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Herbal Medicinal Products
According to EU Directive 2004/24/EC, traditional herbal medicinal products are defined as:
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products which have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment; |
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products that are exclusively for administration in accordance with a specified strength and posology; |
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products that are an oral, external and/or inhalation preparation; |
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products that have bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community; |
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products where the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience. |
Herbal medicines are therefore required to meet safety, quality and efficacy criteria in a similar manner to any other licensed medicines as laid out in the Traditional Herbal Medicinal Products Directive (2004/24/EC), which amends the Community code relating to medicinal products for human use (Directive 2001/83/EC).
The Herbal Medicinal Products' directive was published in April 2004 with implementation into law by 30 October 2005 . The Directive was implemented in the UK on 30 October 2005 by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and transposed into Irish law on the 23 rd July 2007 by the The Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007).However, the directive allows existing products legally on the market on/or before the regulations came into force to receive a transitional period up to 30 th April 2011, which allows companies time to prepare the necessary documentation in order to submit an application for a certificate of traditional-use registration .
The Traditional Herbal Medicinal Products Registration Scheme requires traditional herbal medicines to meet specific and appropriate standards of safety and quality. It does not require full clinical trials to prove safety but data on ‘traditional use’ i.e. manufacturers will have to prove that their products have been in medical use for at least 30 years, including 15 years in the EU.
- As laid out in the directive the following information will be required:
- Administrative data including application form (Module 1)
- Labelling/mock-up label and patient information leaflet (PIL) (Module 1)
- Summary of Product Characteristics (SmPC) (Module 1)
- Summaries of the dossier and/or required expert reports (Module 2) .
- A technical/quality dossier covering the quality of herbal ingredients and the finished herbal product. This quality dossier will need to include details of all the necessary physico-chemical, biological and microbiological tests. (Module 3)
- The application will also need to be accompanied by a bibliographic review of safety data together with an expert report. (Module 4)
- The application will need to be accompanied by bibliographic or expert evidence that the product has been in medicinal use throughout a period of 30 years-traditional use data (Module 5).
- Ivowen Limited are in a unique position to be able to advise companies on the documentation needed and the legislation to be followed.
- We can prepare and/or review your application either to the Irish Competent Authority or any other Member State Competent Authority.
- We can advise you on the steps that your company needs to take from a manufacturing point of view to comply with any EU Directives, Regulations and Notes for Guidance.
- We can write or review your Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
For more information please contact us.
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