ADVISORY COMMITTEE ON BORDERLINE SUBSTANCES
INFORMATION NOTES / APPLICATION FOR A DERMATOLOGICAL PRODUCT TO BE CONSIDERED BY THE ACBS
- 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 brief supporting evidence
- Applicants must conform to this format and layout
- All information must be provided in English
- Applications, including Type 3 applications, which do not conform to the above requirements, WILL NOT be accepted
- 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.
1. CATEGORISATION OF DERMATOLOGICAL PRODUCTS (All applications)
See Appendix 1 for further information
NOTE: Many emollient (moisturiser) products, cleansing agents and other
similar products are readily available and some have product licences. Such
products will not, therefore, normally be considered by the ACBS.
Category 1General dermatology products
Category 2Sunscreens
Category 3Camouflage cosmetics
Note: While a degree of choice of all the above items may be important to
facilitate compliance, it isnot intended that an infinite variety of broadly similar
products should be available on prescription at NHS expense. Other factors being
equal, normally total price to the NHS 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 categorisation of the product beingsubmitted. 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 1New formulations which the Applicant perceives to have well characterised and substantiatedadvantages in terms of dermatological composition and patient tolerance / acceptability
Type 2Formulations which are broadly similar in composition to existing products already on themarket 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 3Existing products to which minor changes (including price) are proposed.
3.PRODUCT STATUS
3.1MedicinesAct (Type 1, Type 2 and relevant Type 3 applications)
A statement of exemption from the licensing and other provisions of the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994 or the Medicines Act 1968 and associated legislation must be obtained prior to any submission to the Advisory Committee on Borderline Substances by writing to 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.
NOTES: 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.
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 applications is found, the ACBS will advise the MHRA
who may then require a complete re-submission to confirm the original
certification.
Details for Type 3 changes, as listed below, must also be sent to the
MHRAvia their on-line ACBS form. A copy of the resulting MHRA
response must beincluded within the Type 3 application:
- 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.
3.2Cosmetics Regulation (Type1, Type 2 and relevant Type 3 applications)
As these products are considered to be cosmetic products, they must also comply with the European Regulation on Cosmetic Products (Regulation (EC)1223/2009)which will replace the existing Cosmetics Directive (76/768/EEC) by 2013.
Note:If any particular claims are made in respect of an individual product,
then all the necessary data must be provided.
4. FORMULATION (Type 1, Type 2 and relevant Type 3 applications)
4.1Ingredients and dermatological information
4.1.1A complete quantitative formulation must also be provided together with confirmation that these comply with all the relevant UK / EC legislation (see Appendix 3).
4.1.2A data sheet about the product must also be provided. 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 be shown.
4.1.3A statement must be provided, signed and dated by an appropriately competent and authorised individual describing their status and accepting legal responsibility for the accuracy of all the above declarations on behalf of the Applicant.
4.2Dermatological composition
The following information must be provided in addition:
4.2.1 General dermatology products
4.2.1.1The complete composition of the product must be given in terms of the actual amounts in the finished product.
Note: Emollients (moisturisers), cleansing agents and other
similar products which are readily available to the consumer on
the retail market will not be considered for ACBS approval
unless there is a well-characterised therapeutic use which is not
availablefrom medicinal products with a product licence or from
BP preparations.
4.2.1.2The types / amounts of any penetration enhancing agents.
4.2.2Sunscreens
4.2.2.1Thecomplete composition of the product must be given in terms of the actual amounts in the finished product.
4.2.3 Camouflage cosmetics
4.2.3.1The complete composition of the product must be given in
terms of the actual amounts in the finished product.
4.3Manufacturing process and quality control mechanisms
A full manufacturing statement must be provided with reference to appropriate external certification which is recognised by the UK / EC. This statement 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.
Note:If any part of the manufacturing process takes place outside the EU,
companies must confirm that manufacturing and quality standards continue to
comply with the relevant UK / EClegislation and that equivalent manufacturing
accreditations and testing methodologies are in place. See also Appendix 2.
