Statements

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Statement relating to the draft: "Questions and answers on sodium in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev.1)"

Discussion to date: May 2015

Questions and answers on sodium in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev.1) - Draft (PDF)

Statement relating to the draft: "Questions and answers on sodium laurilsulfate in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev.1)"

Discussion to date: September 2015

Questions and answers on sodium laurilsulfate in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev.1) - Draft (PDF)

Statement relating to the QRD template draft

Discussion to date: April 2012

QRD template - draft April 2012 (PDF)

Statement relating to the QRD template draft

Discussion to date: July 2012

QRD template - draft July 2012 (PDF)

1st statement relating to the QRD template draft

Discussion to date: February 2010

QRD template - draft February 2010 (PDF)

2nd statement relating to the QRD template draft

Discussion to date: October 2010

QRD template - draft February 2010 (PDF)

Proposals to optimise the German QRD template

German QRD Template: Discussion and proposals to date - June 2007

Statement relating to the draft: 2nd proclamation of the revised version regarding the recommendations for package insert design according to paragraph 11 of the German drug law for human pharmaceuticals

Discussion to date: April 2006

Statement relating to the draft "Guideline on the readability of the label and package leaflet of medicinal products for human use"

Discussion to date: September 2006

Guideline on the readability of the label and package leaflet of medicinal products for human use - Draft (PDF)

Statement relating to the IQWIG health information draft

Discussion to date: October 2006


Last update: 30.10.2018

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