An agency of the European Union
Draft presentation:
Summary of product
characteristics
What is it and what does it contain?
Olayinka Fasanya
Medical information - Information compliance and consistency
Table of content of this presentation
1. What is the summary of product
characteristics (SmPC)?
2. Where SmPC information can be
found?
3. Which information can be found in
the SmPC?
4. Structure of the information within
the SmPC
5. Essential information for the use of
the medicine
6. Information on the benefits of the
medicine
7. Information on the risks of the
medicine
8. Information for individualised care
9. Pharmaceutical information
10.How is the information in the SmPC
prepared?
11.What is not included in the SmPC?
12.How can you help maintain the best
quality of information?
13.Where to find more information?
Summary of product characteristics2
1.What is the summary of product
characteristics (SmPC)?
• The SmPC is a legal document approved as part of the
marketing authorisation of each medicine
• The SmPC is the basis of information for healthcare professional
on how to use the medicine
• Its information is updated throughout the life-cycle of the
product as new data emerge
Summary of product characteristics3
2. Where SmPC information can be found?
I. Competent authorities’ websites
1. European Medicines Agency
2. National Competent Authorities
II. Medicines compendia or dictionary
III. SmPCs are the main source of
information of:
1. Medical and pharmaceutical references
2. Electronic prescribing support tools
IV. All parts of advertising must comply with
the SmPC
V. The package leaflets are based from
SmPC information
Summary of product characteristics4
3. Which information can be found in the
SmPC?
• Essential information for the use of a medicine
• Qualitative and quantitative information on the benefits and the risks
• Information for individualised care
– Paediatric and elderly population
– Organ impairment, concomitant disease
– Interaction with other medicines
– Genomic factors
– Pregnancy, lactation and fertility
– Composition of the medicine: prevention of hypersensitivity and excipients
with known effects
– Information on specific situations
• Pharmaceutical information
Summary of product characteristics5
4. Structure of the information within the
SmPC
•Information is presented according
to a predefined structure
•Certain information is suitable in
different sections but cross-references
are made to avoid repetitive
information
5. Essential information for the use of the
medicine (1/2)
The therapeutic indication(s) of the medicine is given in section 4.1, in defining
the target disease and the population to benefit from the medicine.
The dose is specified in section 4.2 “Posology and method of administration” for
each indication(s) and each relevant subpopulation (e.g. depending on age,
concomitant disease):
• With information on frequency of intake, influence of food, duration of treatment,
• Advice on dose adjustment (e.g. to optimise the benefits according to patient’s response or
to limit the risk e.g. in relation to drug interactions),
• Additional information on dosing as necessary (e.g. need for dose titration or tapering off,
maximum recommended dose, action to be taken if an intake is missed)
Section 4.2 also informs on the method of administration, which information
can be complemented with special instructions for handling the medicine in
section 6.6.
Summary of product characteristics7
5.Essential information for the use of the
medicine (2/2)
The situations where the medicine must not be used for safety reasons are
outlined in section 4.3 “Contraindications”. They define the patient populations
who must not take the medicine.
Section 4.4 on “Special warnings and precautions for use”provides
information on :
•Risks requiring a precaution for use prior or during treatment (e.g. monitoring)
•Special patient groups that are at increased risk
•Risks to which healthcare professionals need to be alerted to prevent or handle
•occurence
Summary of product characteristics8
6. Information on the benefits of the medicine
Section 5.1 “Pharmacodynamic properties” summarises the benefits
of the medicine in presenting:
– Its mechanism of action
– The main results of the clinical trials supporting the marketing
authorisation
• In giving the main characteristics of the patient population studied
• And presenting the effects qualitatively and quantitatively
– Additional clinically relevant information in special populations:
• In a balanced way (i.e. informing on uncertainties as appropriate)
• Including study results in the paediatric population, even if the product is not (yet)
indicated, to improve the information available on the use of medicine in the
various paediatric populations
Summary of product characteristics9
7. Information on the risks of the medicine
• Section 4.8 “Undesirable effects”provides:
– A summary of safety profile of the medicine informing on the most serious
and/or most frequently occurring adverse reactions,
– A tabulated list of all adverse reactions with their respective frequency
category, presented according to a standard system organ classification
– Information characterising specific adverse reaction which may be useful to
prevent, assess or manage the occurrence of an adverse reaction in clinical
practice.
– information on clinically relevant differences in special population
• Information on a specific risk is also reflected in section 4.4 “Special
warnings and precautions for use” when the risk leads to a
precaution for use or when healthcare professionals have to be warned
of this risk.
Summary of product characteristics10
8. Information for individualised care (1/8)
• The information in the SmPC first addresses the recommendations that
apply to the general population for whom the medicine is indicated.
• Because the characteristics of some subpopulations e.g. age,
concomitant disease, genomic factors,…may demand specificity in the
use of the medicine,
– The SmPC provides dedicated information for these groups of patients when
information is available
– Such information is usually presented under specific subheading within each
relevant section of the SmPC.
Information on the most frequent subpopulations is illustrated in the next slides
Summary of product characteristics11
Paediatric and elderly population (2/8)
Elderly population
• Similarly, information in the elderly population may be presented in
subsections when clinically relevant differences are known e.g. need
for dose adjustment, specific risks, metabolism,…
Paediatric population:
• Children are a specific subpopulation and a difference in the use of the
medicine is common for this group or some subsets. Therefore, the
SmPC requires mandatory information in several section of the SmPC
e.g. sections 4.2
, 4.4, 4.5, 5.1,… to address the appropriate use in
children.
