ADVISORY COMMITTEE ON BORDERLINE SUBSTANCES
INFORMATION NOTES / APPLICATION FOR A NUTRITIONAL PRODUCT TO BE
CONSIDERED BY THE ACBS
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When making an application, the Information Notes / Application must be
downloaded in its entirety and used as a template with the statements
supporting an application appearing under the relevant paragraph
Applicants must respond to each and every requirement as indicated and
provide a statement that the requirement either can or cannot be met along with
supporting evidence
Information must be provided under the relevant paragraph and statements
should not be made that refer to the information being given in supporting
documents, e.g. refer to data sheet, appendices, etc.
Note: copies of documents must not be scanned into this form. Hard copies,
e.g. data sheet, manufacturing certificate are required as an essential
component of the application
Applicants must conform to this format and layout
All information must be provided in English
For Type 3 applications, only the relevant paragraphs of the Information Notes /
Application that are applicable to the nature of the change must be attached to
the Application Summary Form. See Appendix 2.1 for further details
Applications, including Type 3 applications, which do not conform to the
above requirements, WILL NOT be accepted
1.
CATEGORISATION OF NUTRITIONAL PRODUCTS (All applications)
See Appendix 1 for further information
Category 1 Non-disease specific enteral tube feeds
Category 2 Non-disease specific oral nutritional supplements
Category 3 Nutritional products for specific clinical conditions
Category 4 Nutritional products designed for the specific management of
inherited metabolic disorders
Category 5 Staple food products designed to optimise nutritional status as part of
the clinical management of formally diagnosed chronic disease states
Category 6 Nutritional products designed to enhance the safety and / or
acceptability of foods or feeds which are prescribable in any of the
above categories
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Note: While a degree of choice of all the above items may be important to
facilitate compliance, it is not intended that an infinite variety of broadly similar
products should be available on prescription at NHS expense. Other factors being
equal, normally price will be an important determinant.
2.
TYPE OF APPLICATION (All applications)
See Appendix 2 for further information
Note: Applicants of Type 1 and Type 2 applications are advised that preliminary
advice from the ACBS / a designated representative of the ACBS might be helpful
in order to confirm the Type / categorisation of the product being submitted. No
face to face meetings / telephone conversations will be held with Applicants.
Correspondence must be conducted via e-mail, through the Secretariat. This is to
ensure transparency and a clear audit trail.
Type 1
New formulations which the Applicant perceives to have well
characterised and substantiated advantages in terms of nutritional
composition and patient tolerance / acceptability
Type 2
Formulations which are broadly similar in composition to existing
products already on the market and which could be considered to be
suitable alternatives
Note: ‘Broadly similar’ refers to the ability to compare the product with
other products in the same sub category
Type 3
3.
Existing products to which minor changes (including price) are
proposed – for more information see paragraph 5.3
MEDICINES ACT (Type 1, Type 2 and relevant Type 3 applications)
For Pharma Form products only, a statement of exemption from the licensing
and other provisions of the Human Medicines Regulations 2012 (as amended)
must be obtained prior to any submission to the Advisory Committee on Borderline
Substances by contacting the Medicines and Healthcare products Regulatory
Agency (MHRA), Medicines Borderline Section, 151 Buckingham Palace Road,
London, SW1W 9SZ, enclosing details of the product to be considered.
Pharma Form products include:
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Sterile Liquids
Sterile Powders
Tablets
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Capsules
Powders (this does not include powders that are made into liquids for drinks;
e.g. Infant formula, meal replacement drinks or breads)
Creams
Ointments
Bath Oils
For these products the current procedures must continue to be followed, working to
the published MHRA deadlines.
A Statement of exemption from the licensing and other provisions of the Human
Medicines Regulations 2012 (as amended) for all other products (i.e. Non Pharma
Form) is not required.
Note - Specialist nutritional products, which include enteral tube feeds and
oral nutritional supplements, are classed by the MHRA as ‘non’ Pharma
Form’ products.
