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.
What are Homeopathic Medicines?
A medicinal product prepared from ___________ in accordance with a _____________ described in the European Pharmacopoeia (EP) or, in the absence of such a description in the EP, in any pharmacopoeia used officially in an EEA country
A medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia (EP) or, in the absence of such a description in the EP, in any pharmacopoeia used officially in an EEA country
List three ways in which homeopathic products may be registered in the UK currently
PSN
Product Licence of Right
Simplified Scheme.
National Rules Scheme
Facts about Product License Right(PLR)
Issued to all medicines which were on the market when the Medicines Act was introduced (___________).
PLRs may have indications (for_____________).
Companies are encouraged to re-register any existing PLRs under the ___________ Scheme or _________________.
Issued to all medicines which were on the market when the Medicines Act was introduced (1968).
PLRs may have indications (for minor symptoms and conditions that can be treated without supervision of a doctor).
Companies are encouraged to re-register any existing PLRs under the Simplified Scheme or National Rules Scheme.
Facts about Simplified Scheme
Safety and quality of products has to be demonstrated. [Products must be for oral or external use (not injections), be sufficiently dilute to guarantee their safety, and must not make any therapeutic claims.]
Products are not allowed to make medicinal claims.
Facts about National Rule Scheme
Introduced in 2006
Enables ____________ to be registered with indications for the relief of minor symptoms and conditions.
Applications must be supported by a )________________
Appropriate product labeling and product literature.
Introduced in 2006
Enables homeopathic medicinal products to be registered with indications for the relief of minor symptoms and conditions.
Applications must be supported by a dossier of data on quality, safety, and efficacy.
Appropriate product labeling and product literature.
Both herbal and homeopathic medicines are subject to regulation. TRUE/FALSE
TRUE
Licensing and regulations of both herbal and Homeopathic are the responsibility of the …..
MHRA
Pharmacists must be confident about the quality and efficacy of any products they supply. TRUE/FALSE
TRUE
