How does GMP apply for Herbal Medicinal Products?

The EMA published revised Questions & Answers on the European Union framework for (traditional) herbal medicinal products, including those from a “non-European” tradition.

The document answers questions on the following topics

  • Terminology of herbal medicinal products (HMPs), e.g., "What are herbal substances, herbal preparations, and herbal medicinal products?"
  • EU Regulation of HMPs
  • Specific provisions for traditional HMPs
  • Type and role of monographs in the EU regulatory framework
  • Advice, procedures and competent institutions

Amongst others two new interesting questions with corresponding answers regarding GMP and GACP have been introduced (No. 10 and 11):

  • What is Good Manufacturing Practice (GMP) and how does it apply for HMPs? 
    Any manufacturer of medicines intended for the EU market (whether HMPs or not) must comply with GMP. The EU GMP Guide (EudraLex Volume 4) provides interpretation of the GMP principles and guidelines, accompanied by a series of annexes that contain detailed guidelines for certain types of products. E.g., Annex 7 provides information regarding the manufacture of HMPs. In the EU, the national competent authorities ("GMP Inspectorates") are responsible for inspecting manufacturing sites located in their own territories. Manufacturing sites outside the EU are inspected by the competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections. A "GMP certificate" is issued following a GMP inspection, by the competent authority responsible for carrying out the inspection, to confirm the GMP compliance status of the inspected site.

  • What is Good Agricultural and Collection Practice (GACP) for HMPs?
    GACP represents recommendations on an appropriate quality assurance system for selection of seeds, cultivation, collection and harvesting conditions of plants (see “Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin”). Annex 7 of the EU GMP Guide includes a table illustrating the application of good practices (including GACP) to the manufacture of HMPs. However, there is currently no accredited "GACP certificate". Applicants usually have to provide/include data and details of the cultivation/collection of the herbal substance/plant material in module 3 of the CTD. A statement of conformity (written GACP confirmation) with the GACP guideline has also to be provided and is supported by information from their suppliers.

More details can be found in the Q&A document on the EMA website.

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