Details of any relevant Type 3 changes (Pharma Form only), as listed below, must
also be sent to the MHRA via their on-line ACBS form. A copy of the resulting
MHRA response must be included within the Type 3 application.
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alterations in product formulation / data sheets
product name change
changes to packaging / labelling
Please refer to Appendix 2 and Appendix 2.1 for further information about any of
the above
Any information sent to the MHRA for Pharma Form products (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 applications is found, the ACBS will advise the MHRA who may then require a
complete re-submission to confirm the original certification.
If there are ‘non’ Pharma Form applications about which the ACBS is unclear (in
terms of the products status under Medicines Regulations), then the ACBS
Secretariat will copy and send the relevant documents (label / packaging, data
sheet and product formulation) to the MHRA, via e-mail.
The MHRA will review these documents and make their decision about whether or
not a statement of exemption from the licensing and other provisions of the Human
Medicines Regulations 2012 (as amended) needs to be issued. If the MHRA’s
decision is to issue the statement of exemption then the ACBS Secretariat will
include a copy within the submission and forward an electronic copy to the
applicant.
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Should the MHRA require the applicant to make changes to the labels, packaging,
data sheet etc, the MHRA will liaise directly with the applicant. Once the issues
have been resolved the MHRA will advise both the company and the ACBS
Secretariat. Alternatively, the MHRA will inform the ACBS Secretariat that a
statement of exemption is not required.
If the MHRA have not reached a decision as to whether a statement of exemption
is required within 4 weeks of the ACBS meeting date, then the application will not
be considered at the forthcoming meeting. In such circumstances the ACBS
Secretariat will retain the applications for consideration at the following meeting,
once the MHRA have advised on their decision.
If a product is not classified as a medicine by the MHRA, this does not mean that it
will automatically be considered for approval by the ACBS.
Applicants must confirm that the product is not registered / nor in the process of
being registered in line with the Medical Devices Directive.
4.
FORMULATION (Type1, Type 2 and relevant Type 3 applications)
4.1
Ingredients and nutritional information
4.1.1 A complete quantitative formulation must be provided including a full
list of ingredients, additives and potential allergens together with
confirmation that these comply with all relevant UK / EC legislation.
In addition the unique identifiers (see also 4.6) must be given where
applicable.
4.1.2 A hard copy of the data sheet must also be provided within each
application.
This must also comply with the requirements of the relevant UK / EC
legislation (see Appendix 3). The data sheet must show the date on
which the sheet was produced together with the date(s) of any
revision(s). The country in which the data originated must also
be shown.
4.1.3 If the product is to be reconstituted, diluted or otherwise altered,
information will be required in respect of the nutritional composition as fed.
The statement below must be signed and dated by an appropriately
competent and authorised individual describing their status and
accepting legal responsibility for the validity of the evidence provided
on behalf of the Applicant.
On behalf of the applicant, I accept legal responsibility for the
accuracy of all the information provided in paragraph 4.1.1 to 4.1.3 and
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confirm that the application conforms to all legal requirements
Name:
Status:
Signature:
Date:
Note: at least one copy of the application must contain an original signature
4.2
Nutritional composition
The following information must be provided in addition:
4.2.1 Composition, percentage and source of nitrogen, sub-groups of
sugars, fibres and sub-groups of fats.
4.2.2 Information about any protein hydrolysis including:
 Whole protein source 
 Degree of hydrolysis i.e. chain lengths
 Source of enzymes used for hydrolysis
 Proportion as free amino acids
 Whether there is any trace of enzyme or whole protein
remaining in the product 
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4.2.3 Information about any carbohydrate hydrolysis including:
 Carbohydrate source
 Source of enzymes used for hydrolysis
 Whether there is any trace of enzyme remaining in the product
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4.2.4 Nutrient composition should be provided in mmol (SI / Système
Internationale) units as well as in milligrams, SI being the standard
unit of clinical measurement in the UK. This applies specifically to the
electrolyte composition and the expectation is that mmol will be
stated on any nutrient profiles provided within the text of the
application, label and data card to improve patient safety.
