This guideline concerns the application of Module 3 of Annex I to Directive 2001/83/EC for human herbal medicinal products (HMPs) and Part 2 of the dossier as established by Commission Delegated Regulation (EU) 2021/805 amending Annex II of Regulation (EU) 2019/6 for veterinary medicinal products.


This guideline intends to cover the general quality aspects of HMPs (for human and veterinary use), including THMPs for human use. Products containing chemically defined isolated constituents (irrespective of whether they are of natural or synthetic origin) or a mixture thereof are not HMPs.


For HMPs, GMP recommendations should be respected. For human products – under Article 16(g) of Directive 2001/83/EC, Articles 40 to 52 apply by analogy to THMPs. This includes Article 46(f) of Directive 2001/83/EC which states that the Holder of a manufacturing authorisation shall at least be obliged to comply with the principles and guidelines of GMP for medicinal products and to use only active substances, which have been manufactured with the detailed guidelines on GMP for active
substances. For veterinary medicinal products, in accordance with Article 93(1)(j) of Regulation (EU) 2019/6 manufacturing authorisation holders shall comply with GMP for veterinary medicinal products and only use active substances that comply with GMP for active substances. Guidance is published in the “Manufacture of Herbal Medicinal Products” (The Rules Governing Medicinal Products in the European Union; Volume 4: EU Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use; Annex 7).

Consistent quality for products of herbal origin can only be assured if the starting materials are defined in a rigorous and detailed manner, particularly the specific botanical identification of the plant material used. It is also important to know the geographical source and the conditions under which the herbal substance is obtained to ensure material of consistent quality. The “guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin” (EMEA/HMPC/246816/2005) should also be applied.