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Lord Darzi of Denham
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Darzi of Denham, Lord (27)
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To ask Her Majesty's Government how many applications have now been received by the Medicines and Healthcare Products Regulatory Agency for the registration of products under the provisions of the Traditional Herbal Medicinal Products Directive; in how many of those applications the registration has (a) been accepted, (b) been rejected,...
To ask Her Majesty's Government how many applications have now been received by the Medicines and Healthcare Products Regulatory Agency for the registration of products under the provisions of the Traditional Herbal Medicinal Products Directive; in how many of those applications the registration has (a) been accepted, (b) been rejected,...
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
16 June 2009
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 70 applications to register products under the traditional herbal registration scheme implemented in line with the requirements of Directive 2004/24/EC. 31 registrations have been granted and the remaining 39 applications are under assessment. To date no applications have been refused.
A wide range of European guidelines is available for industry, for example on meeting the relevant quality and manufacturing standards. We recognise that moving from a largely unregulated environment into systematic medicines regulation represents a significant challenge for parts of the over-the-counter herbal medicines sector. Accordingly, the MHRA has been running a programme to manage the regulatory impact of the directive. Initiatives have included provision of additional national guidance, workshops and regular dialogue with the industry's Herbal Forum. The MHRA also provides the opportunity for individual companies seeking to register products under the scheme to be given regulatory and scientific advice. The MHRA has no plans to end this advice service, however, our expectation is that, as with any such new scheme, with growing experience, more companies will become confident in operating under these regulatory arrangements.
Subjects
EU law; Registration; Medicines and Healthcare products Regulatory Agency; Herbal medicine
Date
16 June 2009
Reference
4004; 711 c197WA
House
House of Lords
To ask Her Majesty's Government whether it remains their policy that the Medicines and Healthcare Products Regulatory Agency will seek to assist the herbal medicines sector with its efforts to comply with the provisions of the Traditional Herbal Medicines Directive.
To ask Her Majesty's Government whether it remains their policy that the Medicines and Healthcare Products Regulatory Agency will seek to assist the herbal medicines sector with its efforts to comply with the provisions of the Traditional Herbal Medicines Directive.
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
16 June 2009
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 70 applications to register products under the traditional herbal registration scheme implemented in line with the requirements of Directive 2004/24/EC. 31 registrations have been granted and the remaining 39 applications are under assessment. To date no applications have been refused.
A wide range of European guidelines is available for industry, for example on meeting the relevant quality and manufacturing standards. We recognise that moving from a largely unregulated environment into systematic medicines regulation represents a significant challenge for parts of the over-the-counter herbal medicines sector. Accordingly, the MHRA has been running a programme to manage the regulatory impact of the directive. Initiatives have included provision of additional national guidance, workshops and regular dialogue with the industry's Herbal Forum. The MHRA also provides the opportunity for individual companies seeking to register products under the scheme to be given regulatory and scientific advice. The MHRA has no plans to end this advice service, however, our expectation is that, as with any such new scheme, with growing experience, more companies will become confident in operating under these regulatory arrangements.
Subjects
EU law; Registration; Medicines and Healthcare products Regulatory Agency; Herbal medicine
Date
16 June 2009
Reference
4005; 711 c197WA
House
House of Lords
To ask Her Majesty's Government how many care companies the Commission for Social Care Inspection closed down during its period of office.
To ask Her Majesty's Government how many care companies the Commission for Social Care Inspection closed down during its period of office.
Asked by
Lord Ashley of Stoke
(Labour)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
20 May 2009
I am informed by the Care Quality Commission (CQC) that the Commission for Social Care Inspection (CSCI) had the power to cancel the registration of individual care services such as care homes, nursing homes and domiciliary care agencies. CSCI also had powers to cancel the registration of registered managers. CQC retains CSCI's powers of enforcement.
Cancellation of registration is not necessarily equivalent to closing down a care company, as such providers may hold multiple registrations for individual services provided, or managers registered, in various locations.
During its period of office, from 2004-05 to 2008-09, CSCI carried out 309 non-urgent and 28 urgent cancellations of registration.
Subjects
Care homes; Closures; Home care services; Registration; Commission for Social Care Inspection
Date
20 May 2009
Reference
3533; 710 c335WA
House
House of Lords
To ask Her Majesty's Government what action they will take to ensure that whistle-blowing in the NHS is not discouraged by fear of loss of professional registration.
To ask Her Majesty's Government what action they will take to ensure that whistle-blowing in the NHS is not discouraged by fear of loss of professional registration.