Note: Electrolytes in this context include sodium, potassium,
chloride, calcium, phosphorus (in mg and as phosphate in mmol) and
magnesium.
4.2.5 Nutritional composition per 100ml and per container of liquid product
or per 100g of powdered product must be given.
Note: The nutritional content of powdered product should also be
given per 100ml reconstituted product if practical. The amount used
in any standard dilution must be stated.
4.2.6 Potential renal solute load.
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4.2.7 Osmolality / Osmolarity.
4.2.8 Fatty acids.
 The total amounts of poly-unsaturated and saturated fatty
acids and the ratio between them
 Source and ratio of n6: n3 fatty acids
 Amount (g) of long chain polyunsaturated fatty acids where
added
 Amount (g) of medium chain triglycerides where added
4.3
Manufacturing process and quality control mechanisms
The ACBS will require evidence that appropriate manufacturing processes
and quality control mechanisms are in place. The applicant must provide
hard copies of current and appropriate external certification which is
recognised by the UK / EC.
If any part of the manufacturing process takes place outside the EU,
companies must provide evidence (hard copy) that manufacturing and
quality standards continue to comply with the relevant UK / EC legislation
and that equivalent manufacturing accreditations and testing methodologies
are in place. See also Appendix 2.
There must also be an absence of pathogenic bacteria in all liquid products,
specifically E Coli and Salmonella. While sterility cannot be guaranteed, all
powdered products must be free from pathogenic E Coli and pathogenic
Salmonella.
The statement below must be signed and dated by an appropriately
competent and authorised individual describing their status and
accepting legal responsibility for the validity of the evidence provided
on behalf of the Applicant.
On behalf of the applicant, I accept legal responsibility for the
accuracy of all the information provided in paragraph 4.3 and
confirm that the application conforms to all legal requirements
Name:
Status:
Signature:
Date:
Note: at least one copy of the application must contain an original signature
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4.4
Special instructions
4.4.1 All powdered products must include a scoop and instructions for
reconstitution either using a specified scoop (which must be included)
for measuring loose powder, or a given weight of powder in a sachet.
The size and weight of powder contained in the scoop must be
stated. There must also be instructions for safe storage after
reconstitution.
Note: The Infant Formula and Follow-on Formula Regulations (2007)
require that instructions are provided for appropriate preparation,
storage and disposal of all infant products.
4.4.2 Standard recipes / baking instructions must be provided if
appropriate. The only type of recipe or usage instruction that could
be included on a product label is that which is relevant to the product
being considered.
4.5
Shelf life
Information must be provided about the maximum length of time after which
the product must not be used.
Directions must also be provided about the product storage conditions in
opened, prepared for use and unopened states.
4.6
Terminology
4.6.1 For a product to be considered “nutritionally complete”, it must be
able to provide the sole source of nourishment (with safe and
appropriate levels of all macro / micronutrients) for each 24 hours for
the person for whom it is intended when used in accordance with the
Applicant’s instructions; no additions will be necessary to maintain
optimal nutritional status.
If an Applicant claims that a product is “nutritionally complete” and
can be used as the sole source of nutrition, the following information
must appear on the product data sheet:
Adults
The UK Dietary Reference Values must be used:
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The Estimated Average Requirement (EAR) for energy for a 19-49
year old male must be stated as a comparator
The Recommended Nutrient Intakes (RNI’s) for protein,
electrolytes, minerals and vitamins for a 19-49 year old male
must be stated as a comparator
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The volume within which the product meets these requirements
and is therefore promoted as being nutritionally complete
(rounded up or down to the nearest 50 ml) must be stated
Children
The UK Dietary Reference Values must be used:
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The EAR’s for energy for the following age ranges must be stated as
a comparator
1-3 years
4-6 years
7-10 years
The RNI’s for protein, electrolytes, minerals and vitamins must be
stated as a comparator with individual reference to the above bandings
The volume within which the product meets these requirements and is
therefore promoted as being nutritionally complete (rounded up or
down to the nearest 50 ml) must be stated.
