REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Text with EEA relevance)
Date: 2017-03-22
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer information, drug surveillance, labelling, market approval, marketing standard, medicinal product

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 22.3.2017  COM(2017) 135 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use   (Text with EEA relevance)  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament 
and of the Council of 6 November 2001 on the Community code relating to medicinal 
products for human use 

(Text with EEA relevance) 

1. 

INTRODUCTION 
This report is prepared pursuant to Article 59(4) of Directive 2001/83/EC1 according 
to which the Commission shall present to the European Parliament and the Council 
an  assessment  report  on  current  shortcomings  in  the  summary  of  product 
characteristics  and the package leaflet and how they could be improved in  order to 
better meet the needs of patients and healthcare professionals.2  

2. 

REGULATORY FRAMEWORK 

The summary of product characteristics (SmPC) the content of which is described in 
Article 11 of Directive 2001/83/EC and the package leaflet (PL) the content of which 
is described in Article 59 of Directive 2001/83/EC form an intrinsic and integral part 
of  the  marketing  authorisation  for  medicinal  products  in  the  Union  in  accordance 
with Article 6 of Directive 2001/83/EC and Article 3 of Regulation (EC) 726/20043. 

Article  8(3)(j)  of  Directive  2001/83/EC  and  Article  6(1)  of  Regulation  (EC) 
726/2004 require that, in order to obtain a marketing authorisation, a SmPC and a PL 
must be included in the marketing authorisation application. 

1 

2 

3  

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use. 
This is a first Commission report under Article 59(4) of Directive 2001/83/EC. The initial deadline for 
submission of the report was 1 January 2013, but it was delayed due to the need to obtain additional 
evidence through an external expert study, to consult the Member States on the outcomes of the external 
study and to analyse the input received. 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1. 

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Detailed  guidance  on  the  correct  implementation  of  the  abovementioned  legal 
requirements is provided in the regulatory guidelines, in particular:  
Guideline on Summary of Product Characteristics ("SmPC Guideline")4;  

Guideline  on  the  packaging  information  of  medical  products  for  human  use 
authorised by the community ("Packaging Information Guideline")5;  

Guideline  on  the  readability  of  the  labelling  and  package  leaflet  of  medicinal 
products for human use ("Readability Guideline")6.  

Further  practical  guidance  can  be  found  in  the  templates  of  the  Quality  Review  of 
Documents  group  (QRD  templates).7  The  QRD  templates  provide  the  official 
wording to be used in the SmPC and PL in accordance with Directive 2001/83/EC. 
The aim of the QRD templates is to achieve consistency across different medicinal 
products  and  across  all  Member  States.  The  templates  define  standard  headings, 
standard statements and terms and the format and layout to be used.  

When  the  marketing  authorisation  is  issued  by  the  competent  authorities  of  the 
Member States, the Marketing Authorisation Holder shall be informed of the SmPC 
as approved by them8 and the national competent authority concerned shall, without 
delay, make publicly available the marketing authorisation together with the package 
leaflet  and  the  summary  of  product  characteristics.9  For  decisions  concerning 
centralised marketing authorisations, according to Article 10 of Regulation (EC) No 
726/2004, the final Commission decision with the SmPC and the PL is addressed and 
notified to the Marketing Authorisation Holder. 

After a marketing authorisation has been granted the content of the SmPC cannot be 
changed  except  with  the  approval  of  the  competent  authority  that  granted  the 
marketing  authorisation.  The  SmPC  is  the  basis  of  information  for  healthcare 
professionals on how to use the medicinal product safely and effectively. It is not in 
the remit of the SmPC to give general advice on the treatment of particular medical 
conditions. On the other hand specific aspects of the treatment related to use of the 
medicinal product or its effects should be mentioned in the SmPC. Similarly, general 
advice on administration procedures should not be included but any advice specific 
to the concerned medicinal product should be included.10 

The  PL  provides  a  set  of  comprehensible  information  enabling  the  use  of  the 
medicinal product safely and appropriately. The package leaflet is primarily intended 
for the patient/user. If the package leaflet is well designed and clearly worded, this 
maximises  the  number  of  people  who  can  use  the  information,  including  older 
children and adolescents, elderly, those with poor literacy skills and those with some 
degree of sight loss.11 

4 
5 
6 
7 

8 
9 
10 
11 

information 

is  available  at 

http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf  
http://ec.europa.eu/health/files/eudralex/vol-2/c/bluebox_06_2013_en.pdf  
http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf  
the  European  Medicines  Agency: 
the  QRD  website  of 
More 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_00
0134.jsp  
Article 21(2) of Directive 2001/83/EC. 
Article 21(3) of Directive 2001/83/EC. 
For more details see the Commission Guideline on the Summary of Product Characteristics. 
For more information see the Commission Guideline on the Readability of the Labelling and Package 
Leaflet of Medicinal Products for Human Use.  