Asked by
Baroness Finlay of Llandaff
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
14 May 2009
The Public Interest Disclosure Act 1998 (PIDA) gives full protection of the law to staff who whistleblow in the public interest and the penalties for those who penalise staff for doing so are potentially very severe. The department has therefore, in light of the Act, made it clear that every National Health Service trust should have in place local policies and procedures that comply with the Act. Decisions on professional registration are made by independent regulatory bodies, not the Government, but we would expect them to make their decisions cognisant of a national context that encourages whistleblowing.
Subjects
Disclosure of information; Health professions; NHS; Registration
Date
14 May 2009
Reference
3189; 710 c236WA
House
House of Lords
Further to the Written Answer by Lord Darzi of Denham on 29 October (WA 171), what is the timetable for the publication of the next-steps document and consultation on modernising scientific careers.
Further to the Written Answer by Lord Darzi of Denham on 29 October (WA 171), what is the timetable for the publication of the next-steps document and consultation on modernising scientific careers.
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
26 November 2008
We expect to publish the modernising scientific careers next steps document in November 2008. It will offer a way forward for the regulation of the totality of the healthcare science workforce. The latter will be subject to a separate consultation in 2009 and all matters relating to the regulation of clinical physiologists will be considered.
Issues relating to the current practice of clinical physiologists are for local clinical governance procedures.
Subjects
Career development; Health professions; Registration; Regulation; Scientists; Physiology
Date
26 November 2008
Reference
705 c317-8WA; 6434
House
House of Lords
asked Her Majesty's Government:What assessment they have made of clinical physiologists performing high-risk procedures, both invasive and non-invasive, on patients; and what guidance they have issued to primary care trusts on clinical physiologists performing high-risk procedures on patients; and
asked Her Majesty's Government:What assessment they have made of clinical physiologists performing high-risk procedures, both invasive and non-invasive, on patients; and what guidance they have issued to primary care trusts on clinical physiologists performing high-risk procedures on patients; and
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
26 November 2008
We expect to publish the modernising scientific careers next steps document in November 2008. It will offer a way forward for the regulation of the totality of the healthcare science workforce. The latter will be subject to a separate consultation in 2009 and all matters relating to the regulation of clinical physiologists will be considered.
Issues relating to the current practice of clinical physiologists are for local clinical governance procedures.
Subjects
Career development; Health professions; Registration; Regulation; Scientists; Physiology
Date
26 November 2008
Reference
705 c317-8WA; 6432
House
House of Lords
What assessment they have made of the impact of the modernising scientific careers programme on the voluntary registration system for clinical physiology; and
What assessment they have made of the impact of the modernising scientific careers programme on the voluntary registration system for clinical physiology; and
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
26 November 2008
We expect to publish the modernising scientific careers next steps document in November 2008. It will offer a way forward for the regulation of the totality of the healthcare science workforce. The latter will be subject to a separate consultation in 2009 and all matters relating to the regulation of clinical physiologists will be considered.
Issues relating to the current practice of clinical physiologists are for local clinical governance procedures.
Subjects
Career development; Health professions; Registration; Regulation; Scientists; Physiology
Date
26 November 2008
Reference
705 c317-8WA; 6433
House
House of Lords
What estimate they have made of the costs per product of conducting tests to demonstrate compliance with the key provisions of the European Medicines Agency guidance on applications for registration under the traditional herbal medicinal products directive.
What estimate they have made of the costs per product of conducting tests to demonstrate compliance with the key provisions of the European Medicines Agency guidance on applications for registration under the traditional herbal medicinal products directive.
Asked by
Baroness Howe of Idlicote
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) would expect some rationalisation in the manufacturing of herbal medicines reflecting the fact that to carry out this activity safely to systematic standards within a regulated environment requires specialist expertise. It is likely that some manufacturers lacking such specialist expertise may withdraw from the market. However, there is no basis on which to make specific estimates. Feedback to the agency from individual companies suggests that many are still developing their plans for registering products under the traditional herbal registration (THR) scheme. So far 14 companies have submitted applications to register one or more products in the UK under the scheme and we therefore anticipate that there will be a competitive market. It is not possible to estimate the impact of the THR scheme on retailers. One factor is likely to be improved consumer confidence in products made to assured standards.
