ABBREVIATED SUBMISSION FORM AND GUIDANCE
Introduction
1. The abbreviated submission process allows SMC to honour its published remit and track all
products. SMC will issue advice on all new chemical entities (or new active substances) and all
new indications for established products through the full submission process.
2.
An abbreviated submission may be appropriate for new formulations of established products.
3. An abbreviated submission may be appropriate for some medicines indicated for use in children
or adolescents, where SMC/Health Improvement Scotland (HIS) has previously accepted the
medicine for use in adults for the same indication or the indication in adults predates SMC
establishment (31 January 2002). Manufacturers should seek confirmation from the SMC
secretariat that an abbreviated submission is appropriate in these circumstances,
4. An abbreviated submission should be made when a manufacturer considers that a full submission
is not required.
5. The abbreviated process requires manufacturers to complete and submit an Abbreviated
Submission Form. The form and Guidance Notes are on the SMC website. If the manufacturer is
in doubt about the submission process to be followed, guidance should be sought from the SMC
Secretariat (contact details below).
6. Examples of products that may be suitable for an abbreviated submission are given below. A key
consideration is the product’s likely impact on budgets and resource allocation across NHS
Scotland. If a product could potentially have a significant budget impact, a full submission should
be made. Guidance can be sought from the SMC Secretariat (contact details below).
7. SMC reserves the right to request a full submission in relation to any product in the event that it is
anticipated to have an impact on NHS Scotland resources which has not been fully taken into
account by the submitting company. The decision of the SMC in this respect is final and binding.
Product marketing authorisation for :
Type of submission
required:
1.
New active substance – even if the number of potential
patients is small and the expected budget impact is low
Full
2.
Additional indication / licence extension approved by the
MHRA/EMA - even if the number of potential patients is
small and the expected budget impact is low
Full
3.
Biosimilar medicine where the reference product is not
recommended by SMC/HIS for the same indication(s)
and in the same population
Full
4.
New formulation (e.g. slow release presentation, liquid)
at more than pro rata cost relative to existing therapy
Please consult the SMC
secretariat for advice on
submission requirements once
final details of product pricing
are available.
5.
New formulation (e.g. slow release presentation, liquid)
at pro rata cost or less relative to existing therapy –
similar clinical effectiveness must be capable of being
demonstrated briefly, in simple terms
Abbreviated
6.
Combination products of established medicines
7.
Licensed preparation of an established unlicensed
preparation
8.
Marketing authorisation for medicine has been extended
for use in children or adolescents, where product has
previously been accepted by SMC in the same
indication for use in adults or indication in adults
predates SMC establishment (31 January 2002)
Please consult the SMC
secretariat for advice on
submission requirements once
final details of product pricing
are available.
Please consult the SMC
secretariat for advice on
submission requirements once
final details of product pricing
are available.
Abbreviated submission may
be appropriate. Seek guidance
from secretariat.
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ABBREVIATED SUBMISSION FORM
Company name and address
Company contact name and
contact details
Date submitted
1. Registration details
Drug (generic and trade name)
Formulation, strength(s), route of administration
Full licensed indication as described in the summary of product characteristics
If the submission is not for the full licensed indication please state clearly any
positioning you wish SMC to consider
Dose
Regulatory authority and status
Launch or product availability date in UK
Licensing / anticipated date of marketing authorisation in UK (including web links
where available)
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2. Product and background information to support an abbreviated submission
1. Provide the basis for the submission and justification for applying via the
abbreviated route.
First branded generic
a new formulation of an existing medicine which costs the same or less
a new formulation of an existing medicine with small cost premium and
limited budget impact
new combination preparation of existing medicines which costs the same
or less
new combination preparation of existing medicines with small cost
premium but limited budget impact
licensed preparation of an established unlicensed preparation which
costs the same or less or has a small cost premium and limited budget
impact
new licence extension for children or adolescents
other please state...............................................................................
2. Provide background details for the product plus web links where appropriate in
relation to regulatory information (eg product or reference/parent product).
3. Provide details of existing therapy in particular what therapy(ies) may be replaced
in Scottish practice, if this differs from the reference/parent product.
4. Provide details of previous SMC advice for any parent/reference product,
alternative formulation or existing therapy if applicable.
5. Provide a brief demonstration of similar clinical effectiveness or where appropriate
bioequivalence to a reference product/parent preparation or non inferiority to
existing therapy.
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6. Please supply the acquisition cost for the medicine and existing therapy in the
cost table below. Other associated costs should not be included.
Medicine
Formulation
Dose
Cost per
unit/course/
month/year*
*Complete as appropriate
7. If you consider that this product may be appropriate for an abbreviated submission
but the acquisition cost of the product, as detailed in the table above, is more than
the reference/parent compound or existing therapy:

