This snapshot, taken on 09/08/2010, shows web content selected for preservation by The National Archives. External links, forms and search boxes may not work in archived websites.

If you work within an NHS trust, please switch to our dedicated NHS website: nww.pasa.nhs.uk


Advisory Committee on Borderline Substances (ACBS)

The Advisory Committee on Borderline Substances (ACBS) is the committee responsible for advising approved prescribers on the prescribing of certain foodstuffs and toiletries. The ACBS was established in 1971 and is an advisory non-departmental public body (NDPB), non-statutory and UK-wide.

Borderline substances are mainly foodstuffs, such as enteral feeds and foods that are specially formulated for people with medical conditions, but also include some toiletries, such as sun blocks for use by people with conditions such as photodermatosis.

About the Advisory Committee on Borderline Substances

Notes for applicants wishing to make nutritional submissions to the ACBS  

The ACBS has reviewed this information and the updated ‘Information Notes/Application for a nutritional product to be considered for approval for re-imbursement at NHS expense’ is now available.

Applicants wishing to make a nutritional application to the ACBS should note the following:

  • The application must be submitted using the application information notes on this website (Information notes / application for a nutritional product to be considered for approval for re-imbursement at NHS expense).
  • When making an application, the ‘Information Notes / Application’ should be used as a template with the statements supporting an application appearing underneath the relevant paragraph.
  • Responses should be made in blue (black may be used as an alternative), 12 point, Times New Roman font.
  • No information other than that which has been requested should be attached.
  • Applications (Type 1 and Type 2 only) must be accompanied by an exemption form from the Medicines and Healthcare Products Regulatory Agency (MHRA).
Applicants must confirm that the product is not registered / nor in the process of being registered in line with the Medical Devices Directive.
Any information sent to the MHRA (i.e. information on the ingredients, copies of the packaging, information leaflets and promotional material) must be exactly the same as the information submitted to the ACBS, otherwise the MHRA certificate will not be valid.  If any discrepancy between the two submissions is found, the ACBS will advise the MHRA who may then require a complete re-submission to confirm the original certification.
Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Applications must be accompanied by an ‘Application summary form for nutritional products to be considered for approval for re-imbursement at NHS expense’.

Application summary form - nutritional products

Information notes / application - nutritional products

Appendix 1                 Appendix 2                  Appendix 3 

Appendix 4                 Appendix 5                  Appendix 6 

Appendix 7

Notes for applicants wishing to make dermatological submissions to the ACBS 

The ACBS is in the process of reviewing and updating the ‘Application for dermatological products to be considered for approval for re-imbursement at NHS expense’.

In the meantime, applicants wishing to make a dermatological application to the ACBS should note the following:

  • Applications should be based upon the submission guidance on this website, ‘Notes of guidance to manufacturers about information to be included in submissions for dermatological products to be considered for re-imbursement at NHS expense’.
  • Applications must be accompanied by an exemption form from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Applicants must confirm that the product is not registered / nor in the process of being registered in line with the Medical Devices Directive.

Any information sent to the MHRA must be exactly the same as the information submitted to the ACBS, otherwise the MHRA certificate will not be valid.  If any discrepancies between the two submissions are found, the ACBS will advise the MHRA who may then require a complete re-submission to confirm the original certification.
Medicines and Healthcare Products Regulatory Agency (MHRA)

  • Applications must be accompanied by an ‘Application summary form for dermatological products to be considered for approval for re-imbursement at NHS expense’.

Application summary form - dermatological products

Guidance notes - dermatological products

Notes for applicants wishing to make price changes to ACBS approved products

This pricing document forms part of a series of related Information Notes which the ACBS will use when considering applications.  The aim of this document is to ensure consistency and transparency in the pricing of ACBS products.

The procedures outlined in this document will be implemented from 1 April 2010.

Information Notes on the pricing of ACBS products 

Submitting to the ACBS

Seventeen copies of the completed application should be sent to NHS Commercial Medicines Unit (formerly the pharmacy directorate of the NHS Purchasing and Supply Agency at the address below:

The Secretariat
Advisory Committee on Borderline Substances
NHS Commercial Medicines Unit
Castle View House
East Lane
Runcorn
Cheshire WA7 2AA

Note: The changes identified in a Type 3 Application are normally considered by the ACBS to be 'minor changes' and, as such, will not require 17 copies of the completed Application. Two copies only of the Application should be submitted initially. If the Chairman decides that the Application should go before the full Committee for discussion, a further 15 copies will be required.  

 

 

Samples of the product, if available, preferably in the draft packaging must be provided for the ACBS’s inspection (one sample of each product being submitted will suffice).
The deadline for fully completed applications is normally seven weeks prior to the committee meeting date.
Late or incomplete applications will not be accepted.
Applicants are advised that they must not contact members of the ACBS directly regarding their applications or to seek advice on potential applications.  All correspondence with regards to ACBS matters must be made through the ACBS Secretariat.
 

ACBS meetings 

The Advisory Committee on Borderline Substances will next meet on 30 March 2010 - submission deadline 9 February 2010.

Meeting dates for 2010 are as follows:
  • 30 March
  • 6 July
  • 9 November
 

ACBS members

The current committee members are appointed until 2011
Full members  
Chair: Dr Ian R White Consultant Dermatologist
Dr James R Courtney General Practitioner
Professor Stephen Jackson Professor of Clinical Gerontology
Dr Pamela Mason Pharmacist, freelance pharmaceutical and nutritional writer and consultant
Professor David Silk Consultant Gastroenterologist and Director of the Department of Gastroenterology and Nutrition
Co-opted members  
Mr V'Iain Fenton-May Specialist Pharmacist, Quality Control
Ms Vanessa Shaw Head of Dietetics
Ms Clare Soulsby Principal Dietitian
Ms Vera Todorovic Consultant Dietitian in Clinical Nutrition
Mr Richard Wilson Director of Nutrition and Dietetics
 

The exception to the above procedure is a Type 3 application for price changes.  For this type of application a covering letter detailing the product, presentation, current price, proposed price and the percentage change based on the current RPI (excluding mortgages) will suffice.




E Class

D
Contact

Email: ACBS@pasa.nhs.uk
Name: Advisory Committee on Borderline Substances



 
floating page organizer floating page organizer