The guidelines on the quality of herbal medicinal products prepared by the European Medicines Agency largely reflect good practice identified by the herbal industry. In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Costs; EU law; Registration; Herbal medicine
Date
29 September 2008
Reference
5064; 703 c364-5WA
House
House of Lords
What statistics they have collected about the number of specialist retailers of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and
What statistics they have collected about the number of specialist retailers of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and
Asked by
Baroness Howe of Idlicote
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) would expect some rationalisation in the manufacturing of herbal medicines reflecting the fact that to carry out this activity safely to systematic standards within a regulated environment requires specialist expertise. It is likely that some manufacturers lacking such specialist expertise may withdraw from the market. However, there is no basis on which to make specific estimates. Feedback to the agency from individual companies suggests that many are still developing their plans for registering products under the traditional herbal registration (THR) scheme. So far 14 companies have submitted applications to register one or more products in the UK under the scheme and we therefore anticipate that there will be a competitive market. It is not possible to estimate the impact of the THR scheme on retailers. One factor is likely to be improved consumer confidence in products made to assured standards.
The guidelines on the quality of herbal medicinal products prepared by the European Medicines Agency largely reflect good practice identified by the herbal industry. In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Costs; EU law; Registration; Herbal medicine
Date
29 September 2008
Reference
5063; 703 c364-5WA
House
House of Lords
asked Her Majesty's Government:What statistics they have collected about the number of specialist manufacturers and distributors of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and
asked Her Majesty's Government:What statistics they have collected about the number of specialist manufacturers and distributors of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and
Asked by
Baroness Howe of Idlicote
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) would expect some rationalisation in the manufacturing of herbal medicines reflecting the fact that to carry out this activity safely to systematic standards within a regulated environment requires specialist expertise. It is likely that some manufacturers lacking such specialist expertise may withdraw from the market. However, there is no basis on which to make specific estimates. Feedback to the agency from individual companies suggests that many are still developing their plans for registering products under the traditional herbal registration (THR) scheme. So far 14 companies have submitted applications to register one or more products in the UK under the scheme and we therefore anticipate that there will be a competitive market. It is not possible to estimate the impact of the THR scheme on retailers. One factor is likely to be improved consumer confidence in products made to assured standards.
The guidelines on the quality of herbal medicinal products prepared by the European Medicines Agency largely reflect good practice identified by the herbal industry. In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Costs; EU law; Registration; Herbal medicine
Date
29 September 2008
Reference
5062; 703 c364-5WA
House
House of Lords
asked Her Majesty's Government:Further to the Written Answer by Lord Darzi of Denham on 22 July (cols. WA 254–255), (a) what estimate they have made of the cost of commissioning chromatographic fingerprinting tests for multi-ingredient herbal remedies; and (b) when Ministers last met representatives of the European Commission to discuss...
asked Her Majesty's Government:Further to the Written Answer by Lord Darzi of Denham on 22 July (cols. WA 254–255), (a) what estimate they have made of the cost of commissioning chromatographic fingerprinting tests for multi-ingredient herbal remedies; and (b) when Ministers last met representatives of the European Commission to discuss...
Asked by
Lord Pearson of Rannoch
(UK Independence Party)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
In its regulatory impact assessment of the traditional herbal registration (THR) scheme, the Medicines and Healthcare Products Regulatory Agency (MHRA) estimated that typically the overall costs of registering a product under the scheme, including the cost associated with chromatographic testing, could be several tens of thousand pounds. It was anticipated that this figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
Ministers have not met representatives of the European Commission to discuss the impact of the traditional herbal medicines directive. However, the Government do take the issue of regulatory impact very seriously and continue to seek ways of minimising its impact. In its response to the Commission's 2007 review of the early operation of the directive, the MHRA stressed the need to carefully manage and minimise regulatory impact while not compromising public health. MHRA's response to the Commission is available on its website at: www.mhra.gov.uk/Publications/Consultations/CON2031524.
Notes
Answer received between Tuesday 16 September and Monday 22 September 2008
Subjects
Costs; EU law; Registration; Testing; Herbal medicine
Date
29 September 2008
Reference
5309; 703 c415-6WA
House
House of Lords
What was the outcome of the recent review of the operation of the traditional herbal medicinal products directive (2004/24/EC) undertaken by the European Commission; what period was covered by the review; and whether they intend to press for the review to be repeated now that the directive is in force.
What was the outcome of the recent review of the operation of the traditional herbal medicinal products directive (2004/24/EC) undertaken by the European Commission; what period was covered by the review; and whether they intend to press for the review to be repeated now that the directive is in force.