4.4Special instructions
4.4.1All products
Evidence must be provided to demonstrate patient tolerance of the complete formulation.
4.4.2General dermatology products
There are no special instructions for skin preparations.
Note:Emollients (moisturisers), cleansing agents and other similar
products which are readily availableto the consumer on the retail
market will not be considered by the ACBS unless there is a well-
characterised therapeutic use which is not available from medicinal
products with a product licenceor from BP preparations.
4.4.3Sunscreens
4.4.3.1These will only be recommended for the photo-protection of skin in patients who have been formally diagnosed with abnormal photo-sensitivity.
4.4.3.2The indications for recommended sunscreens will be for “protection from UV radiation in abnormal cutaneous photosensitivity resulting from genetic or acquired disorders”.
4.4.3.3Only products with an appropriately assessed UVB SPF of 30 or more together with an appropriately related UVA protection will be considered by the ACBS for approval.
4.4.3.4Sunscreens must comply with the EC Directive (SCC/803-5/90) on the safety of UV filters. Only those UV filters specifically approved for use and listed in the appropriate annex to the Cosmetics Regulation EC 1223/2009 may be used.
4.4.3.5The ACBS wishes to encourage the use of sunscreens that provide significant protection against UVA. COLIPA recommendations and those of the European Commission should be followed.
Note: See Appendix 3 for references
4.4.3.6 The ACBS will wish to see evidence of UVB SPF testing using the international harmonised methods.
Note: See Appendix 3 for details of references.
4.4.3.7If water resistance is claimed, COLIPA recommendations should be followed.
Note: See Appendix 3 for details of references.
4.4.4Camouflage cosmetics
There are no special instructions for CamouflageCosmetics.
4.5Shelf life
Information must be provided about the maximum length of time after which the product must not be used. The shelf life may be indicated as the period after opening (PAO) rather than in the form of an expiry date.
Directions must also be provided about the product storage conditions in opened, prepared for use (if relevant) and unopened states.
4.6Terminology
4.6.1Nomenclature
Ingredient listings must use the INCI (International Nomenclature of Cosmetic Ingredients). This means that the trade name alone is insufficient. In the case of an ingredient being in the form of a mixture, the separate components of that mixture must be indicated by their INCI name.
5.EVIDENCE OF CLINICAL EFFICACY (According to type of application)
Notes: Applicants of Type 1 and Type 2 applications are advised that preliminary
discussion with the ACBS/ a designated representative of the ACBS might be helpful
in order to confirm the 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.
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.
5.1Type 1 applications
5.1.1 General Dermatology Products
Ifthere is a well characterised therapeutic use, which is not available from medicinal products or BP preparations, then this will requireadetailed report ofall completed clinical trialsundertaken withthe productto investigate its therapeutic usefulness in the management of the disease in the community for the indication(s) sought. Guidance about the minimum information the ACBS will expect is given in Appendix 4 to these Notes of Guidance.
Note:Emollients (moisturisers), cleansing agents and other similar
products which are readily available to the consumer on the retail
market, will not be considered for ACBS approval unless there is a well-
characterised therapeutic use which is not available from medicinal
products with a product licence or from BP preparations.
5.1.2Sunscreens
These will not require a therapeutic trial.
5.1.3CamouflageCosmetics
These will not require a therapeutic trial.
5.2Type 2 applications
These will require evidence from any available studies of products which are broadly similar in composition (and which could be considered to be suitable alternatives) demonstrating their therapeutic usefulness in the management of dermatological conditions in the community for the indications sought.
Note: Thisrequirement will only apply to those products having a well-
characterised therapeutic use which is not available from medicinal products
or BP preparations (see para. 5.1.1).
5.3Type 3 applications will require the following evidence of efficacy:
5.3.1 if the proposed change relates to concentration, the rationale must be provided and this should be based on studies carried out in human subjects wherever possible;
5.3.2if the proposed change relates to changes in the corporate strategy, manufacturing process, ingredient availability, presentation, labelling, patient acceptability or cost, the rationale must be provided.