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3. 

ASSESSMENT 

The  Commission  engaged  external  contractors  to  produce  two  studies  in  order  to 
provide  supporting  information  for  this  report.  Details  of  these  two  studies  are 
provided below.  

3.1. 

Study on the Package Leaflets and the Summaries of Product Characteristics of 
Medicinal Products for Human use ("PIL-S Study")12  

The study has been carried out by NIVEL (Netherlands Institute for Health Services 
Research) together with the University of Leeds.  

The objective of this study was to provide the European Commission with: 

an  assessment  of  the readability  and  comprehensibility  of  the  SmPC  and  the  PL  as 
sources  of  information  on  prescription  and  non-prescription  medicines  for  patients 
and healthcare professionals; 

an assessment of the causes and (potential) consequences of identified shortcomings, 
and 

recommendations for improvement of the SmPC and the PL of prescription and non-
prescription medicines based on this assessment. 

The assessment included an extensive literature search, a European-wide stakeholder 
survey (including representatives of patients and consumers organisations, healthcare 
professionals,  pharmaceutical  industry  and  entities  engaged  in  user  testing)  and  an 
online discussion forum. 

3.2. 

Study on the feasibility and the value of a possible “key information section” in 
patient  information  leaflets  and  summaries  of  product  characteristics  of 
medicinal products for human use ("PILS-BOX Study")13  

Also this study has been carried out by NIVEL and the University of Leeds. 

The objectives of the PILS-BOX study were: 

to  collect  existing  evidence  on  the  potential  impact  of  adding  a  key  information 
section on the safety and efficacy of medicines’ use; 

to assess the feasibility of adding a key information section in the context of the EU 
legislation; 

to assess the potential cost/efficacy of adding key information in the context of the 
EU legislation. 

The assessment included an extensive literature search, a European-wide stakeholder 
consultation and an analysis of the Strengths, Weaknesses, Opportunities and Threats 
(SWOT analysis). 

3.3. 

Input from stakeholders and Member States 

As part of the two studies a European-wide stakeholder survey has been conducted in 
which the key stakeholders were asked to provide their views on existing strengths 

12 

13 

The  study  was  produced  and  funded  under  the  EU  Health  Programme  (2008-2013)  under  the 
Framework Contract N°EAHC/2010/Health/01.  

Also  this  study  was  produced  and  funded  under  the  EU  Health  Programme  (2008-2013)  under  the 
Framework Contract N°EAHC/2010/Health/01.   

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and  shortcomings  of  the  SmPC  and  PL.  The  results  of  the  survey  have  been  taken 
into account in the conclusions of both studies and also in this report.  

Once  finalised  the  two  external  studies  have  been  published  on  the  Commission 
website14 and submitted for consultation to the Member States in the framework of 
the  Pharmaceutical  Committee.  The  Member  States  comments  have  been 
summarised  in  a  document  published  on  the  Commission  website15  and  duly  taken 
into account in this report. 

The European Medicines Agency services collaborated closely with the Commission 
in  the  course  of  preparations  of  this  report  and provided  valuable input  related,  for 
example,  to  the  activities  of  the  Working  Group  on  Quality  Review  of  Documents 
(QRD) and other areas of Agency's expertise. 

4. 

OUTCOMES AND RECOMMENDATIONS 

Based  on 
recommendations have been identified.  

the  above  mentioned  assessment 

the  following  outcomes  and 

It  has  been  generally  considered  that  the  current  EU  legislation  on  medicinal 
products  for  human  use  allows  for  enhancement  of  the  statutory  medicines 
information  to  support the safe and effective use of medicinal products. The below 
recommendations should be, therefore, primarily taken forward by improvements of 
the existing regulatory guidelines, templates and other non-legislative means. 

4.1. 

Room for improvement of PL rather than of SmPC 

As far as the PL is concerned, patient’s comprehension of the PL and its readability 
can be improved. The language used is often too complex and the design and lay-out 
are  not  always  user-friendly.  The  elderly  and  those  with  low  literate  skills  are 
particularly disadvantaged, but generally these problems hold for all patient groups. 

On the other hand, less problems were identified with regard to the SmPC although 
improvements  can  still  be  made  especially  with  regard  to  the  readability  of  the 
SmPC. Representatives of healthcare professionals generally judge the quality of the 
SmPC as reasonable and value most of the current topics addressed in the SmPC as 
being important. 

Recommendation:  Generally,  there  should  be  more  focus  on  improving  the  PL 
rather than the SmPC. However, for any potential improvement of the PL it should 
be also considered whether a corresponding or related change of the SmPC would be 
appropriate. 

4.2. 

