GUIDELINE ON THE READABILITY OF THE …
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals
Brussels, 12.1.2009
ENTR/F/2/SF/jr (2009)D/869
GUIDELINE ON THE READABILITY OF THE LABELLING AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS
FOR HUMAN USE
Revision 1, 12 January 2009
Document History: Date of publication by the Commission Date of coming into operation: Supersedes:
Reason for Revision:
12 January 2009
12 June 2009
"Guideline on the readability of the label and package leaflet of medicinal products for human use", version of 29 September 1998
Amendment of Directive 2001/83/EC by Directive 2004/27/EC
Keywords: Label, package leaflet, medicinal products for human use, readability
TABLE OF CONTENTS
LEGAL FRAMEWORK ................................................................................................. 5
PURPOSE OF THIS GUIDELINE ................................................................................. 6
CHAPTER 1 LABELLING
READABILITY OF THE PACKAGE LEAFLET AND THE ......................................................................................................... 7
SECTION A
RECOMMENDATIONS FOR THE PACKAGE LEAFLET ............ 7
GENERAL CONSIDERATIONS ................................................................................... 7
1. TYPE SIZE AND FONT......................................................................................... 7
2. DESIGN AND LAYOUT OF THE INFORMATION.............................................. 8
3. HEADINGS ............................................................................................................ 8
4. PRINT COLOUR.................................................................................................... 8
5. SYNTAX ................................................................................................................ 9
6. STYLE.................................................................................................................... 9
7. PAPER.................................................................................................................. 10
8. USE OF SYMBOLS AND PICTOGRAMS........................................................... 10
9. ADDITIONAL INFORMATION .......................................................................... 10 9.1. Product ranges ............................................................................................. 10 9.2. Products administered by a healthcare professional or in a hospital ............... 11
10. TEMPLATES FOR THE PACKAGE LEAFLET .................................................. 11
SECTION B
RECOMMENDATIONS FOR THE LABELLING ........................ 12
GENERAL CONSIDERATIONS ................................................................................. 12
1. NAME OF THE MEDICINE ................................................................................ 12
2. STRENGTH AND TOTAL CONTENT................................................................ 13
3. ROUTE OF ADMINISTRATION......................................................................... 13
4. DESIGN AND LAYOUT...................................................................................... 13
2
5. TEMPLATES FOR LABELLING......................................................................... 14 6. OTHER INFORMATION ..................................................................................... 15 7. BLISTER PACK PRESENTATIONS ................................................................... 15 8 SMALL CONTAINERS........................................................................................ 15
CHAPTER 2 SPECIFIC RECOMMENDATIONS FOR BLIND AND PARTIALLY- SIGHTED PATIENTS .......................................................................... 16 1. LEGAL TEXT ...................................................................................................... 16 2. IMPLEMENTATION ........................................................................................... 16 3. BRAILLE.............................................................................................................. 16 4. SCOPE.................................................................................................................. 17 5. PACKAGING ....................................................................................................... 18 6. PACKAGE INFORMATION LEAFLET FOR BLIND AND PARTIALLY-
SIGHTED ............................................................................................................. 18
CHAPTER 3 GUIDANCE CONCERNING CONSULTATIONS WITH TARGET PATIENT GROUPS FOR THE PACKAGE LEAFLET................................ 19 1. INTRODUCTION................................................................................................. 19 2. SCOPE.................................................................................................................. 19 3. FORMS OF PATIENT CONSULTATION ........................................................... 19
3.1 User testing.................................................................................................. 20 3.2 Other methods.............................................................................................. 20 4. DEMONSTRATION OF PATIENT CONSULTATIONS ..................................... 20 4.1 New consultation for a medicinal product ..................................................... 20 4.2 Reference to already approved package leaflets according to Article
59(3) and Article 61(1) of Directive 2001/83/EC .......................................... 21 5. TESTING OF MULTIPLE LANGUAGE VERSIONS.......................................... 21 6. PRESENTATION OF RESULTS.......................................................................... 22 7. APPROVAL BY THE COMPETENT AUTHORITY ........................................... 23 ANNEX - ILLUSTRATION - ONE WAY OF UNDERTAKING A TEST OF A
PACKAGE LEAFLET .......................................................................................... 24 1. PERFORMING THE TEST .................................................................................. 24
3
2. RECRUITING PARTICIPANTS .......................................................................... 24 3. SUGGESTED TESTING PROCEDURE .............................................................. 25 4. PREPARING FOR THE TEST ............................................................................. 25 5. SUCCESS CRITERIA .......................................................................................... 26
4
Legal framework
All medicinal products placed on the Community market are required by Community law to be accompanied by labelling and package leaflet which provide a set of comprehensible information enabling the use of the medicinal product safely and appropriately.
According to Article 54, Article 55 and Article 59 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 use1 (hereinafter: "Directive 2001/83/EC") medicinal products must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet.
Article 58 of Directive 2001/83/EC allows for the omission of a package leaflet where all the required information can be directly conveyed on the packaging.
Article 56 of Directive 2001/83/EC requires that the particulars to be included in the labelling shall be easily legible, clearly comprehensible and indelible.
Article 56a of Directive 2001/83/EC requires the name of the medicinal product (as referred to in Article 54(a)) to be expressed in Braille format on the packaging, and the marketing authorisation holder to ensure that the package leaflet is made available on request from patients' organisations in formats appropriate for the blind and partiallysighted.
Article 59(3) of Directive 2001/83/EC provides that the package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
Articles 61(1) and 8(3)(j) of Directive 2001/83/EC specify that one or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the competent authority at the time of marketing authorisation application. The results of assessments carried out in cooperation with target patient groups shall also be provided.
Article 63(1) of Directive 2001/83/EC requires that the labelling and package leaflet shall appear in the official language or languages of the Member State where the product is placed on the market. Additional languages can be included provided the information presented is the same in all languages.
Article 63(2) of Directive 2001/83/EC requires that the package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the official language or languages of the Member State(s) in which the medicinal product is placed on the market.
1 OJ L 311, 28.11.2001, p. 67.
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- counseling skills and techniques 10 basic
- guideline on the readability of the
- tf cbt in early childhood
- drawing made easy a helpful book for young artists the
- creative interventions for online therapy with children
- motivational interviewing mi rolling with resistance
- counseling skills and techniques 5 behavioral approach to
- the 44 phonemes graphemes
- bullying awareness lessons activities and resources
- winter quarter 2020 21
Related searches
- articles on the importance of reading
- sermons on the mission of the church
- quotes on the importance of family
- word on the tip of my tongue
- blogs on the adventures of tom sawyer
- assess the impacts of the french policy of assimilation on africans
- aristotle on the purpose of the polis
- pain on the side of the foot
- teaching on the fruit of the spirit
- study on the fruit of the spirit
- pain on the inside of the knee
- the sound of the sand blowing on the beach was soothing