|  
Simplified Registration Procedure
 Traditional
herbal registration (THR)
The new scheme:
The Traditional Herbal Medicines Registration Scheme (THMRS)
was introduced to protect public health. It demands much more
information regarding safety, quality and efficacy than is
currently required for unlicensed herbal products, thus bringing
them more in line with any other licensed medicines.
Which products will need to meet the requirements
and when?
Unlicensed manufactured herbal medicines that were placed
on the market under section 12(2) of the Medicines Act before
April 30th 2004 (when the new Directive came into
force) will have until April 30th 2011 to meet the requirements
of the scheme. Herbal medicines, placed on the market after
April 30th 2004 do not qualify for the transitional
protection phase and will need to meet the requirements of
the THR scheme or apply for a Market Authorisation (MA).
Eligibility
You will only be able to register your product using the THR
scheme if it is intended and designed for use without the
supervision of a medical practitioner for diagnostic purposes
or for prescription or monitoring of treatment. In addition,
the product must be an oral, external and/ or inhalation preparation.
The
data requirements can be summarised as:
• Bibliographic or expert evidence demonstrating
'traditional use'.
• Authoritative literature on herbalism.
• Testimony of recognised experts on herbalism.
|
What are the requirements?
The normal requirement to produce data to prove efficacy is
replaced by a requirement to demonstrate 30 years
traditional use for the required medicinal indication.
Normally, at least 15 years of this usage must have been within
the EU.
Safety requirements
In addition to the above, you will also need to provide a
bibliographic review of safety data together with an expert
report. An important aspect of safety is that the products,
including their indications, must be suitable for over the
counter sale and use without medical supervision.
Quality requirements
The normal quality requirements applicable to licensed medicines
will apply. Compliance with Good Manufacturing Practice (GMP)
will be required. There will also be a requirement to hold
a manufacturer's licence, a wholesale dealer's licence or
a wholesale dealer's (import) licence where appropriate.
|
