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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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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

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104

4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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148
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
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

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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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?

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322

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325

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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.

Template for a European Union herbal monograph

Retrieved on:

Thursday, April 18, 2024

Key Points:

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.

OMAC and ei3 release report on EU Cybersecurity Compliance

Retrieved on:

Thursday, March 28, 2024

Civil service commission, Automation, Organization, OMAC, CRA, Risk assessment, Plastic, European Commission, Directive

New York, NY, March 28, 2024 (GLOBE NEWSWIRE) -- OMAC, the leading industry association for machine automation and control, has collaborated with ei3 to publish a report titled "Guidance for Business Leadership On EU Cybersecurity Regulations & Directives."

Key Points:

New York, NY, March 28, 2024 (GLOBE NEWSWIRE) -- OMAC, the leading industry association for machine automation and control, has collaborated with ei3 to publish a report titled "Guidance for Business Leadership On EU Cybersecurity Regulations & Directives."
The document provides practical guidance and best practices for complying with the European Commission's new Cyber Resilience Act (CRA), which mandates stringent cybersecurity measures for all digital products sold in EU markets.
The report comprehensively covers topics outlined in the CRA, including the legislative progress, affected industries and entities, guidelines for product design, compliance responsibilities throughout the product lifecycle, best practices for product development, and providing evidence of CRA compliance.
OMAC anticipates cybersecurity regulations will continue to impact automation around the globe, and we must prepare our members and the industries we serve for that impact.”
Visit https://ei3.com/ei3-and-omac-publish-report-on-eu-cra-guideline-compliance/ to download the report and ensure your business achieves CRA compliance.

Navigating "Green Claims" Regulatory Change with Lenzing

Retrieved on:

Thursday, March 21, 2024

Climate change, European Parliament, Lenzing AG, EU Ecolabel, Service, European, Textile industry, Directive

LENZING, Austria, March 21, 2024 /PRNewswire/ -- Due to increasing concerns around climate change, consumers are constantly seeking ways to contribute positively.

Key Points:

LENZING, Austria, March 21, 2024 /PRNewswire/ -- Due to increasing concerns around climate change, consumers are constantly seeking ways to contribute positively.
Lenzing Group, a leading global producer of wood-based specialty fibers, is committed to working with the textile value chain to navigate through the changing regulatory landscape and supporting consumers to make informed choices.
AT/016/001) in 2002, Lenzing continues to focus on enhancing its impact on the value chain, driving systematic change and advancing circularity.
Given the evolving consumer needs and regulatory landscapes, Harold underscored the importance for companies like Lenzing to stay abreast of changes and consumer behaviors.

Navigating "Green Claims" Regulatory Change with Lenzing

Retrieved on:

Thursday, March 21, 2024

Climate change, European Parliament, Lenzing AG, EU Ecolabel, Service, European, Textile industry, Directive

LENZING, Austria, March 21, 2024 /PRNewswire/ -- Due to increasing concerns around climate change, consumers are constantly seeking ways to contribute positively.

Key Points:

LENZING, Austria, March 21, 2024 /PRNewswire/ -- Due to increasing concerns around climate change, consumers are constantly seeking ways to contribute positively.
Lenzing Group, a leading global producer of wood-based specialty fibers, is committed to working with the textile value chain to navigate through the changing regulatory landscape and supporting consumers to make informed choices.
AT/016/001) in 2002, Lenzing continues to focus on enhancing its impact on the value chain, driving systematic change and advancing circularity.
Given the evolving consumer needs and regulatory landscapes, Harold underscored the importance for companies like Lenzing to stay abreast of changes and consumer behaviors.

First Quantum Minerals Announces Pricing Of $1,600 Million Senior Secured Second Lien Notes Offering

Retrieved on:

Friday, February 23, 2024

Prospectus, Financial services, Person, Note, Investment, News, TSX, Advertising, Sale, Nature, Communication, Order, Surety, Legislation, Directive, Finance, Offering, Security (finance)

TORONTO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- First Quantum Minerals Ltd. (“First Quantum” or the “Company”) (TSX: FM) announces that it has successfully completed the pricing of its offering (the “Offering”) of $1,600 million aggregate principal amount of 9.375% senior secured second lien due 2029 (the “Notes”). The issue price of the Notes is 100.000%.

Key Points:

TORONTO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- First Quantum Minerals Ltd. (“First Quantum” or the “Company”) (TSX: FM) announces that it has successfully completed the pricing of its offering (the “Offering”) of $1,600 million aggregate principal amount of 9.375% senior secured second lien due 2029 (the “Notes”).
The Notes will be guaranteed, jointly and severally, on a senior basis by the guarantors (the “Guarantors”) described in the offering memorandum for the Offering (the “Guarantees”).
The Guarantees will rank equally in right of payment to all existing and future senior debt of the Guarantors.
The Company intends to apply the net proceeds from the Offering towards the redemption of all of its outstanding senior notes due 2025 and 2026.

First Quantum Announces $1,600 Million Senior Secured Second Lien Notes Offering As Part of Comprehensive Refinancing

Retrieved on:

Wednesday, February 21, 2024

TORONTO, Feb. 21, 2024 (GLOBE NEWSWIRE) -- First Quantum Minerals Ltd. (“First Quantum” or “the Company”) (TSX: FM) announces that it is launching an offering of $1,600 million aggregate principal amount of senior secured second lien notes due 2029 (the “Notes”).

Key Points:

TORONTO, Feb. 21, 2024 (GLOBE NEWSWIRE) -- First Quantum Minerals Ltd. (“First Quantum” or “the Company”) (TSX: FM) announces that it is launching an offering of $1,600 million aggregate principal amount of senior secured second lien notes due 2029 (the “Notes”).
The Notes will be guaranteed, jointly and severally, on a senior basis by certain guarantors as described in the offering memorandum (the “Guarantees”).
The Company intends to apply the net proceeds from the sale of the Notes towards the redemption of all of its outstanding senior notes due 2025 and 2026.
The Company has prepared an offering memorandum which will be made available to selected prospective purchasers of the Notes.

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.

Ekran System Unveils Powerful Solutions to Elevate Organizations' NIS2 Compliance

Retrieved on:

Monday, February 12, 2024

Online Privacy, Data Management, Security, Technology, Software, Networks, System, Multimedia, Ebook, Risk management, Regulatory compliance, Risk, Directive, Organization, Ultimate, Face, Medical device

Ekran System, a leader in insider risk management solutions, announces groundbreaking strategies to empower organizations in mastering NIS2 compliance.

Key Points:

Ekran System, a leader in insider risk management solutions, announces groundbreaking strategies to empower organizations in mastering NIS2 compliance.
View the full release here: https://www.businesswire.com/news/home/20240212299236/en/
Comprehensive NIS2 Compliance Guide : Ekran System introduces the Ultimate NIS2 Compliance Guide, providing actionable insights for organizations to effortlessly unravel NIS2 requirements.
Integration with Ekran System: Explore how Ekran System's insider risk management solutions seamlessly align with NIS2 requirements, offering organizations the opportunity to optimize their compliance journey.
The unveiling of the Ultimate NIS2 Compliance Guide and the seamless integration of insider risk management solutions reaffirm Ekran System's commitment to leading the charge in the insider risk landscape.