, the Secretary of State must have regard to the Caldicott principles, as set out in the Report on the Review of Patient-Identifiable Information, published in 1997, and the Information Governance Review, published in 2013.”
In making regulations under subsection (1), and in the use of information provided by virtue of this section, the Secretary of State must have regard to the Caldicott principles, as set out in the Report on the Review of Patient-Identifiable Information, published in 1997, and the Information Governance Review, published in 2013.”
Amendment text
Insert the following new Clause—
“Requirement for consultation with devolved authorities
“Requirement for consultation with devolved authorities
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Annual report on Medical Devices Information Systems
“Annual report on Medical Devices Information Systems
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Introduction of registries for patient safety
“Introduction of registries for patient safety
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 17 1
Amendment text
leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”
Clause 18 5
Amendment text
at end insert—
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Amendment text
Insert the following new Clause—
“Advisory committee
“Advisory committee
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
In subsection (1), leave out “may” and insert “must”
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
In subsection (2), leave out “may” and insert “must”
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
In subsection (3), leave out “may” and insert “must”
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 21 1
Amendment text
leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”
Clause 35 4
Amendment text
at end insert—
The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”
The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”
Amendment text
at end insert—
The Secretary of State may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices.”
The Secretary of State may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices.”
Amendment text
leave out “or (4)” and insert “, (4) or (4A)”
Amendment text
leave out “or (4)” and insert “, (4) or (4A)”
Clause 37 13
Amendment text
after “a” insert “relevant”
Amendment text
at end insert—
But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.”
But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.”
Amendment text
at end insert—
Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—
Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out “But”
Amendment text
at end insert—
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”
Amendment text
leave out line 32
Amendment text
at end insert—
““patient information” means information (however recorded) which—
““patient information” means information (however recorded) which—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
at end insert—
““relevant person” means—
““relevant person” means—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out “(7)” and insert “(8)”
Amendment text
at end insert—
In regulation 2 (interpretation), in paragraph (1) in the definition of “medical device”, after “software” insert “and algorithms including methodologies for the interpretation of data, and associated technical architecture,”.”
In regulation 2 (interpretation), in paragraph (1) in the definition of “medical device”, after “software” insert “and algorithms including methodologies for the interpretation of data, and associated technical architecture,”.”
Amendment text
leave out subsection (5)
Amendment text
Insert the following new Clause—
“Requirement for consolidated legislation: medical devices
“Requirement for consolidated legislation: medical devices
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Requirement for draft consolidated legislation
“Requirement for draft consolidated legislation
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 38 9
Amendment text
Insert the following new Clause—
“Independent Patient Safety Commissioner
“Independent Patient Safety Commissioner
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“International trade agreements
“International trade agreements
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Northern Ireland and regulatory divergence
“Northern Ireland and regulatory divergence
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Northern Ireland and regulatory divergence
“Northern Ireland and regulatory divergence
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Independent medicines and medical devices safety review: task force for implementation
“Independent medicines and medical devices safety review: task force for implementation
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Medicines and Medical Devices Redress Agency
“Medicines and Medical Devices Redress Agency
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Redress schemes
“Redress schemes
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Availability of medicines and medical devices for human use on the National Health Service
“Availability of medicines and medical devices for human use on the National Health Service
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Future regulatory alignment
“Future regulatory alignment
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 39 1
Amendment text
Insert the following new Clause—
“Requirement for draft consolidated legislation: medical devices
“Requirement for draft consolidated legislation: medical devices
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 40 5
Amendment text
Insert the following new Clause—
“Independent Patient Safety Commissioner
“Independent Patient Safety Commissioner
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Availability of medicines and medical devices for human use on the National Health Service
“Availability of medicines and medical devices for human use on the National Health Service
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Medicines and Medical Devices Redress Agency
“Medicines and Medical Devices Redress Agency
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Redress schemes
“Redress schemes
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Northern Ireland and regulatory divergence
“Northern Ireland and regulatory divergence
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 41 9
Amendment text
at end insert—
This section applies to regulations under a power in Part A1, 1, 2 or 3, apart from regulations under paragraph 9 of Schedule 1.”
This section applies to regulations under a power in Part A1, 1, 2 or 3, apart from regulations under paragraph 9 of Schedule 1.”
Amendment text
leave out “Regulations under sections 1(1), 9(1), 14(1) and 18(1)” and insert “The regulations”
Amendment text
leave out “consult such persons as the authority considers appropriate” and insert “carry out a public consultation.
