It clarifies details of GMP requirements that must be met when using non-transgenic comminuted plants and herbal extracts as active substances.
As long as the title of the document is, however, as short is the statement. Primarily, it references the applicable documents:
- The EU GMP Guideline Part II and additionally also the EU GMP Annex 7 apply.
- For herbal active ingredients, which are themselves the finished product, there will be a Q&A on finished products.
- Transgenic plants are treated separately and are covered in EU GMP Annex 2.
Source:
EMA: GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances