1. Product information (II) – aspects relevant for ACTs Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, Kampala, February 2009

2. Artemisinin combined medicines, Kampala, February 2009 2 |2 | Synopsis  A „good“ medicinal product  Product information  Patient Information Leaflet (PIL)  Structure  Format  Style  Conclusion

3. Artemisinin combined medicines, Kampala, February 2009 3 |3 | Pharmaceutical Quality Efficacy and Safety (Bioequivalence ) Product information A “Good” Medicinal Product

4. Artemisinin combined medicines, Kampala, February 2009 4 |4 | → Prequalification Programme: format according to European standards (http://www.who.int/prequal/ Guidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report (WHOPAR) )http://www.who.int/prequal/  Summary of Product Characteristics (SPC or SmPC): Main scientific information on the safe use of the product for the health care professional.  Package Leaflet /Patient Information Leaflet (PL or PIL) : Relevant information on the safe use of the product in a patient-friendly language for the user.  Labelling on outer and immediate packaging materials. Required Documents

5. Artemisinin combined medicines, Kampala, February 2009 5 |5 | Relevant European Guidelines :  on packaging information of medicinal products: http://ec.europa.eu/enterprise/pharmaceuticals/eud ralex/vol-2/c/bluebox_02_2008.pdf  on readability of the label and package leaflet http://ec.europa.eu/enterprise/pharmaceuticals/eud ralex/vol-2/c/gl981002.pdf (currently under revision) Patient information leaflet (I)

6. Artemisinin combined medicines, Kampala, February 2009 6 |6 | Patient information leaflet (II)  Legislation  Contents in accordance with the Summary of product characteristics (SPC)  One leaflet per product  Approval by competent authority  Clear and understandable  Clearly legible  Language of where the product is placed on the market  Contents of all language versions identical  Optional: local representative (for enabling patients to address queries in the local language).

7. Artemisinin combined medicines, Kampala, February 2009 7 |7 | Patient information leaflet (III)  Structure - 6 sections:  1. What {product name} is and what it is used for  2.Before you take {product name}  3.How to take {product name}  4.Possible side effects  5.How to store {product name}  6.Further information

8. Artemisinin combined medicines, Kampala, February 2009 8 |8 | Patient information leaflet (IV)  Readability  Format -Print size and type At least 8 points Didot space between lines at least 3 mm -Print colour (to highlight headings), red colour only for very important warnings -Not more than two levels of headings (numbered) -Use of capitals to be avoided -Capitals for emphasis only -Paper size: preferably A4/A5, since user-friendly -Paper weight: not less than 40g/m 2

9. Artemisinin combined medicines, Kampala, February 2009 9 |9 |  Readability (cont.)  Style -Consumer understandable language -Explanation for specific/specialized terms -Active/direct style, e.g. „Take 1 tablet once daily“ -Pictograms only in addition to clarify -Instructions prior to explanations, e.g. „take care with X when you have asthma – it may bring you on an attack.“ Patient information leaflet (V)

10. Artemisinin combined medicines, Kampala, February 2009 10 |  Readability (cont.)  Style (cont.) -Syntax Sentences not longer than 20 words Avoid subordinate clauses -Bullet points Not more than one sentence per bullet point -Whenever possible, „it“ instead of product name -Prominence to the most crucial information for the safe use of the product. -Use of Braille encouraged. Patient information leaflet (VI)

11. Artemisinin combined medicines, Kampala, February 2009 11 | Patient information leaflet (VII) Use of pictograms - difficulties

12. Artemisinin combined medicines, Kampala, February 2009 12 | Patient information leaflet (VIII)  In conclusion:  concise/comprehensible information  In a well defined/reproducible structure with  clear format and  cross-referencing between sections allows fast access to the relevant information → allows fast access to the relevant information → safe/effective use of the medicinal product