IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18

 

Inside this issue

     

EU guideline on quality aspects for vaccines

The European Medicines Agency has published a draft guideline on quality aspects included in the product information for vaccines and is asking for comments before 31 July.

The aim of the document is to “provide applicants and regulators with harmonised guidance on the quality aspects to be considered in the Summary of Product Characteristics (SmPC), Package Leaflet (PL) and labelling for vaccines for human use.”

The guidance covers the qualitative and quantitative composition of vaccines and includes a section (6.1) on the listing requirements for excipients, including excipients with known effect, as well as information on outer packaging labelling.

 

 

 

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