Amendments of Guidelines and QRD templates to enhance readability of PL 

Content  and  layout-related  issues  have  been  identified  in  the  PIL-S  Study.  It  is 
considered  that  future  work  on  guidelines  relating  to  the  PL,  and  possibly  also  the 
SmPC to some extent, has the potential to solve a number of these issues.  

Guidelines should include more details on the principles of good information design 
in  which  content  and  layout  are  jointly  considered.  This  would  help  to  ensure 
compliance  with  the  legal  requirement  that  the  PL  shall  be  "clearly  legible". 

14 

15 

http://ec.europa.eu/health/files/committee/75meeting/pil_s.pdf and 
http://ec.europa.eu/health/files/committee/75meeting/pilbx.pdf  
http://ec.europa.eu/health/files/committee/75meeting/pharm699_6a_pil_and_smpc_doc.pdf  

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Moreover improvements related to the language used would help to ensure that the 
information is "clear and understandable" as also required by the legislation. 

These  issues  could  be  best  addressed  by  improving  the  existing  guidelines,  in 
particular  the  Readability  Guideline,  the  Packaging  Information  Guideline  and, 
where appropriate, the SmPC Guideline. The relevance and importance of the QRD 
template  is  also  acknowledged  in  this  respect  as  it  is  the  main  tool  to  provide 
guidance  to  the  industry  in  a  harmonised  way.  The  QRD  template  should  rely  on 
principles  of  good  information  design  and  pay  attention  also  to  the  needs  of  some 
specific  groups  of  patients,  such  as  elderly,  young  people  or  people  with  mental 
illnesses. 

Small font size, narrow line spacing and the length of the PL were identified as the 
main issues.  

Guidelines and QRD templates are also considered too restrictive in some respects. 
They  should  allow  for  more  flexibility  to  adapt  the  PL  to  the  specificities  of  each 
product  whilst  respecting  the  limits  provided  by  the  legislation.  Deletion  of  some 
information  that  is  currently  required  by  the  QRD  template  but  that  is  of  limited 
relevance  for  patients  may  allow  more  space  to  improve  the  content  and  layout  of 
package leaflets and should, therefore, be considered.  

More attention should be also paid to the translation of the user-tested PL into other 
languages. It is considered important to keep the ‘lay-ness’ of the user-tested version 
when the leaflet is translated. 

Recommendation:  It  should  be  considered  to  revise  the  existing  guidelines,  in 
particular  the  Readability  Guideline,  the  Packaging  Information  Guideline  and, 
where  appropriate,  the  SmPC  Guideline  to  include  principles  of  good  information 
design and consider allowing more flexibility in the information recommended in the 
QRD  template,  as  long  as  the  relevant  legislation  allows  it.  These  revisions  should 
also include introduction of guidance on translations that go beyond the principle of 
faithful  translation.  The  aim  should  be  to  ensure  that  the  lay  language  introduced 
through user testing in the original language version is not lost during translation. 

4.3. 

Improving patient input in developing and testing of PLs  

The assessment recognised the usefulness of patient involvement and the importance 
of user testing of the PL. It is equally important that methodology for such testing is 
well defined. The assessment further identified the need for strengthening the input 
from the patient perspective which could also help in getting more understanding on 
how to present risk-benefit information for a particular medicine. 

Recommendation:  The  input  from  patients  during  the  process  and  the  related 
methodology  should  be  further  improved,  for  example,  by  considering  the 
requirement  to  make  the  user  testing  process  more  iterative  and  to  ensure  that  a 
sufficiently mature version of the PL is user-tested. This iterative user-testing would 
be  coordinated  by  regulatory  authorities  in  parallel  to  the  assessment  in  a  way  that 
does  not  disrupt  the  whole  marketing  authorisation  process.  The  iterative  testing 
should focus on the content of the PL, rather  than the format and layout,  to  ensure 
that information is clear and written in a way which is easily understood by patients. 
Potential  amendments  of  the  Readability  Guideline  could  be  considered  in  this 
respect  taking  also  into  account  the  use  of  structured  benefit-risk  approaches  and 
visual representations to communicate benefits and risks to different stakeholders in 
different  situations,  including  those  approaches  developed  by  the  European 

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Medicines Agency in the context of the Benefit-Risk Methodology project16 and by 
the  Innovative  Medicines  Initiative  (IMI)  Pharmacoepidemiological  Research  on 
Outcomes of Therapeutics by a European ConsorTium (PROTECT) project.17 

4.4. 

Promotion and exchanges of best practice 

The  assessment  concluded  that  good,  user-tested  examples  of  the  PL  and  to  some 
extent also the SmPC as well as their development process could be promoted more 
by regulators to facilitate and improve the development of these documents. 