Asked by
Earl Howe
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
It is a commercial decision for individual companies whether to apply for a traditional herbal registration (THR) under the provisions flowing from directive 2004/24/EC. The Medicines and Healthcare products Regulatory Agency (MHRA) is not in a position to estimate how many applications will be submitted. So far the MHRA has received 38 THR applications, of which 33 are for products containing a single active ingredient and five are for combination products. The MHRA expects that a high proportion of early applications will be for relatively simple products while companies become accustomed to meeting the regulatory requirements of the scheme.
There is normally no requirement for applicants to submit information on the efficacy of the product under the THR scheme. The quality requirements for herbal medicinal products and traditional herbal medicinal products are set out in detailed guidance documents following consultation with industry. The European Pharmacopoeia also sets out legally binding standards for herbal ingredients as well as excipients used in herbal medicinal products. The purpose of the quality tests is to ensure that the herbal medicinal product is safe for use and has a reproducible quality over its proposed shelf-life. Tests are required to ensure that the correct plant materials are used, free from potentially hazardous contaminants such as pesticide residues, fumigant residues, heavy metals/other toxic elements, mycotoxins, bacteria/fungi. Where herbal extracts are employed tests are required on all materials used, including solvents and reagents used for extraction, to ensure that they are as intended and of acceptable quality. The herbal extract undergoes tests to ensure it is of reproducible quality and that it is free from hazardous levels of, for example, residual solvents, micro-organisms or potential contaminants from the starting plant materials. The finished dosage form is tested to ensure that it contains the declared amount of herbal ingredients and that it will remain of suitable quality throughout the proposed shelf-life.
In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
European and United Kingdom medicines legislation requires manufacturers and/or importers of registered traditional herbal medicines for human use to hold a manufacturer's licence. It is a condition of such a licence that the holder must have a qualified person (QP). The QP must either meet existing specific educational and vocational requirements or attain status through transitional arrangements. The QP has a personal responsibility for certifying that each batch of registered traditional herbal medicine has undergone the appropriate tests, complies with its registered specification and has been manufactured in accordance with good manufacturing practice. The purpose of these requirements is to ensure that a safe quality traditional herbal medicine is placed on the market.
The directive on traditional herbal medicinal products requires manufacturers of registered herbal medicines to be authorised by the national competent authority. In the UK, the MHRA authorises and inspects manufacturers. The inspection fee is currently £1,496 for a full day and £920 for half a day. Manufacturers must meet certain conditions and employ a QP in order to be authorised. A number of manufacturers were already authorised to manufacture herbal medicines before the directive came into force. Since the implementation of the directive all of the small number of manufacturers who have applied specifically to manufacture registered herbal medicines have been authorised.
The European Commission launched a public consultation in May 2007 on the review of the operation of directive 2004/24/EC. The consultation included data up to March 2007. It is the European Commission's responsibility to report on the findings of that review and, pending that outcome, we have no present plans to press for an early second review.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Costs; Fees and charges; Inspections; EU law; Manufacturing industries; Standards; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
703 c360-2WA; 5131
House
House of Lords
How many applications have been made to date for registration of herbal products under the provisions of the traditional herbal medicinal products directive; and
How many applications have been made to date for registration of herbal products under the provisions of the traditional herbal medicinal products directive; and
Asked by
Baroness Gardner of Parkes
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
5056; 703 c362-4WA
House
House of Lords
asked Her Majesty's Government:Which herbal products are currently available on the market under Section 12(2) of the Medicines Act 1968; and for which of those products an application has been received by the Medicines and Healthcare products Regulatory Agency for registration under the traditional herbal medicinal products directive (2004/24/EC); and
asked Her Majesty's Government:Which herbal products are currently available on the market under Section 12(2) of the Medicines Act 1968; and for which of those products an application has been received by the Medicines and Healthcare products Regulatory Agency for registration under the traditional herbal medicinal products directive (2004/24/EC); and
Asked by
Baroness Gardner of Parkes
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
5020; 703 c362-4WA
House
House of Lords
When Ministers last visited the facilities of small and medium-sized manufacturers of specialist herbal remedies to discuss the impact on their business of the traditional herbal medicinal products directive.
When Ministers last visited the facilities of small and medium-sized manufacturers of specialist herbal remedies to discuss the impact on their business of the traditional herbal medicinal products directive.
Asked by
Baroness Gardner of Parkes
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
703 c362-4WA; 5059
House
House of Lords
What estimate the Medicines and Healthcare products Regulatory Agency has made of the number of herbal remedies currently marketed in the United Kingdom under Section 12(2) of the Medicines Act 1968; for how many and what percentage of those products an application has been received by the agency for registration...
