MHRA Re-Publish Guidance On How they Regulate Traditional Herbal Medicines (THMRS)

Full Guidance Here

Manufactured herbal medicines1 placed on the UK market are required to have either a Traditional Herbal registration (THR) or a Marketing Authorisation (MA). This applies whether the product is marketed to consumers, herbal practitioners, retailers, or wholesalers. There is one principal exception in relation to herbal medicinal products. Where a manufactured herbal remedy meets both the following requirements:
• it is legally on the UK market as an unlicensed herbal remedy in accordance with s12(2) of the Medicines Act 1968 and
• was also legally on the UK market under s12(2) at 30 April 2004
It can continue to be marketed as an unlicensed herbal remedy until 30 April 2011 provided it continues to comply with the requirements of s12(2).
This leaflet and flowchart has been produced in an effort to provide guidance which will help those working within the herbal medicine sector to understand and comply with the Traditional Herbal Medicines Registration Scheme (THMRS). The guide covers the key requirements of the THMRS. It does not cover in detail all the areas you will need to consider to meet the requirements of the registration scheme.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

MHRA puts new Traditional Herbal Medicines Registration Scheme Page Live

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It covers specific and detailed information about the regulation of herbal medicines including the scope of the Legislation, restrictions that apply, who is responsible for applying for registration or other relevant licenses and what these processes involve.

Information on the background to the Directive 2004/24/EC and its European negotiations is available at our Background and policy section.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Free Regulatory Watch Service

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”