All products must have an age range suitability identified
Applicants must provide a rationale for the age range given for their
products
Note: For nutritional requirements for infants, refer to Appendix 3
The following additional statements will be viewed by the ACBS as helpful:
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These amounts may need to be modified according to the age and
clinical condition of the patient.
Referral to a dietitian is always recommended when there is any doubt
about an individual patient’s nutritional requirements.
4.6.2 Ingredient listings must use the common name and, where relevant,
the unique identifiers for each substance. These are the regulated
international non-proprietary names (INN) and the Chemical
Abstracts Service (CAS) registry numbers if available. This means
that the full chemical name and not just the trade name must
be given.
5.
EVIDENCE OF CLINICAL EFFICACY (According to Type of application)
Applicants of Type 1 and Type 2 applications are advised that preliminary
advice from the ACBS / a designated representative of the ACBS might be helpful
in order to confirm the Type / categorisation of the product being submitted. No
face to face meetings / telephone conversations will be held with Applicants.
Correspondence must be conducted via e-mail, through the Secretariat. This is to
ensure transparency and a clear audit trail.
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Clinical trials and palatability studies will not, normally, be required for either
gluten free or low protein foods.
Applications for gluten free foods to be considered by the ACBS are not required to
make the case for the efficacy of a gluten free diet in the treatment of Established
Gluten Sensitive Enteropathy.
Applications for gluten free foods to be considered by the ACBS must include a
‘Certificate of Declaration’ confirming the gluten content of the product.
In the event that a submitted product requires specific expertise in order to consider
any or all aspects of it fully, the ACBS will identify and approach a recognised
expert in the field on an ad-hoc basis to inform the deliberations of the Committee.
5.1
Type 1 applications
The minimum information the ACBS will expect to see is given in
Appendices 4 and 5.
The Committee expect that all Type 1 applications will be fully supported
with evidence and will require all of the following:
- two copies only of the detailed reports of completed clinical trials of the
product which demonstrate its therapeutic usefulness in the management of
disease in the community for the indications sought. Trials should conform
to European Regulations on ‘Good Clinical Practice’ for clinical practice and
research.
- PLUS an abstract of the completed clinical trial, which must include full
references to directly relevant papers from peer reviewed journals.
Note: This abstract must be included within each copy of the application,
i.e. a total of six copies
- PLUS full copies of two relevant papers from the peer reviewed journals as
cited within the abstract.
Note: These must be included within each copy of the application, i.e. a
total of six copies
In situations where it can be anticipated that clinical trials are likely to be
incomplete e.g. very rare conditions, advice from the ACBS prior to
submission might be helpful. Correspondence must be conducted via email, through the Secretariat. This is to ensure transparency and a clear
audit trail.
Any evidence of health economic benefits of a product will be welcomed by
the ACBS.
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General statements of support from healthcare professionals will not be
considered by the ACBS.
5.2
Type 2 applications
Details of acceptability information that the ACBS will expect to see is given
in Appendix 5
The Committee expect that all Type 2 applications will be fully supported
with evidence and will require all of the following:
- an abstract describing published clinical trials of any similar products
(which could be considered to be suitable alternatives) demonstrating their
therapeutic usefulness in the management of disease in the community for
the indications sought. This must include full references to directly relevant
papers from peer reviewed journals.
Note: This must be included within each copy of the application, i.e. a total
of six copies
- PLUS full copies of two relevant papers from the peer reviewed journals,
cited above
Note: These must be included within each copy of the application, i.e. a
total of six copies
Any evidence of health economic benefits of a product will be welcomed
by the ACBS.