Summary of product characteristics12
Hepatic and renal impairment
•Patients with hepatic or renal impairment may be subject to dose adjustment due
to potentially altered drug metabolism or excretion.
•Information on possible dose adjustment required are provided in section 4.2
and
the differences in pharmacokinetic profile in section 5.2
Organ impairment, concomitant diseases (3/8)
Concomitant diseases
•Related special warnings or precautions for use are presented under subheading
in section 4.4.
•Information on possible dose adjustment required are provided in section 4.2
and contraindications in section 4.3
Summary of product characteristics13
Interaction with other medicinal products and
other forms of interaction (section 4.5) (4/8)
•Interactions with other medicines are presented in section 4.5 and
recommendations on posology adjustment, precautions for use or
contraindications are also reflected in sections 4.2,4.4 or 4.3
respectively, if any
•Information on the interaction with food and drink is provided in
section 4.5 as well as 4.2
if appropriate.
Summary of product characteristics14
Genomic factors (5/8)
• Pharmacogenomics (PGx) is defined as the study of variations of DNA
and RNA characteristics as related to drug response. The knowledge in
this field is ever increasing with the potential to improve the discovery,
development and use of medicines.
• When available and clinically relevant, information regarding specificity
due to pharmacogenomics are presented in the SmPC e.g. indication or
posology, dose adjustment, contraindication, safety information
Summary of product characteristics15
Pregnancy, lactation and fertility (section 4.6)
(6/8)
Pregnancy and lactation
Section 4.6 provides available information regarding the use of the drug during pregnancy and
recommendations on the use or not of the medicine during pregnancy. Recommendation on
the need to stop or continue breastfeeding while on the medicine is also provided.
Need for contraception
In case of a need of contraception during and/or after treatment, the information will be
provided along with the rationale behind the recommendation
Fertility
When there is a possible effect of the drug on male and female fertility, clinical data if available
as well as relevant conclusions are provided
Related warning may also
be included in section 4.4
Summary of product characteristics16
Composition of the medicine: prevention of
hypersensitivity and excipients with known
effects (7/8)
Hypersensitivity reactions due to the content of the medicine are
handled in the SmPC by:
• Explicitly listing the composition of the medicine i.e. active ingredients
and all excipients in section 6.1
• Highlighting the excipients with known effects in sections 2 and 4.4 with
a description of their risk
• Providing information on possible residues that could be present in the
medicine in sections 2
, 4.3, 4.4 and 4.8 with the appropriate related
information
Summary of product characteristics17
Information on specific situations (8/8)
Effects on ability to drive and use machines (section 4.7)
• Based on the safety profile of the drug, information on the influence of the medicine on the
ability to drive and use machine is provided and depending on the level of influence,
appropriate warnings for use will also be provided in section 4.4
Overdose (section 4.9)
• In case of overdose, section 4.9 provides information on the symptoms and description of
the management
Summary of product characteristics18
9. Pharmaceutical information
In addition to the clinical and pharmacological information, the SmPC
also provides pharmaceutical information:
• Incompatibilities, section 6.2
– Provides information on physical and chemical incompatibilities of the medicine and
the products with which the medicine is likely to be co-administered with
• Shelf life, section 6.3
– Information on shelf life as packaged and if appropriate, information on shelf life after
reconstitution is given
•Precautions for storage, disposal and handling, section 6.4 and 6.6 respectively
– Brief explanation on the recommended storage conditions and the measures to take in
regards to the disposal or handling of the medicine e.g. reconstitution
Summary of product characteristics19
10. How is the information prepared?
Development by the
pharmaceutical
industry
Dossier of
the
medicine
with
proposed
SmPC
Dossier of
the
medicine
with
proposed
SmPC
Submission to the Medicine
Competent Authority
• Drug discovery
• Preclinical trials
• Clinical trials
According to international
guidelines
• Assessment of quality, safety
and efficacy
•Input from stakeholders
•Evaluate how the SmPC will
optimise the benefits and
manage the risks according to
the SmPC guideline
Approval of the medicine
Approved SmPC
•New clinical trials
•Reporting of adverse reactions
•Epidemiological data
Data collected after approval of the medicine
will be included in the dossier and assessed by
the Competent authority; the SmPC is updated
accordingly
Post-marketing experience
Summary of product characteristics20
11. What is not included in the SmPC?
• Detailed information on the scientific development which is available in
the public assessment report
• Information in non-approved indication
– Because the MAH has not claimed the indication
– An indication has been claimed but data did not demonstrate a positive benefit
risk of the medicine; withdrawal or refusal AR provide available data.
– Exception in the paediatric group; the Paediatric Regulation aims to improve
the information regarding this subgroup by providing all information on
clinically relevant trials
• Specific issue for which data is lacking
• General advice on the treatment of particular medical conditions
Summary of product characteristics21
12. How can you help maintain the best
quality of information?
• The SmPC is a living document that requires update when new
relevant information emerges e.g.:
– New adverse reactions observed after marketing of the product reported to
the national competent authorities or the company
– Following safety communication updates
• The new European pharmacovigilance legislation encourages
participation of patients and healthcare professionals in reporting
suspected adverse reactions