Recommendation:  Best  practice  examples  of  aspects  of  the  PL  (and  the  SmPC) 
design  could  be  made  available  for  pharmaceutical  companies  on  a  platform  that 
would  be  suitable  for  that  purpose  and  that  could  be  regularly  updated.  These 
examples  should  include  not  only  the  end  products,  but  also  information  on  the 
process of development, where possible. The selection of these examples should be 
evidence-based. 

4.5. 

Electronic SmPC/PL formats 

Electronic  formats  bring  new  opportunities  for  SmPC  and  PL.  As  more  Europeans 
gain access to information technologies, the assessment identified potential benefits 
in developing key principles as to how electronic formats can be used to provide the 
information to individual EU-citizens in accordance with the existing legislation (e.g. 
in  terms  of  presentation,  format  or  use  of  multiple  languages).  In  any  event  the 
electronic PL formats should be complementary to paper PLs that are required by the 
legislation and should not replace them at this stage in order to ensure availability of 
the information for all patients.  

Recommendation:  It  is  recommended  to  explore  the  use  of  electronic  media  to 
provide  the  information  included  in  the  SmPC  and  PL  in  the  future.  It  should  be 
further  explored  what  opportunities  new  technologies  offer  to  optimize  the 
presentation  and  design  of  SmPC  and  PL.  In  this  context  the  opportunities  for  the 
information included in the SmPC and the PL to be more easily used as an integrated 
part  of  the  care  process  should  be  explored.  For  example,  developing  mechanisms 
through electronic tools to inform patients and healthcare professionals on changes in 
the SmPC and PL should be considered. The exploratory work in this area should be 
based  on  and  further  develop  the  existing  work  done  by  the  European  Medicines 
Agency  in  this  area  and  should  follow  a  multi-stakeholder  approach  involving  also 
the  pharmaceutical  industry,  patients,  consumers,  healthcare  professionals,  the 
Member States and the Commission. The aim will be to develop the key principles 
for the use of electronic SmPC and PL formats. The results of this exploratory work 
should be submitted to the Commission for any follow-up action as appropriate. 

4.6. 

Potential key information section in the SmPC and PL 

The potential introduction of the “key information” section in the SmPC and PL with 
the  objective  to  allow  patients  and  healthcare  professionals  to  rapidly  identify  key 
safety  messages,  balanced  with  information  on  the  benefits  of  medicines,  has  been 
also  subject  to  the  assessment.  The  key  information  section  is  not  specifically 
envisaged in the existing EU legislation  on medicinal products for human use.  The 
outcome of the assessment is that more experience and evidence needs to be gathered 

16 
17 

http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123819.pdf  
http://www.imi-protect.eu  

7 

 
 
                                                            
and  that  currently  testing  can  be  considered  as  a  means  to  further  determine  the 
potential usefulness of the inclusion of a key information section in the SmPC or PL. 

Recommendation:  More  evidence  would  need  to  be  gathered  before  considering 
introduction of a key information section in the Product Information. It is suggested 
to continue further exploratory work on the use of such key information in the PL as 
well as the possibility to use Quick Response (QR) codes18 as another way to make 
available  information  to  patients.  Appropriate  testing  (e.g.  user  testing)  could  be  a 
way to demonstrate the clear evidence of the usefulness and added value to patients 
to introduce a key information section in the PL. In this respect, the work currently 
being undertaken by EMA as part of its strategy to improve information on benefit-
risk  to  patients  and  healthcare  professionals  could  be  taken  into  account.  In 
particular, the planned testing of adding a ‘key information section’ to the ‘EPAR19 
summary’  for  each  centrally  authorised  medicinal  product  could  be  used  for  this 
purpose. This may help to decide on the type of information that should be provided 
in the PL and the category or type of medicines where such a key information section 
could be useful and appropriate. 

5. 

CONCLUSIONS 

The  Commission  and  the  European  Medicines  Agency  will  work  towards 
implementation  of  the  above  mentioned  recommendations  in  order  to  improve 
certain  aspects  of  the  SmPC  and  PL  and  to  better  meet  the  needs  of  patients  and 
healthcare professionals. The work will be taken forward in close collaboration with 
the  Member  States.  It  will  be  ensured  that  the  key  stakeholders,  in  particular 
representatives  of  patient  organisations,  healthcare  professionals, 
industry 
representatives, national regulators and other relevant parties will be duly consulted 
and involved as appropriate with regards to the respective proposed possible actions.   

*** 

18 

19  

QR  code  is  a  machine-readable  optical  label  (bar  code)  that  contains  information  about  the  item  to 
which  it  is  attached.  A  QR  code  may  link  to  a  website,  web  page  (e.g.  standalone  PDF  document) 
and/or smartphone applications specifically created for that purpose. 
European Public Assessment Report. 

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