General statements of support from healthcare professionals will not be
considered by the ACBS.
5.3
Type 3 applications
Details of the information the Committee will expect to see is given in
Appendix 2.1
If several Type 3 changes are requested for the same product, such that the
product is significantly altered, the applicant may be asked to submit a Type
2 application.
The Committee will require the following evidence of efficacy
5.3.1 If the proposed change relates to minor macronutrient content
modification i.e. nitrogen, fat or carbohydrate (or any component of
these), micronutrient content or concentration, the rationale must be
provided and this should be based on clinical studies wherever
possible.
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5.3.2 If the proposed change relates to changes in the corporate strategy,
manufacturing process, ingredient availability, presentation, new
flavours of an approved product, labelling, patient acceptability or
cost, the rationale must be provided.
Note: If the proposed changes relate to any aspect of acceptability,
the guidance in Appendix 5 must be followed.
5.3.3 If compositional changes are in response to either UK / EC
legislation, then this must be referenced.
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5.3.4 If there is a change to the location in which the product, or any
component of the product, is manufactured then the following will be
required:
5.3.4.1
Within the EU – a statement advising of the new location
and confirming that the source of manufacturing has
changed and advising of the new location but that all
existing UK / EC legislation continues to apply.
5.3.4.2
Outside the EU – a statement confirming that
manufacturing and quality standards continue to comply
with the relevant UK / EC legislation and that equivalent
manufacturing accreditations and testing methodologies
are in place will be required. Appropriate external
certification (recognised by the UK / EC authorities) must
also be submitted.
The statement below must be signed and dated by an appropriately
competent and authorised individual describing their status and
accepting legal responsibility for the validity of the evidence provided
on behalf of the Applicant.
On behalf of the applicant, I accept legal responsibility for the
accuracy of all the information provided in paragraph 5.3.4 and
confirm that the application conforms to all legal requirements
Name:
Status:
Signature:
Date:
Note: at least one copy of the application must contain an original signature
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 six copies of the completed Application. Any amendments as
above will, normally, be submitted for Chair’s action. Three copies
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only of the Application should be submitted initially. If the Chair
decides that the Application should go before the full Committee for
discussion, a further three copies of the Application will be required.
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.
Note: for further information refer to the following link:
https://www.gov.uk/government/groups/advisory-committee-onborderline-substances
6.
ADMINISTRATION TO THE PATIENT (Type 1, Type 2 and relevant Type 3
applications)
6.1
Where appropriate, amount, timing and / or frequency of administration for
adults, infants and children must be given.
6.2
Methods and routes of administration must be described i.e. whether for oral
consumption and / or to be administered via a tube.
6.3
Any requirements for reconstitution of the product before administration to
the patient must be stated.
Note: This information should be provided on the packaging (outer/inner), data
sheet and any technical healthcare professional / patient literature.
7.
CONTRA - INDICATIONS AND PRECAUTIONS (Type 1 and Type 2 applications
only)
Details of warnings, contraindications, side effects, potential interactions with
medicines (both general and, if known, specific), adverse reactions and guidance
on clinical monitoring must be given.
Notes: This information must be provided on the data sheet, any technical
healthcare professional / patient literature and, wherever possible, on the label.
Appropriate guidance should be given if the product is not suitable for use by
particular cultures and must be provided on both the data sheet and any other
relevant technical healthcare professional / patient literature. This information
should also appear on the label if possible.
Specific guidance must be provided, if relevant, about the following:
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8.
Use during pregnancy / lactation
Any potential for overdosing
PRESENTATION (Type 1, Type 2 and relevant Type 3 applications)
The following will be required:
8.1 Description of the appearance and form of the product e.g. solid, powder,
liquid, pasta, bread, biscuit
9.
