Templates for Product Information and Package Leaflets
updated: 22.02.2007created: 22.02.2007
Announcement of the recommendations for the presentation of the Package Leaflet under Section 11 German Medicines Act (Arzneimittelgesetz, AMG) for human medicinal products (in accordance with Section 77 sub-section 1 AMG) and for the requirements according to Section 22 sub-section 7 sentence 2 (AMG) (Readability Testing of the Package Leaflet)as amended on 30 November 2006 Announcement (Größe: 24.63 KB)
(available in German only)
Model texts for SPC and Package Leaflet up-dated
The 14th Amendment of the German Medicines Act (Arzneimittelgesetz, AMG) Sections 11 and 11a on the structure and contents of the Package Leaflet and SPC have been revised in order to comprehend an adaptation to the European regulations. In order to ease the implementation of these new guidelines the BfArM provides templates for the Package Leaflet for medicinal products subject to prescription and not subject to prescription as well as for the SPC. In order to achieve uniformity and a smooth implementation it is suggestive to use those templates consequently. As an alternative, the templates of the QRD group at EMEA could be used.
National Implementation of theExcipients Guideline
Associated with addenda of the Ordinance on ADR Warnings, risk management provisions and court orders, the Excipients Guideline (Excipients in the Label and Package Leaflet of Medicinal Products for Human Use, pharmacos.eudra) comprises a compilation of text modules for the product informations regarding the national implementation of the European recommendation.
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