What estimate the Medicines and Healthcare products Regulatory Agency has made of the number of herbal remedies currently marketed in the United Kingdom under Section 12(2) of the Medicines Act 1968; for how many and what percentage of those products an application has been received by the agency for registration...
Asked by
Baroness Gardner of Parkes
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
5057; 703 c362-4WA
House
House of Lords
What their objectives are in relation to the future availability of popular herbal remedies; and what specific steps they are taking to achieve that objective; and
What their objectives are in relation to the future availability of popular herbal remedies; and what specific steps they are taking to achieve that objective; and
Asked by
Baroness Gardner of Parkes
(Conservative)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
703 c362-4WA; 5058
House
House of Lords
asked Her Majesty's Government:How many applications for product registrations under the traditional herbal medicinal products directive (2004/24/EC) have been received to date by the Medicines and Healthcare products Regulatory Agency; and in how many of those cases have approvals been given; and
asked Her Majesty's Government:How many applications for product registrations under the traditional herbal medicinal products directive (2004/24/EC) have been received to date by the Medicines and Healthcare products Regulatory Agency; and in how many of those cases have approvals been given; and
Asked by
Lord Clement-Jones
(Liberal Democrat)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over-the-counter herbal medicines made to assured standards of safety, quality and product information. The likelihood of increased consumer confidence in the standards of products, including the reliability of product information, could also be of benefit to responsible specialist manufacturers and retailers.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a THR. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The MHRA continues to provide a range of help to companies aimed at assisting them to progress plans to register products, including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website.
From 30 April 2011 no herbal medicine within the scope of directive 2004/24/EC may be placed on the UK market or distributed by way of wholesale dealing without a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation. We have no plans to ask the European Commission to propose legislation extending the deadline in directive 2004/24/EC.
The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for a single existing ingredient to £7,480 for complex new products. The fees charged by the MHRA are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with Treasury guidance.
MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Fees and charges; EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
5100; 703 c359-60WA
House
House of Lords
What assessment they have both made of the regulatory impact of the traditional herbal medicinal products directive (2004/24/EC), in particular on (a) small and medium-sized specialist manufacturers of herbal remedies, (b) specialist retailers, and (c) consumer choice; and
What assessment they have both made of the regulatory impact of the traditional herbal medicinal products directive (2004/24/EC), in particular on (a) small and medium-sized specialist manufacturers of herbal remedies, (b) specialist retailers, and (c) consumer choice; and
Asked by
Lord Clement-Jones
(Liberal Democrat)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over-the-counter herbal medicines made to assured standards of safety, quality and product information. The likelihood of increased consumer confidence in the standards of products, including the reliability of product information, could also be of benefit to responsible specialist manufacturers and retailers.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a THR. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The MHRA continues to provide a range of help to companies aimed at assisting them to progress plans to register products, including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website.
From 30 April 2011 no herbal medicine within the scope of directive 2004/24/EC may be placed on the UK market or distributed by way of wholesale dealing without a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation. We have no plans to ask the European Commission to propose legislation extending the deadline in directive 2004/24/EC.
The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for a single existing ingredient to £7,480 for complex new products. The fees charged by the MHRA are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with Treasury guidance.
MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Fees and charges; EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
703 c359-60WA; 5101
House
House of Lords
What assessment they have made of the numbers of herbal products that have historically been marketed under Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence; how many and what percentage of those products they anticipate will need to secure registrations under the...
What assessment they have made of the numbers of herbal products that have historically been marketed under Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence; how many and what percentage of those products they anticipate will need to secure registrations under the...
Asked by
Lord Clement-Jones
(Liberal Democrat)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
29 September 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over-the-counter herbal medicines made to assured standards of safety, quality and product information. The likelihood of increased consumer confidence in the standards of products, including the reliability of product information, could also be of benefit to responsible specialist manufacturers and retailers.
Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a THR. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The MHRA continues to provide a range of help to companies aimed at assisting them to progress plans to register products, including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website.
From 30 April 2011 no herbal medicine within the scope of directive 2004/24/EC may be placed on the UK market or distributed by way of wholesale dealing without a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation. We have no plans to ask the European Commission to propose legislation extending the deadline in directive 2004/24/EC.
The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for a single existing ingredient to £7,480 for complex new products. The fees charged by the MHRA are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with Treasury guidance.
MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.
Notes
Answer received between Tuesday 19 August and Tuesday 26 August 2008
Subjects
Fees and charges; EU law; Medicines and Healthcare products Regulatory Agency; Registration; Herbal medicine
Date
29 September 2008
Reference
5102; 703 c359-60WA
House
House of Lords