Date: 17 November 2021
Time: 11.00 - 12:00 GMT / 12.00 -13.00 CEST
Where: Online
Presenter: Alenka Drazumeric, Director of Regulatory Affairs at Billev Pharma East / Billev farmacija vzhod d.o.o.
Agenda
How are Herbal Medicinal Products regulated in Europe? The Regulatory Affairs manager is looking into the regulation on this field. Where to begin and where to look for information?
Introduction into herbals
Definitions laid down in Directive 2001/83 as amended
Historical development of regulatory landscape
Types of procedures applicable for herbals
Basics of documentation and guidelines
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