Note: If the proposed changes relate to any aspect of acceptability
these must be fully explained and supported.
5.3.3If compositional changes are in response to either UK / EC legislation, then this must be referenced.
5.3.4If 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:
5.3.4.1Within 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;
5.3.4.2Outside 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 UK / EC authorities) must also be submitted.
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. Any amendments as above will, normally, be submitted for Chairman’s action. Three copies onlyof the Application should be submitted initially. If the Chairman decides that the Application should go before the full Committee for discussion, a further sixteen 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.
For further information about Type 3 changes, please refer to Appendix 2.1.
- ADMINISTRATION TO THE PATIENT (Type 1, Type 2 and relevantType 3 applications)
6.1Where appropriate, dosage, timing and / or frequency of application for adults, infants and children must be given.
6.2Methods of application must be described.
6.3Any requirements for dilution / modification of the product before application to the patient must be stated.
Note: This information should be provided on the packaging, data sheet and
any technical healthcare professional / patient literature.
7.CONTRA - INDICATIONS AND PRECAUTIONS (Type 1 + Type 2 applications only)
Details of warnings, contraindications, side effects, potential interactions with medicines (both general and, if known, specific), compatibilities, adverse reactions and guidance on clinical monitoring must be given.
Notes:This information must be provided on both the data sheet and any technical
healthcare professional / patient literature.
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:
- use during pregnancy / lactation
- any potential for over – application
- PRESENTATION (Type 1, Type 2 and relevant Type 3 applications)
The following will be required:
8.1Description of the appearance and form of the product;
8.2Whether it will be sold in a tube, bottle, tub, aerosol etc;
8.3Weight / volume of each unit;
8.4Secondary / cluster package size and weight / number of units.
Note: This information can be provided on the data sheet.
9.LABELLING, PACKAGING & SAMPLES (Type 1, Type 2 and relevant Type 3 applications)
9.1Details 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. A statement must be provided confirming that all labelling complies with UK / EC regulations. This statement 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.
9.2Labels provide information and the ACBS wants 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. The ACBS recognises the need to work within the current legislation and appreciates that further direction about this will, eventually, be issued by the EC. In the meantime to optimise clarity, the ACBS would like to see the following:
- any warning / precautions should be particularly clear and attract immediate attention
- the precise indication approved by the ACBS should appear on the label
- clearly contrasting background and text
- the avoidance of too much information appearing in too small a space
- the avoidance of multi-lingual labelling, whenever possible
- a font size / style which will facilitate easy reading
- that any necessary legal information should conform with the above.
Note: Applicants must provide a sample of ‘actual size’ labels, using a print
resolution equating to that which would be expected from a normal print run. Electronic versions will not be acceptable. If it is notpossible to submit an “actual size” label, then a sample of the product(preferably without the contents) must beprovided.
9.3Applications for sunscreen products must show the protection factors on the product container as well as on any other packaging materials. The container must also carry recommendations for frequent application during exposure to the sun. Guidance on the frequency of re-application following water immersion must also be given on the container.
9.4Labelling and promotional materials must not refer to “safe tanning”.
10.DESCRIPTIVE LITERATURE (Type 1, Type 2 applications and relevant Type 3 applications)
Any literature intended for patients and available at the time of application must be
provided.
Reference must only be made to 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 which have not been specifically
approved by the ACBS.
Labelling and any promotional materials must not include any claims about cosmetic
benefits or suggest suitability for use by particular groups of thepopulation.
Examples of this type of cosmetic prose are listed below. This is intended as an
indicative, but not an exhaustive list.
- fragrance free
- paraben free
- lanolin free
- dermatology tested / approved
- non comedogenic
- tested on sensitive skin
- Hypoallergenic
11.PROMOTIONAL POLICY (Type 1, Type 2 and relevant Type 3 applications)
A statement must be provided about present and / or proposed promotional policy, i.e. whether the product will be advertised solely to healthcareprofessionals or whether the products will also be promoted to the general public.