In relation to proposed regulations under section 16(1), the Secretary of State must specifically consult—
In relation to proposed regulations under section 16(1), the Secretary of State must specifically consult—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
after “consult” insert “patients and end users directly affected by the regulations, and any other”
Amendment text
leave out from “consult” to end and insert “—
healthcare organisations;
healthcare organisations;
Amendment text
at end insert “which must include—
representatives of the relevant patient groups,
representatives of the relevant patient groups,
Amendment text
leave out subsection (3)
Amendment text
Insert the following new Clause—
“Reporting requirements
“Reporting requirements
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Duty to consult devolved administrations
“Duty to consult devolved administrations
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 42 12
Amendment text
leave out subsections (3) to (9) and insert—
The procedure for making regulations under Part 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—
The procedure for making regulations under Part 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out subsections (4) to (9) and insert—
Subject to subsection (11), regulations of a Northern Ireland department acting alone under section 1(1) or 8(1) may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly.
Subject to subsection (11), regulations of a Northern Ireland department acting alone under section 1(1) or 8(1) may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly.
Amendment text
leave out from “to” to “if” in line 9 and insert “the made affirmative procedure”
Amendment text
leave out from beginning to “if” in line 13 and insert “the confirmatory procedure under the Statutory Rules (Northern Ireland) Order 1979”
Amendment text
leave out sub-paragraph (iii)
Amendment text
leave out sub-paragraph (vii)
Amendment text
Insert the following new Clause—
“Expiry of powers
“Expiry of powers
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Time limits on delegated powers
“Time limits on delegated powers
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Expiry of powers
“Expiry of powers
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Made affirmative procedure
“Made affirmative procedure
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Super-affirmative procedure
“Super-affirmative procedure
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Super-affirmative procedure: Northern Ireland
“Super-affirmative procedure: Northern Ireland
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 43 3
Amendment text
after “Part” insert “A1,”
Amendment text
leave out “1(2) and (3), 9(2) and (3) or 14(2) and (3)” and insert “1, 9 or 14”
Amendment text
leave out from “to” to “, the” on line 40 and insert “any other regulations”
Clause 44 12
Amendment text
leave out “Secretary of State must lay before Parliament” and insert “relevant authority must lay before the appropriate legislature”
Amendment text
leave out “Secretary of State” and insert “relevant authority”
Amendment text
leave out “and 14(1)” and insert “, 14(1) and 18(1)”
Amendment text
leave out subsection (2) and insert—
In preparing a report, the relevant authority must consult—
In preparing a report, the relevant authority must consult—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
leave out “Secretary of State” and insert “relevant authority”
Amendment text
leave out “Secretary of State” and insert “relevant authority”
Amendment text
leave out “Secretary of State’s” and insert “relevant authority’s”
Amendment text
leave out “Secretary of State” and insert “relevant authority”
Amendment text
leave out “or 14(1)” and insert “, 14(1) or 18(1)”
Amendment text
leave out “or 14(1)” and insert “, 14(1) or 18(1)”
Amendment text
at end insert—
In this section—
In this section—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Amendment text
Leave out Clause 44 and insert the following new Clause—
“Commencement
“Commencement
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 45 8
Amendment text
after “Part” insert “A1,”
Amendment text
after “Part” insert “A1,”
Amendment text
column 2, leave out paragraph (b)
Amendment text
column 2, leave out paragraph (b)
Amendment text
leave out line 12
Amendment text
after “Part” insert “A1,”
Amendment text
Insert the following new Clause—
“Super-affirmative procedure
“Super-affirmative procedure
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
Insert the following new Clause—
“Super-affirmative procedure: Northern Ireland
“Super-affirmative procedure: Northern Ireland
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Clause 47 3
Amendment text
at end insert—
section 5(4),”
section 5(4),”
Amendment text
at end insert—
Part A1,”
Part A1,”
Amendment text
leave out “section 18” and insert “Chapter 2 of Part 3”
Clause 52 6
Amendment text
leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”
Amendment text
leave out “order” and insert “regulations”
Amendment text
leave out “ an order” and insert “regulations”
Amendment text
leave out “order in its initial form, or a revised draft order” and insert “regulations in their original form, or revised draft regulations”
Amendment text
leave out “order”
Amendment text
leave out “order”
Schedule 1 2
Amendment text
Insert the following new Schedule—
“SCHEDULE A1
“SCHEDULE A1
Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.
Amendment text
leave out “have regard to” and insert “act in accordance with”
Schedule 2 1
Amendment text
at end insert—
In respect of an offence under this regulation—
In respect of an offence under this regulation—
The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.
Other amendments 1
Amendment text
at beginning insert “Make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices;”