Licensing of herbal and Homeopathic medicine Flashcards
Facts about licensing of herbal medicines
It started in 2004 by March 2004 European Commission Directive on Traditional Herbal Medicines. This fully came into force in 2011.
Enacted through Medicines Act and now through Human Medicines Regulations 2012.
Requires herbal medicinal products to be licensed
Define Herbal Medicinal Product
A medicinal product whose only active ingredients are herbal substances or herbal preparations.
What is a herbal substance?
Plant or part of a plant, alga, fungus or lichen or an unprocessed exudate which is unprocessed.
HOW IS A HERBAL PREPARATION OBTAINED
A preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression etc
If a herbal product is not registered as a herbal medicinal product it can be sold in the UK as a ______________. No ___________ can be made.
If a herbal product is not registered as a herbal medicinal product it can be sold in the UK as a food or cosmetic. No medical claims can be made.
If it is a medicinal product it can be either:
A) Registered as traditional herbal medicine (THR = Traditional Herbal Registration).
Or
B) Licensed with a marketing authorisation in the normal way.
Only Products with a marketing authorisation can make claims about efficacy. TRUE/FALSE
TRUE
Why Herbal Medicines Advisory Committee was established…
To give advice on Safety, quality, and efficacy of herbal medicinal products.
Condition to be met in order for Registration of Traditional Herbal Medicines (THR) to be granted… PART 1
A) If by virtue of its composition and indications the
product is appropriate for use without the need for a
medical practitioner to:
1) diagnose the condition to be treated by the product. 2) prescribe the product. 3) monitor the products use.
Condition to be met in order for Registration of Traditional Herbal Medicines (THR) to be granted… PART 2
B) If the product is intended to be administered
at a particular strength and in accordance
with a particular posology.
C) If the product is intended to be administered
externally, orally or by inhalation
Condition to be met in order for Registration of Traditional Herbal Medicines (THR) to be granted… PART 3 YEARS
D) If the product:
1) Has been in medicinal use for a continuous
period of at least 30 years.
2) Has been in medicinal use in the EU for a
continuous period of at least 15 years.
Condition to be met in order for Registration of Traditional Herbal Medicines (THR) to be granted… PART 4
E) If there is sufficient information that the product
has:
1) It has been established that the traditional use of
the product is not harmful.
and
2) The pharmacological effects or efficacy of the
product are plausible on the basis of long-
standing use.
Condition to be met in order for Registration of Traditional Herbal Medicines (THR) to be granted… PART 5
ONE 2 ONE
Subject to exceptions, no traditional herbal medicinal product may be placed on the market or distributed by way of wholesale dealing unless a traditional herbal registration has been granted.
The principal exception is to allow herbal practitioners to prepare a product or a specific herbal product for a patient.
State the additional labelling requirement for THR
1) A statement to the effect that the product is a
traditional herbal medicine by reason of long-
standing use.
2) A statement that the user should consult a doctor
or other healthcare practitioner if symptoms persist
or if adverse effects not mentioned in the
packaging occur.
AND finally, the symbol THR needs to appear on the packaging
Unlicensed Herbal medicine exemption by MHRA….
Exemption under Regulation 3 of the HMRA (Medicines and Healthcare products Regulatory Agency).
‘herbalist exemption’
Unlicensed remedies can be made up and supplied by a practitioner to meet the needs of an individual following a one-to-one consultation.
