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Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

REFERENCES ....................................................................................................................................... 14

Key Points:

REFERENCES ....................................................................................................................................... 14
29

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 3/14

30

EXECUTIVE SUMMARY

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This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

37

1.
Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
(either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
The used cultivation method may be dependent on
the final application of the herbal medicinal product.
primary processing of herbal substances that are used for the preparation of herbal medicinal products.
medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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resistant or tolerant to disease should preferably be used.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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273

The application should be carried out only by qualified staff using approved equipment.
The following should be noted:
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 11/14

347
348

directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
The label must be clear, permanently fixed and made from
6

Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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386
387

non-toxic material.
Certain exudates that have not been subjected to a specific treatment are
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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426
427

also considered to be herbal substances.
European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points:

REFERENCES ....................................................................................................................................... 14
29

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 3/14

30

EXECUTIVE SUMMARY

31
32
33
34
35
36

This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

37

1.
Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
(either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
The used cultivation method may be dependent on
the final application of the herbal medicinal product.
primary processing of herbal substances that are used for the preparation of herbal medicinal products.
medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 5/14

104

4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 6/14

147
148
149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 7/14

185

7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 8/14

227
228

resistant or tolerant to disease should preferably be used.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 9/14

268
269
270
271
272
273

The application should be carried out only by qualified staff using approved equipment.
The following should be noted:
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 10/14

309
310

?

311
312
313

?

314
315
316
317

?

318
319
320

?

321
322

?

323
324
325

?

326
327
328

?

Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 11/14

347
348

directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
The label must be clear, permanently fixed and made from
6

Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 12/14

386
387

non-toxic material.
Certain exudates that have not been subjected to a specific treatment are
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 13/14

425
426
427

also considered to be herbal substances.
European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.

Optimi Health Receives Finished Product Test Results and Certificate Of Analysis for GMP Natural Psilocybin Extract

Retrieved on:

Tuesday, April 2, 2024

Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.

Key Points:

Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.
The third-party COA confirms critical information regarding potency, water content, microbial content, and heavy metal content, ensuring that the Natural Psilocybin Extract meets the predetermined specifications.
The completion of both extract validation and finished product testing aligns with Optimi's goal of advancing the drug candidate, marking significant progress toward its eventual release for human consumption.
“Obtaining successful results on the validation batches of psilocybin extract speaks to Optimi’s dedication to developing a repeatable, quality focused manufacturing process.

Avant and IMC Execute BLK MKT™ Trademark Licensing Agreement for the German Medical Cannabis Market

Retrieved on:

Thursday, April 4, 2024

BLK, IMCC, Partnership, FRA, Avant, TSX, SKU, GACP, Marketing, Government, Drug

The Licensing Agreement constitutes another major milestone with respect to the relationship between the two cannabis companies.

Key Points:

The Licensing Agreement constitutes another major milestone with respect to the relationship between the two cannabis companies.
Under the terms of the Trademark License Agreement, Avant's subsidiary will grant IMC Germany the license to utilize Avant's BLK MKTTM cannabis brand for use on their medical cannabis products.
Both companies believe the Licensing Agreement will enhance the companies' capabilities to meet the demands of the German market.
"We believe that our collaboration with Avant will continue to accelerate the strong momentum we have established in the German medical cannabis market," stated Richard Balla, CEO of IMC Germany.

Avant and IMC Execute BLK MKT™ Trademark Licensing Agreement for the German Medical Cannabis Market

Retrieved on:

Thursday, April 4, 2024

BLK, IMCC, Partnership, FRA, Avant, TSX, SKU, GACP, Marketing, Government, Drug

The Licensing Agreement constitutes another major milestone with respect to the relationship between the two cannabis companies.

Key Points:

The Licensing Agreement constitutes another major milestone with respect to the relationship between the two cannabis companies.
Under the terms of the Trademark License Agreement, Avant's subsidiary will grant IMC Germany the license to utilize Avant's BLK MKTTM cannabis brand for use on their medical cannabis products.
Both companies believe the Licensing Agreement will enhance the companies' capabilities to meet the demands of the German market.
"We believe that our collaboration with Avant will continue to accelerate the strong momentum we have established in the German medical cannabis market," stated Richard Balla, CEO of IMC Germany.

Greenway Products Available Online, Update on International Sales Accreditation

Retrieved on:

Wednesday, March 27, 2024

WHO, Ontario Cannabis Retail Corporation, Sale, GACP, EMA, Drug

Greenway has begun the process of getting a CUMS-GAP certificate and GACP certified, accreditation standards that are required to sell into a multitude of countries around the globe.

Key Points:

Greenway has begun the process of getting a CUMS-GAP certificate and GACP certified, accreditation standards that are required to sell into a multitude of countries around the globe.
"Our team is thrilled to see our MillRite Lavender Haze pre-rolls available for sale through the Ontario Cannabis Store.
"I am also happy to be able to give an update on our pursuit of expanding our wholesale cannabis sales to the international market," said Jamie D'Alimonte, CEO.
We have already begun the accreditation process, and have entered into conversation with a few different international cannabis purchasers as well as some of our already established domestic partners who have established international sales routes, in anticipation of completing the process."