8.2
Whether it will be sold in a bag, bottle, tin, tub etc
8.3
Weight / volume of each unit
8.4
Secondary / cluster package size and weight / number of units
8.5
Whether any additional giving or measuring devices are included. The size /
volume and weight of product per device must be stated
LABELLING, PACKAGING & SAMPLES (Type 1, Type 2 and relevant Type 3
applications)
9.1
Details of labels / packaging or proposed labels / packaging for all unit sizes
for products must be provided, including labelling for secondary / cluster
packaging.
Any changes to existing labelling required for the UK market must be
submitted to the ACBS. Both old and new labels must be included and
identified as such.
The statement below must be signed and dated by an appropriately
competent and authorised individual describing their status and accepting
legal responsibility for the accuracy of this declaration on behalf of the
Applicant.
Statement to confirm all labelling complies with UK / EC regulations
On behalf of the applicant, I confirm that all the labelling complies with the UK
/ EC regulations and accept legal responsibility for the accuracy of this
declaration.
Name:
Status:
Signature:
Date:
Note: at least one copy of the application must contain an original signature
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9.2
Labels provide information and the ACBS want to ensure that the risk of
clinical errors due to inappropriate labelling is minimised. Labels should be
clear enough to maximise safety and understanding for both patients and
healthcare professionals and to enable the prescriber to feel safe.
If the product is a Food for Special Medical Purposes (FSMP), the approved
indication should be very clear and must include the phrase “for the dietary
management of……”.
Products which are not FSMP’s (this includes gluten free foods) must
not carry this phrase.
The ACBS recognises the need to work within the current legislation, but to
optimise clarity the ACBS would like to see the following:
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From a patient safety perspective the ACBS would want to see the
wording ‘For enteral use only’, as opposed to ‘Not for parenteral use’ or
‘Not for intravenous use’.
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In accordance with Food Law, the salt content of the product must be
shown on the label. The ACBS would also like to see the sodium
content (in mmol) included on the label to support safe prescribing.
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Labels should not refer to the fact that the product is ‘Organic’
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Any warning / precautions should be particularly clear and attract
immediate attention
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Clearly contrasting background and text – in colour
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The avoidance of too much information appearing in too small a space
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The avoidance of multi-lingual labelling whenever possible
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A font size / style which will facilitate easy reading
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The use of the stop (•) as the decimal delimiter, rather than the comma
(,). This is the accepted practice in the UK and USA / Canada as well as
being the standard for scientific measurements published in international
journals.
Note: Applicants must provide a sample of “actual size” labels, using a print
resolution equivalent to that which would be expected from a normal print run.
Electronic versions will not be acceptable. If it is not possible to submit an
“actual size” label, then a sample of the product (preferably without the
contents) must be provided. In this situation, i.e. when a sample is being
provided, a readable label must also be submitted within the application.
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10.
DESCRIPTIVE LITERATURE (Type 1, Type 2 and relevant Type 3 applications)
Any literature intended for healthcare professionals and / or patients and available
at the time of application must be provided.
The Food Information Regulations (2014) prohibit any medicinal claims being made
in the labelling or advertising of foods.
Reference must only be made of the condition for which the product has been
approved (the wording must reflect the ACBS approved indication accurately) and
not imply that the product has other characteristics or is free from other substances
which have not been specifically approved by the ACBS.
The wording outlined on the label / packaging of gluten free products submitted for
the indication of ‘established gluten sensitive enteropathy’ must not imply that the
product has other characteristics or is free from substances other than gluten.
11.
PROMOTIONAL POLICY (Type 1, Type 2 and relevant Type 3 applications)
Any ACBS approved products must comply with current UK/ EC food legislation
regarding health claims.
