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Readability specific legislation
| Decision no. 35/13.12.2010 on amendment of Scientific Council Decision No. 16/07.06.2010 concerning change of the implementation date of the Guideline on conduct of consultation with target patient groups in view of the Summary of Product Characteristics, as approved through SCD no. 6/23.03.2010 – published on 14.12.2010 download document …  |
| Decision no. 16/07.06.2010 on change of the implementation date of the Guideline on conduct of consultation with target patient groups in view of the Summary of Product Characteristics, as amended through SCD no. 35/13.12.2010 download document … |
| Decision no. 6/23.03.2010 on approval of the Guideline on consultations with target patient groups for the package leaflet, as amended through SCD no. 16/07.06.2010 download document … |
| Decision no. 8/26.06.2009 on the approval of the Guideline on the readability of the labelling and package leaflet of medicinal products for human use download document … |
| Decision no. 22/07.11.2008 on approval of the Guideline on consultations with target patient groups – meeting the requirements of Article 59(3) of Directive 2001/83/EC without the need for a full test – recommendations for bridging download document … |
| Decision no. 21/07.11.2008 on approval of the Guideline on consultations with target patient groups for the package leaflet download document … |