Curaleaf to Acquire Northern Green Canada to Bolster European Flower Supply

Retrieved on:

Tuesday, March 19, 2024

Certification, Establishment, Acquisition, NGC, GMP, Cannabis, TSX, GACP, THC, Drug

NEW YORK, March 19, 2024 /PRNewswire/ -- Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer cannabis products, today announced it has signed a deal to acquire Northern Green Canada ("NGC"), a vertically integrated Canadian licensed cannabis producer focused primarily on expanding in the international market through its EU-GMP certification. NGC also partners with Canadian GACP cultivators to produce and distribute finished cannabis products to both the domestic and global markets.

Key Points:

NGC also partners with Canadian GACP cultivators to produce and distribute finished cannabis products to both the domestic and global markets.
By integrating NGC, Curaleaf can significantly increase its European margins while extending its global footprint across three continents: North America, Europe, and Australasia (Australia/New Zealand).
It allows Curaleaf to safeguard our position in Europe, enhancing our supply chain while increasing our margins.
Lisa McCormack, President and CEO of Northern Green Canada, said, "The NGC team is excited to become a part of the Curaleaf family.

Curaleaf to Acquire Northern Green Canada to Bolster European Flower Supply

Retrieved on:

Tuesday, March 19, 2024

Certification, Establishment, Acquisition, NGC, GMP, Cannabis, TSX, GACP, THC, Drug

NEW YORK, March 19, 2024 /PRNewswire/ -- Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer cannabis products, today announced it has signed a deal to acquire Northern Green Canada ("NGC"), a vertically integrated Canadian licensed cannabis producer focused primarily on expanding in the international market through its EU-GMP certification. NGC also partners with Canadian GACP cultivators to produce and distribute finished cannabis products to both the domestic and global markets.

Key Points:

NGC also partners with Canadian GACP cultivators to produce and distribute finished cannabis products to both the domestic and global markets.
By integrating NGC, Curaleaf can significantly increase its European margins while extending its global footprint across three continents: North America, Europe, and Australasia (Australia/New Zealand).
It allows Curaleaf to safeguard our position in Europe, enhancing our supply chain while increasing our margins.
Lisa McCormack, President and CEO of Northern Green Canada, said, "The NGC team is excited to become a part of the Curaleaf family.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on:

Sunday, March 10, 2024

Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points:

1
Committee on Herbal Medicinal Products (HMPC)
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition

Table of Content
1.
European Pharmacopoeia
SAWP

Scientific Advice Working Party

SmPC

Summary of Product Characteristics

THMP

Traditional Herbal Medicinal Product

TUR

Traditional Use Registration

WEU

Well-Established Use

Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Terminology of herbal medicinal products (Q&A 1-4)
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 4
Are food supplements regulated under the European Union (EU) pharmaceutical legislation
for (traditional) herbal medicinal products ((T)HMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Regulation of herbal medicinal products in the European Union (Q&A 511)
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
These countries have,
through the EEA agreement, adopted the complete Union acquis on medicinal products and are
consequently parties to the Union procedures.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Specific provisions for traditional herbal medicinal products (Q&A 1221)
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Nov. 2023
Answer 17
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 29
Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
(registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
Discussion with Member States intended to be
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.

Curio Wellness Certified Through Good Agriculture Collection Practices (GACP)

Retrieved on:

Wednesday, November 29, 2023

CGMP, Plant, Seed, World Health Organization, Climate, Patient, Operational excellence, GI, Health, SVP, Growth, GACP, Soil, Certification, Medicinal plants, Drug

TIMONIUM, Md., Nov. 29, 2023 /PRNewswire/ -- Curio Wellness, a cGMP-certified, vertically integrated cannabis company and market-leading innovator of health and wellness products has achieved completion of their Good Agriculture Collection Practices (GACP) certification. The World Health Organization-supported certification process is designed to ensure plant medicine companies employ proper quality, efficacy, and safety standards.

Key Points:

Market-leading innovator of cannabis products and technology maintains quality standard of excellence through rigorous, independent certification process
TIMONIUM, Md., Nov. 29, 2023 /PRNewswire/ -- Curio Wellness , a cGMP-certified, vertically integrated cannabis company and market-leading innovator of health and wellness products has achieved completion of their Good Agriculture Collection Practices (GACP) certification.
Curio Wellness is an established leader in operational excellence, devoted to providing adult-use consumers and medical patients with safe cannabis products and unparalleled quality.
Curio Wellness underwent audits of its quality, maintenance, operational systems, and agricultural practices, which were all deemed exceptional.
For more information on Curio Wellness products, partnerships, and manufacturing efforts, please visit https://curiowellness.com/ .