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The views presented in these documents are those of the HMPWP, which has been created as a forum for exchange of experience in the field of herbal medicinal products. These documents are released for the purposes of transparency and have no legal force with respect to Directive 2001/83/EC.
Drafted Working Documents
Quality
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Working party on Herbal Medicinal Products: points to consider on the biopharmaceutical characterisation of Herbal Medicinal Products | (English only) | draft: consultation closed | 09/07/2003 |
Pharmacovigilance
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Draft postition paper on the use of herbal medicinal products containing pulegone and menthofuran | (English only) | 24/05/2004 | |||
| Working party on Herbal Medicinal Products: Draft proposal for a core-data for Nettle root | (English only) | draft: consultation closed | 09/07/2003 | ||
| Working party on Herbal Medicinal Products: Draft proposal for a Devil's claw root | (English only) | draft: consultation closed | 04/04/2000 | ||
| Working party on Herbal Medicinal Products: Draft proposal for a core data for Hop Strobile | (English only) | draft: consultation closed | 31/03/2000 | ||
| Working party on Herbal Medicinal Products: Draft proposal for a core data for Melissa leaf | (English only) | draft: consultation closed | 31/03/2000 | ||
| Working party on Herbal Medicinal Products: Draft proposal for a core data for Passion flower | (English only) | draft: consultation closed | 31/03/2000 |
Regulatory
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Draft points to consider on the evidence of safety and efficacy required for well-established Herbal Medicinal Products in bibliographic applications | (English only) | draft: consultation closed | 25/10/1999 |
Finalised Working Documents
Quality
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Compilation of general quality questions addressed by the HMPWP | (English only) | 11/06/2004 | |||
| Working party on Herbal Medicinal Products: Final proposals for comments on the Committee for Proprietary Medicinal Products (CPMP) note for guidance on stability testing after a Type II Variation to a marketing authorisation | (English only) | 01/11/1999 |
Safety
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Ad hoc working group on Herbal Medicinal Products: Proposal for a Note for guidance on non-clinical testing of herbal drug preparations with long-term marketing experience - Guidance to facilitate mutual recognition and use of bibliographic data | (English only) | 17/09/1998 |
Efficacy
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Ad hoc working group on Herbal Medicinal Products: Note for guidance on fixed combinations of Herbal Medicinal Products with long-term marketing experience - Guidance to facilitate mutual recognition and Uue of bibliographic data | (English only) | 28/01/1999 |
Pharmacovigilance
Regulatory
Other documents
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Working party on Herbal Medicinal Products: Points to consider on good agricultural and collection practice for starting materials of herbal origin | (English only) | 02/05/2002 | |||
| Ad hoc working party on Herbal Medicinal Products: Final comments for revision of good manufacturing practice (GMP) provisions | (English only) | 17/09/1998 |