Reference to ACBS approval should only be made in technical information
specifically designed for the advice of healthcare professionals. This includes:
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entries in the BNF, MIMS, Chemist and Druggist
articles in peer reviewed journals
the standard company data sheet
product data sheets on company websites (which must be password
protected)
Any “direct to patient” marketing or advertising material (in either hard copy or
electronic format including social media websites) promoting an ACBS approved
product must not make any reference (express or implied) to (a) ACBS approval; or
(b) the product being available on prescription. Any breach of this provision may
result in the product being recommended for de-listing.
Reference to ‘electronic format’ includes any information contained on company
websites.
12.
MARKET AVAILABILITY (Type 1 and Type 2 applications only)
12.1 Applicants must state the dispensing unit / pack size.
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12.2 Applicants must state what arrangements are in place to enable approved
products to be dispensed by a pharmacist against a prescription.
13.
PRICE TO THE NHS (All applications)
A statement of the proposed total price of the product (i.e. single dispensing unit) to
the NHS must be provided. This must include the NHS list price and any
distribution costs that may be typically charged to dispensers.
Applicants must confirm that the proposed total price of the product is inclusive of
all distribution costs.
Applicants must indicate where they see their product being positioned within the
current list of ACBS approved products.
14.
ACBS MEETINGS (Type 1 and Type 2 applications only)
Applicants of Type 1 and Type 2 applications are advised that it would be in their
interests for a named representative of the Applicant to be available to respond to
any queries that may arise when their product is considered at a meeting of the
ACBS. This will help to ensure that their product application can be expedited
efficiently but requires availability by telephone at the time of the meeting.
It will not be normal practice to invite representatives of the Applicant to attend the
actual meetings of the ACBS. In exceptional circumstances and at the discretion of
the ACBS, an ad-hoc meeting with representatives of the Applicant may be
convened.
15.
PRODUCT APPROVAL (All applications)
The ACBS Secretariat will advise the Applicant whether or not the product has
been given ACBS status.
For products that are not deemed to be FSMP the ACBS Secretariat will not inform
the NHS Business Services Authority to include the product in Part XV of the Drug
Tariff (Borderline Substances) until the applicant informs the ACBS Secretariat that
the product is being brought to market.
Products that are deemed to be FSMP must be notified to the competent authority,
in this case the Healthy Behaviours, Population Health Directorate at the
Department of Health. FSMP products must be notified upon marketing:
notification may also take place before marketing but not after.
A copy of the letter / e-mail from the Population Health Directorate acknowledging
receipt of the notification must be sent to the ACBS Secretariat. The approved
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FSMP product will not be published within Part XV of the Drug Tariff until a copy of
the acknowledgement of the notification has been received by the ACBS
Secretariat.
If the status of the product as a FSMP is disputed by the Population Health
Directorate, the product will not be published within Part XV of the Drug Tariff until
that dispute is resolved. If, as a consequence of the resolution of that dispute,
changes are made to how the product is presented or promoted, the ACBS will
need to review its recommendation of the product.
Products that have been given ACBS status must be launched within 12 months of
the date of the confirmation letter from the Secretariat. Failure to do so may mean
that a new application is required.
The ACBS will not expect to consider a Type 3 application for a product until it has
been launched and included within the Drug Tariff. If, in exceptional circumstances
this is unavoidable, the Applicant must provide a detailed explanation describing
why the requested change was not included within the original application. The
ACBS may accept the explanation and consider the Type 3 application.
If the Type 3 application is rejected, the Applicant could then either re-apply for a
Type 3 change after the product has been brought to market or submit a new
application incorporating the required change, in which case the original approval
would no longer be valid.
16.
DURATION OF ACBS APPROVAL FOR PRODUCTS (All applications)
The ACBS may review a product at any time and may request a re-application.
Products will not automatically be de-listed.
Notes: Product review is necessary to reflect current trends including:



Changes in clinical practice
Changes in marketing direction
The prescriptions issued in respect of individual products over a period of
time
Companies will be advised if their products are due to be reviewed. They will have
the option of providing supplementary information at this time, if they choose to do
so.
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