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EU GACP Certification scheme

Posted at September 29, 2021 » By : » Categories : News & Events » Comments Off on EU GACP Certification scheme

During the last few years, an increased interest in the role of cannabis in treating medicinal conditions has led the pharmaceutical industry to expand their research, in search of scientific evidence to support the use of medicinal cannabis.  Furthermore, an overview of laws and policies around the world, including legislation on the production, distribution and consumption of cannabis-based products results in an emerging market. In December 2020 the UN following a recommendation from experts at the WHO, recognized the medicinal value of cannabis.

Although there is no common legal framework within the European Union, several countries including Greece, the Netherlands, Germany, Malta etc. have developed regulatory initiatives related to the cultivation and process of medicinal cannabis. 

The pharmaceutical industry, mainly in central Europe, is using medicinal cannabis produce as a starting material for a range of medicinal products, or as an active pharmaceutical ingredient; moreover, in some countries, the use of medicinal cannabis as an end product (dried flos) is also regulated. In both cases, the herbal substance used, shall be of suitable quality. To achieve this, a producer shall develop and implement a system that will ensure that growing and harvesting of medicinal cannabis is done using best cultivation/harvesting practices. This quality system along with the Good Agricultural Practices for the cannabis plant is essential to the consistent quality and safety of the herbal medicinal product required by Pharmaceutical companies.

The EMA Committee on Herbal Medicinal Products (HMPC) established a “Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin” back on 2006 (EMEA/HMPC/246816/2005). This Guide describes a set of rules regarding the cultivation, collection, and primary processing of the medicinal plant/herbal substance. However, the document describes those rules for a broad range of plants and not in a detailed way.

Since then, several Guidelines based on the initial EU GAPC Guide were developed by European Countries and the private sector, to thoroughly describe the Good Agricultural Practices for the cultivation of medicinal cannabis. Moreover, the European Commission has presented the rules governing Medicinal Products (EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use / Annex 7: Manufacture of Herbal Medicinal Products), describing the Good Manufacturing Practices for the manufacture of herbal medicinal practices. These rules apply (overlap) to some extent, to the post-harvesting processes in the case of medicinal cannabis.

Q-CERT LTD, a leader in the agricultural certification market, with extensive experience in many GAP schemes and protocols (GlobalG.A.P., AGRO, etc.), has developed a GACP Regulation for Herbal Origin Product Certification, that includes the “Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin”.

The QMS GACP Regulation is based on the following:

  1. Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin”, EMEA/HMPC/246816/2005.
  2. Guidelines for cultivating cannabis for medicinal purposes”, by Dutch Government, December 2002.
  3. General Guidelines on the Production of cannabis for medicinal and research purposes”, by Malta Medicines Authority, December 2018.
  4. “EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use/ Annex 7: Manufacture of Herbal Medicinal Plants”, by European Commission, September 2008.
  5. GLOBALG.A.P. IFA v5.1, by GLOBALG.A.P., July 2017.
  6. ISO 9001:2008, Quality management systems – Requirements”, by ISO, November 2008.

For more information regarding the EU GACP Certification Scheme contact us at info@qmscert.com

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