Describe any additional benefits in simple terms that might justify this cost
premium eg preservative-free, liquid formulation. A cost premium that
requires analysis of benefit is likely to require a full submission.

Please estimate any net budget impact with reference to medicine costs
only eg small or medium impact [<£100,000 or ≥£100,000 per annum].
8. Has this medicine previously been associated with a Patient Access Scheme (PAS)
for a different formulation or indication? Will this same PAS be available for this
new formulation/indication?
9. Please provide any information specific to this product and relevant to the review
that may not be covered by other sections of this form.

Please supply the most recent updated or draft Summary of Product
Characteristics
Signature
Print Name
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Date
GUIDANCE ON COMPLETION OF ABBREVIATED SUBMISSION FORM
Company name and
address
Including postal address
Company contact name
and contact details
Name of person to contact in the event of questions with telephone and
e-mail details
Drug (generic and trade
name)
Full approved name and brand name of product
Formulation, strength
If relevant, details of new formulation including strength
Full licensed
indication(s)
Details of approved indications from the product licence as detailed in
the Summary of Product Characteristics
Positioning
Detail any proposed positioning within the licensed indication that SMC
is requested to consider e.g. subpopulation of the licensed indication,
only part of the licensed indication.
Does the new product have a marketing authorisation? If yes, specify
date approved, including regulatory authority. If no, specify anticipated
date of approval.
Regulatory authority and
status
Launch or product
availability date
Actual date if launched (or the date the product became available to the
market), otherwise anticipated launch date.
Branded generic
Refer to SMC statement on branded generics
[www.scottishmedicines.org.uk/About_SMC/Policy_Statements/Generic
_Medicines]
Combination preparation
A preparation that includes two or more active ingredients combined in
a single dosage form.
Previous SMC advice
Provide relevant SMC advice for any previous licensed indications for
the medicine, for any relevant reference or existing medicines.
Brief demonstration of
similar clinical
effectiveness.
This should include the following:
 the basis of assumption for similar effectiveness should be stated.
 a comparison of price per treatment, or per day, or per equivalent
dose should be stated.
Cost table
Costs supplied in the cost table should be list price of the relevant
medicine(s). All relevant compounds should be included. Costs should
be medicine acquisition costs only and should not include any other
associated costs.
Budget impact
If the product is to be considered for an abbreviated submission but it
has a cost premium compared with existing therapy then section 7
should be completed. The costs should only include the acquisition cost
of the product and should not include any other associated costs.
Patient Access Scheme
(PAS)
A PAS is a scheme proposed by a pharmaceutical company in order to
improve the cost-effectiveness of a medicine and enable patients to
receive access to cost-effective innovative medicines.
Signature, name, date
Of person submitting the form, and date of submission
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Notes
1.
In order that SMC can meet its remit of advising on new products as close as possible to the
product being available for use in NHS Scotland, abbreviated submission forms should be
sent to the SMC Secretariat ideally 3-4 months before the product is anticipated to become
available. An electronic submission, in the form of a word document, is the preferred route
accompanied by a Summary of Product Characteristics (SPC). Please email the completed
form to [email protected] and [email protected]
2.
SMC reserves the right to request a full submission in relation to any product in the event that
it is anticipated to have an impact on NHS Scotland resources which has not been fully taken
into account by the submitting company. The decision of the SMC in this respect is final and
binding.
3.
Abbreviated submissions will be considered by the New Drugs Committee (NDC) and the
Scottish Medicines Consortium (SMC), in the same timeframe as a full submission. SMC
advice in relation to abbreviated submissions will be published on the SMC website.
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