Herbal & Homeopathic Remedies Flashcards
What is the HMR 2012 definition of ‘Herbal Medicinal Product’?
a medicinal product whose only active ingredients are
- herbal substances
- herbal preparations
- or BOTH of the above
What is a ‘Herbal Substance’?
a plant or part of a plant, defined by the plant part used and the botanical name of the plant, either FRESH or DRIED but other wise
- UNPROCESSED
this is NOT a registered product
What is a ‘Herbal Preparation’?
a preparation obtained by different processes, so that the product is considered
- PROCESSED
this is NOT a registered product
What is a ‘Traditional Herbal Medicinal Product’?
this is a herbal medicinal product to which regulation 125 applies, and to which the traditional herbal registration can be granted under by the MHRA - this follows an EU directive
- this is where the traditional long standing use of the product grants it an authorisation and can be registered
- manufactured and industrially produced product
What are the 4 types of Herbal Remedies?
- Licensed Herbal Medicines - holds a MARKETING AUTHORISATION like normal licensed medicines and are regulated as normal medicines
- Registered Traditional Herbal Medicines - that hold a Traditional Herbal Registration (125)
- Unlicensed Herbal Products - where it is supplied to an individual patient following a face-to-face consultations with a herbalist practitioner (like off-license medicines)
- NOT MEDICINES - where they don’t require a Marketing Authorisation OR a Traditional Herbal Registration. These may be food supplements or cosmetics that are registered elsewhere. Anything that has a therapeutic effect WILL have an MA/THR
Who are the people that the MHRA recognises as SUPPLIERS of herbal remedies?
- Pharmacists
- Dealers of Traditional Herbal Medicines that SELL remedies requested by customers (e.g. like in health food shops)
- Actual herbalist PRACTITIONERS - that can make up the unlicensed herbal remedies
What do Herbal Practitioners do?
- use specialist knowledge to prescribe medicinal products to people seeking treatment and they accept all legal liability
- can practice from consulting rooms OR operate from a shop that’s lockable - where they would also act as the dealer
- they can deal in ANY herb and give/sell licensed and unlicensed products as long as:
ITS A ONE TO ONE CONSULTATION
THE PATIENT IS PRESENT IN PERSON
Exemptions to regulations that allow herbal practitioners to operate?
- no manufacturer’s license needed - because they manufacture and assemble unlicensed products AS LONG AS THEY ARE ON A PREMISE THAT CAN EXCLUDE THE PUBLIC
- a herbalist is able to administer to ADMINISTER the herbal product after its been requested by or on behalf of that person and in that’s person’s presence
NOTE: HERBAL PRACTITIONERS ARE NOT REQUIRED TO REGISTER WITH AN ORGANISATION
Can the MHRA ban the sale/supply of herbal remedies if there are suspected adverse effects that result from their use?
YES. There is also legislation in place that prohibits certain herbs as some herbs can be dangerous.
What is the legal basis for the restrictions on Herbal Medicinal Products supplied by ‘herbalists’?
HMR 2012 Schedule 20
What does Part 1 of the HMR 2012 Schedule 20 restrictions state regarding herbal medicinal products? (UNLICENSED PRODUCT)
PART 1 MAY ONLY BE SOLD BY PHARMACISTS FROM REGISTERED PREMISES
- no sale or supply of herbal medicines if they contain one or more of the listed herbs in part 1 EXCEPT
if it’s from a pharmacy under supervision of a pharmacist
they consider pharmacist’s to be more knowledgeable about these products than herbalists
Part 1: a list of herbs herbalists CAN’T sell
What does Part 2 of the HMR 2012 Schedule 20 restrictions state regarding herbal medicinal products? (UNLICENSED PRODUCT)
plants listed in part 2 can only be sold by a herbalist if
- they are sold following a one-one consultation
- they are NOT over the maximum dose stated in part 2
If they are OVER the maximum concentration - they can only be sold in a pharmacy under supervision of a pharmacist
Part 2: a list of herbs herbalists CAN sell, but only if they’re under the doses stated
What are the conditions to be met in order for a product to be considered a ‘Traditional Herbal Medicinal Product’ under regulation 125?
- don’t need a medical practitioner to diagnose/prescribe/monitor the product’s use
- product is intended to be administered at a particular strength/dose
- product intended to be administered externally/orally/inhalation ONLY
- PRODUCT HAS BEEN IN MEDICINAL USE FOR A CONTINUOUS PERIOD OF 30 YEARS AND FOR A CONTINUOUS PERIOD OF 15 YEARS IN THE EU
- sufficient information about the traditional use, so that we know the use isn’t harmful and that the efficacy of the product is PLAUSIBLE (based on long-standing use, is not CLINICALLY proven)
What are the additional labelling requirements for a Traditional Herbal Medicinal Product?
- a statement that the product is a traditional herbal medicinal product - for the use of specific purposes by reason of long-standing use
- statement that the user should consult
1. A doctor/other HCP if symptoms of what the patient is trying to treat persists
2. A doctor/other HCP if adverse effects that are NOT mentioned on the package/leaflet occur
What is the European Positive List?
a list of herbal substances that traditional use doesn’t need to be demonstrated by individual manufacturers
- for cases where there has not been traditional use of 30 years
In order to manufacture Traditional Herbal Medicinal Products, you need to have a manufacturer’s licence - true or false?
TRUE
In order to partake in wholesale dealing of Traditional Herbal Medical Products, you don’t need to have a wholesale dealers license - true or false?
FALSE
When importing a traditional herbal medicinal product from a NON EU COUNTRY, you need a wholesale dealer’s license - true or false?
TRUE
The advertising of Traditional Herbal Medicinal Products lies with who?
PAGB Medicines Advertising Code for Traditional Herbal Medicines
What advertising requirements are there regarding Traditional Herbal Medicinal Products?
have to have the following statement
‘traditional herbal medicinal product for use in.. is exclusively based upon long-standing use as a traditional remedy’
it has to be clearly stated that efficacy HASN’T been tested, only based on 30+ years of use so that it becomes plausible
What is homeopathy?
- like cures like
if a substance actually CAUSES the symptoms of the disease - can use it and dilute it down in order to TREAT the symptoms
- the more diluted the substance, the more potent it is
What is a Product Licence of Right?
applies to HOMEOPATHIC medicinal products
- for products that were on the market BEFORE the Medicines Act in 1968
- for minor conditions that patients can treat themselves
What is the Simplified Registration Scheme?
applies to HOMEOPATHIC medicinal products
- for products that were made AFTER the Medicines Act in 1968
- regulated under HMR 2012
- NO therapeutic indication allowed, but still tested for their safety and efficacy
What is the National Rules Scheme 2006?
applies to HOMEOPATHIC medicinal products
- relief/treatment of MINOR symptoms and conditions
this is similar as to when applying for a marketing authorisation with normal medicinal products - except you would get an NR instead of an MA
