EU Traditional Herbal Registration (THR)

Background of EU Traditional Herbal Registration (THR)

Traditional herbal medicines have been used for centuries to treat a variety of ailments, and their popularity has increased in recent years as consumers seek natural remedies. The EU has developed a complex regulatory framework for traditional herbal medicines designed to ensure their safety and effectiveness for consumers. Traditional herbal registration (THR) is a type of registration that allows manufacturers to sell herbal medicines in the UK. This registration is issued by the Medicines and Health Products Regulatory Agency (MHRA) and requires manufacturers to provide evidence of product safety and pharmacological properties.

The THR mark indicates to consumers that traditional herbal medicine has undergone a rigorous application process and that they can be assured of the quality and safety of the product. While the requirements for a THR in the UK are well-defined, other countries in the EU have their own regulatory frameworks for herbal medicines.

About Us

Our experts provide guidance on the relevant regulations in each country where a company wishes to market its products and provide assistance throughout the entire THR process.

The regulatory framework for herbal medicines in the EU is complex, and companies seeking to market these products must comply with strict requirements. Our company's expertise in the regulatory requirements for herbal medicines in the EU and our experience in successfully obtaining EU THRs for our clients makes us a valuable partner for companies seeking regulatory guidance and support for their traditional herbal products. We offer a range of services to assist companies in obtaining EU THRs, including regulatory strategy development, dossier preparation, and post-approval support. Our team of regulatory experts is dedicated to providing high-quality regulatory services to our clients and can work with them at any stage of the registration process.

Our Registration Process

Our registration process typically involves the following steps:

• Assessment of the traditional use of herbal medicine
• Required document preparation
• Technical file covering herbal ingredients quality in the eCTD format for traditional herbal products
• Review of safety through expert reports including clinical and non-clinical safety areas
• A draft summary of product properties
• A mock-up label and patient information leaflets (PILs)
• THR submission through MHRA submissions
• THR review and approval

Our EU THR Application Services

Advising on regulatory procedures and dossier compilation form the core of our business. Our highly skilled management support team can reduce costs and complete projects on time and within budget while providing high-quality service to our clients. Our services include, but are not limited to:

• Provide preliminary technical and regulatory support to ensure that the client correctly prepares the materials required for the registration information.
• Guide clients to prepare the necessary materials for each module
• Review the documents provided by the client and make corrections to ensure that the quality of the documents meets the requirements.
• Provide advice and practical assistance on how to prepare dossiers in the required eCTD format
• Document translation
• Design regulatory submission strategies that combine commercial and regulatory needs
• Provide technical support for on-site inspections

Our Advantages

• We have a deep understanding of safety and efficacy data requirements, quality standards, and labeling requirements.
• We have a proven track record of navigating the complex regulatory landscape for herbal medicines.
• We have a more responsive customer support team and offer more personalized assistance.

If you need help or have a question, please feel free to contact us for more details.