The Traditional Herbal Medicinal Products Directive of 2004 features a 7-year transitional period which will expire on 30 April 2011. But what will this mean for manufacturers of traditional herbal medicinal products?
A traditional herbal medicinal product is any medicinal product containing as an active ingredient herbal substances or herbal preparations which can be shown to have a traditional use of at least 30 years, with at least 15 years in the European Union.
Examples of herbals used in traditional herbal medicinal products include Calendula officinalis L; Echinacea purpurea L.; Eleutherococcus senticosus; Hamamelis virginiana L; Mentha x piperita L.
The Traditional Herbal Medicinal Products Directive (2004/24/EC) was adopted on 31 March 2004. It aims to facilitate the placing on the EU market of traditional herbal medicinal products that despite their long tradition were not eligible for a full marketing authorisation. It also seeks to ensure the protection of public health by defining guarantees of quality and safety. Although such products are natural, some can nevertheless provoke adverse reactions so they need to be covered under EU pharmaceutical legislation.
In view of the long tradition behind these medicinal products, it was decided to provide a special, simplified registration procedure. The simplified procedure allows the registration of traditional herbal medicinal products without submitting documentation on tests and trials on safety and efficacy, which the applicant would be obliged to provide under the full marketing authorisation procedure. Instead, the applicant only has to provide sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the European Union. This procedure is clearly less burdensome than the full marketing authorisation. It facilitates the access of these products to the EU market, while ensuring the safety of herbal medicines for EU citizens.
Traditional herbal medicinal products that were legally on the market before 30 April 2004 were allowed to remain on the market without complying with the Directive until the end of the transitional period. This has provided manufacturers with a full seven years to submit an application for registration. It is now up to potential applicants to submit their application to the competent Member State authorities in good time to ensure registration before the transitional period expires.
A traditional herbal medicinal product is any medicinal product containing as an active ingredient herbal substances or herbal preparations which can be shown to have a traditional use of at least 30 years, with at least 15 years in the European Union.
Examples of herbals used in traditional herbal medicinal products include Calendula officinalis L; Echinacea purpurea L.; Eleutherococcus senticosus; Hamamelis virginiana L; Mentha x piperita L.
The Traditional Herbal Medicinal Products Directive (2004/24/EC) was adopted on 31 March 2004. It aims to facilitate the placing on the EU market of traditional herbal medicinal products that despite their long tradition were not eligible for a full marketing authorisation. It also seeks to ensure the protection of public health by defining guarantees of quality and safety. Although such products are natural, some can nevertheless provoke adverse reactions so they need to be covered under EU pharmaceutical legislation.
In view of the long tradition behind these medicinal products, it was decided to provide a special, simplified registration procedure. The simplified procedure allows the registration of traditional herbal medicinal products without submitting documentation on tests and trials on safety and efficacy, which the applicant would be obliged to provide under the full marketing authorisation procedure. Instead, the applicant only has to provide sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the European Union. This procedure is clearly less burdensome than the full marketing authorisation. It facilitates the access of these products to the EU market, while ensuring the safety of herbal medicines for EU citizens.
Traditional herbal medicinal products that were legally on the market before 30 April 2004 were allowed to remain on the market without complying with the Directive until the end of the transitional period. This has provided manufacturers with a full seven years to submit an application for registration. It is now up to potential applicants to submit their application to the competent Member State authorities in good time to ensure registration before the transitional period expires.
Further information is available at: http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm
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