Revision of the EU GACP Guide

What does this mean for the production of medical cannabis products, from cultivation to the counter of the dispensing pharmacy?

In August the revised EU "Guideline on Good Agricultural and Collection Practices for Starting Materials of Herbal Origin" (EMA/HMPC/246816/2005 Rev. 1) was published by EMA. This guidance establishes a framework for quality assurance prior GMP needs to be followed. This guideline has been in force since 2006 and is binding in Europe, as Annex 7 of the EU GMP Guide explicitly refers to them. This guideline considers the special features of herbal starting materials and covers the entire processing of plants used for the manufacture of medicinal products. In the revised version now particular requirements for indoor cultivation are contained in annex 1. Several details and clarifications in the revised guideline have consequences for the production of cannabis flowers and respective medicinal products along the value chain and the demarcation between GACP and GMP.

Within the framework of an audit, it is the responsibility of the distributor in the European Union to verify whether the requirements of GACP are fulfilled. The activities according to GACP are followed by the manufacture of the herbal preparation or the herbal medicinal product, which must be carried out under quality assurance measures according to Good Manufacturing Practice (GMP). The responsibility for performing an appropriate demarcation between GACP and GMP lies with the medicinal product manufacturer.

Our webinar will address all these issues for cannabis cultivation and further processing in medicinal cannabis products. We will also outline critical quality attributes for different types of medicinal cannabis products and impact on demarcation between GACP, GMP II and GMP I, respectively.

Part 1 – Regulatory topics (90')

• Definitions provided in the Ph. Eur. and DAB
• Definitions provided in the HMPC paper
• Types and characteristics of different medicinal cannabis products
• GACP | GMP II | GMP I – what are the regulatory requirements in the EU
• GACP: Changes in the revised guideline with consequences for cultivation of Cannabis
• Demarcation issues and established practice by EU competent authorities
• GMP: EU GMP certification of cultivation sites needed?
• Audits to be performed
• Roles and responsibilities assigned to the various economic operators

Part 2 -  Cannabis specific topics and impact on demarcation between GACP, GMP II and GMP (130')

• Impact of provisions provided in the Ph. Eur. and DAB
• Critical quality attributes of cannabis flowers used for different purposes 
  • Foreign matter
  • Water content
  • Microbial quality
  • Cannabinoids and terpenoids
• Critical process parameters
  • Drying
  • Trimming
  • Packaging
• Regulatory requirements for decontamination 

Duration: approx. 220 minutes (both parts together)
Presentation language: English
Recording from 10/2025
Speaker: Dr. Markus Veit

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• Attractive special prices or discounts for entire teams or small groups.
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Feel free to contact us by email at info(at)alphatopics.de or by phone - we look forward to your enquiry.

Note on contingent call-off: When booking this webinar described here, two unit will be deducted per participant.