Declaration of Herbal Substances & Herbal Preparations in HMPs

Recommendation

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The HMPC issued a concept paper on the revision of the guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs). The document has been published for comment until 31 May 2023.

Background

The guideline was initially published in 2007 and first revised in 2010. It outlines the principles for uniform declaration of herbal substances in HMPs. The declaration is primarily intended to describe the identity and quantity of the herbal drug / herbal drug preparation (e.g. extracts), being the active substance of the HMP.  Examples of declaration of such active substances are provided (e.g., for standardized, quantified & other extracts). The main guideline describes the declaration in the Summary of Product Characteristics (SmPC), including definitions e.g. for analytical markers, strength, drug extract ratio (DER), excipients, while package leaflets, labelling and other herbal-specific provisions are provided in Annex 1 to the guideline.

Examples of abbreviated declaration in HMP labelling

The following examples of abbreviated declaration in HMP labelling are provided in Annex 1 of the current guideline, provided that this will not affect the safe use of the product:

• Wherever possible the labelling should include the plant name(s) stated in the SmPC.
• The extraction solvent may be omitted, if justified.
• The physical state of a herbal preparation may be omitted, e.g. “extract (as dry extract)” may be abbreviated to “extract”.
• If justified for a herbal drug preparation, the equivalent quantity of the herbal drug may be replaced by the ratio of the herbal substance to the genuine herbal drug preparation and vice versa.

Concept Paper

A concept paper has now been published describing the need to revise this guideline, since not all of its contents correspond to the current status. Among other things, updates and revisions of the specifications of the European Pharmacopoeia (Ph. Eur.), the HMPC guidelines on the quality of herbal medicinal products as well as experiences from approval and registration processes are to be considered. Interested parties (i.e., regulators, pharmaceutical industry, academic groups, and Ph. Eur. expert groups) are initially invited to provide suggestions and examples on this concept paper. In a second step, specific comments on the draft revised guideline can be provided during public consultation and will be addressed in an overview of comments that will be published together with the final revised guideline.

More detailed information is available in the Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ published on the EMA HMPC website.