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What is
ESCOP?
ESCOP was
founded in June 1989 as an umbrella organisation representing national
phytotherapy associations across Europe, especially in their discussions
with European medicines regulators. Since 1996 it has been a company
limited by guarantee in the United Kingdom.
ESCOP has
the following Aims and Objectives.
Aims
To advance the scientific status of phytomedicines and to assist with
the harmonisation of their regulatory status at the European level.
Objectives
•
to develop a coordinated scientific framework to assess
phytomedicines;
•
to promote the acceptance of phytomedicines, especially within
general medical practice;
•
to support and initiate clinical and experimental research in
phytotherapy;
•
to improve and extend the international accumulation of scientific
and practical knowledge in the field of phytotherapy;
•
to support all appropriate measures that will secure optimum
protection for those who use phytomedicines;
•
to produce reference monographs on the therapeutic use of plant
drugs;
•
to further cooperation among national Associations of phytotherapy
to advance these Aims and Objectives.
Achievements
• The
publication in 1997 and 1999 of 60 Monographs on the Medicinal Uses of
Plant Drugs submitted to regulatory authorities across Europe and
accepted by the Working Party on Herbal Medicinal Products of the
European Agency for the Evaluation of Medicinal Products (EMEA) as
providing the basis for proposed core-SPC’s for European decentralised
marketing authorisations.
• An
ongoing programme to complete further monographs.
• The
co-ordination of the EU BIOMED research programme Determining European
standards for the safe and effective use of phytomedicines. Outcomes
included, amongst others, the production of the ESCOP monographs, the
establishment of an on-line reporting system for adverse reactions to
herbal remedies (PhytoNET), and the appointment of a Toxicology Panel.
• The
publication of a professional newsletter, The European Phytojournal,
available for free downloading on the Web at the ESCOP home page.
• The
organisation of five International Symposia in Brussels, Milan, the
Hague, and Cologne, with the latest in London in October 1998 under the
title Phytomedicine and Consumer Protection.
ESCOP
Definition of Phytomedicines
Phytomedicines,
or herbal medicinal products, are medicinal products containing as active
ingredients only plants, parts of plants or plant materials, or
combinations thereof, whether in the crude or processed state.
Notes
on the Definition
•
Medicinal products are defined in European Directive 65/65/EEC.
• The
production of phytomedicines is formally determined in "Quality of
Herbal Remedies" in "The rules governing medicinal products in
the European Community, Volume III, Guidelines on the quality, safety
and efficacy of medicinal products for human use" (ISBN
92-825-9619).
• Plant
materials include juices, gums, fixed oils, essential oils, and any
other directly derived crude plant product. They do not include
chemically defined isolated constituents, either alone or in combination
with plant materials.
•
Phytomedicines may contain excipients of plant or non-plant derivation.
ESCOP Constitution and
Structure
The General
Meeting of ESCOP
Members of
ESCOP meet formally at Annual General Meetings (AGM’s) or Extraordinary
General Meetings (EGM’s) as the ultimate decision-making forum of ESCOP.
Among other roles the General Meeting has the following duties:
•
to appoint Directors to the Board
•
to consider and approve annual accounts of ESCOP Ltd
•
to appoint auditors
•
to amend and repeal company rules and procedures
The Board
Honorary
Directors appointed at General Meetings, including a Chairman and
Treasurer, plus an Honorary Secretary appointed by the Directors.
Roles:
•
to execute all necessary activities between AGM’s
•
to coordinate the functions and activities of the Committees
•
to represent ESCOP in external contacts
•
to inform members at the AGM and of the Committees about developments
within ESCOP and about its own activities in particular.
The
Scientific Committees
Comprises
delegates from each member country of ESCOP as well as others as
appropriate.
Roles:
•
to produce harmonised European Monographs on the Medicinal Uses of
Plant Drugs on the basis of published information and taking account
of the traditional use within European member states
•
to set up as a referee panel a Board of Supervising Editors to
finalise drafts of the monographs
•
to submit the monographs to European regulators as proposals for core-SPC
(Summary of Product Characteristics) documents in accordance with
requirements laid down in EC Guideline 11/9163/89.
The
Research Committee
Comprises at least one
Board member and other invited individuals.
Roles:
•
to provide a network of researchers in the area of phytotherapy,
collectively referred to as the European Phytotherapy Research Group (EPRG)
•
to establish a Toxicological Panel of experts from the EPRG so as to
provide an expert review panel in the assessment of the safety of
phytomedicines
•
to produce guidelines for the determination of standards of quality,
safety and efficacy of phytomedicines
•
to involve members of the EPRG in initiatives to further standards of
quality, safety and efficacy of phytomedicines.
The
Secretariat
Honorary Secretary
appointed by the Board and supported by an employed Administrator and
other staff as necessary.
Roles:
•
to execute day-to-day correspondence and administrative work on behalf
of ESCOP
•
to support, and provide minutes for, the meetings of the Board and the
AGM
•
to act as a repository of master files for the ESCOP monographs
•
to manage sales and supply of the ESCOP monographs
•
to produce and disseminate the European Phytojournal
•
to organise Symposia and other ESCOP events
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