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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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104

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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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
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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

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.

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.

Equus Announces Fourth Quarter Net Asset Value

Retrieved on:

Wednesday, April 3, 2024

Acquisition, Natural gas, Investment, Hydrocarbon

The following were the principal contributors to the changes in fair value of the Company’s portfolio holdings in the fourth quarter of 2023:

Key Points:

The following were the principal contributors to the changes in fair value of the Company’s portfolio holdings in the fourth quarter of 2023:
Increase in Fair Value of Morgan E&P.
Decrease in Fair Value of Equus Energy.
During the fourth quarter of 2023, the fair value of the Company’s holding in Equus Energy, LLC (“Equus Energy”) decreased $5.5 million, from $15.5 million to $10.0 million, largely as a consequence of the exclusion of certain gas reserves held by Equus Energy that had become uneconomic to develop as a result of changes in the forward pricing curve for natural gas.
The Company received advice and assistance from a third-party valuation firm to support its determination of the fair value of its investments in Morgan and Equus Energy.

SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Investors It Has Filed a Complaint to Recover Losses Suffered by Next Bridge Hydrocarbons, Inc. Shareholders and Sets a Lead Plaintiff Deadline of May 14, 2024

Retrieved on:

Friday, March 15, 2024

NBH, Telephone, District court, Metamaterial, Meta, LLP, Hydrocarbon, Court, Person

You are hereby notified that the class action lawsuit Targgart v. Next Bridge Hydrocarbons, Inc., et al.

Key Points:

You are hereby notified that the class action lawsuit Targgart v. Next Bridge Hydrocarbons, Inc., et al.
1:24-cv-01927) has been commenced in the United States District Court for the Eastern District of New York.
The complaint alleges that NBH filed a registration statement in connection with its spin-off from Meta Materials that contained false and/or materially misleading statements.
The statements at issue concern the value of the Company’s oil and gas assets and NBH’s transactions with related parties.

Profire Energy Reports Financial Results for Fourth Quarter and Full Fiscal Year 2023

Retrieved on:

Wednesday, March 13, 2024

Profire Energy, CFO, G&A, Public expenditure, Hydrocarbon, Traction, Safety, Depreciation, Total, Video game

Total revenues for the period equaled $14.4 million, compared to $14.8 million in the third quarter of 2023 and $14.0 million in the prior-year quarter.

Key Points:

Total revenues for the period equaled $14.4 million, compared to $14.8 million in the third quarter of 2023 and $14.0 million in the prior-year quarter.
Gross profit was $7.8 million, compared to $7.5 million in the third quarter of 2023 and $6.6 million in the prior-year quarter.
Gross margin was 54% of revenues, compared to 50.4% of revenues in the prior quarter and 47.0% of revenues in the fourth quarter of 2022.
Total operating expenses were $5.0 million, compared to $4.9 million in the third quarter of 2023 and $4.3 million in the year-ago quarter.

Pembina Pipeline Corporation Announces Significant Milestones Achieved on Cedar LNG

Retrieved on:

Thursday, April 4, 2024

In addition, Pembina has executed an identical bridging agreement with Cedar LNG for 1.5 mpta.

Key Points:

In addition, Pembina has executed an identical bridging agreement with Cedar LNG for 1.5 mpta.
Cedar LNG has secured a 20-year take-or-pay, fixed toll contract with ARC Resources for 1.5 million mtpa of LNG.
"We are proud to partner with Cedar LNG, the Haisla Nation and Pembina Pipeline who share our commitment to responsible energy development."
Once operational, Cedar LNG is expected to generate annual run-rate adjusted EBITDA of US$200 million to US$260 million, net to Pembina.

Global Hydrocarbons Accounting Solution Industry Report 2024- 2032 Featuring CGI, EnergySys, Infosys, P2 Energy Solutions, Quorum Business Solutions, SAP, and Wipro

Retrieved on:

Tuesday, March 19, 2024

Cloud, Organization, Pressure, Component, Forecasting, Growth, Data analysis, Internet of things, Software, Artificial intelligence, Carbon, Investment, Hydrocarbon, Cloud computing, Traction, Water, Natural gas, Machine learning, Oil

The global hydrocarbons accounting solution market size reached US$ 533.2 million in 2023.

Key Points:

The global hydrocarbons accounting solution market size reached US$ 533.2 million in 2023.
Hydrocarbons accounting solutions provide a comprehensive means to track, analyze, and report on hydrocarbon-related data, ensuring compliance with environmental standards.
What is the impact of each driver, restraint, and opportunity on the global hydrocarbons accounting solution market?
Who are the key players/companies in the global hydrocarbons accounting solution market?

A Major Gas Find Could Upend European Energy Markets

Retrieved on:

Thursday, March 14, 2024

LONDON, March 14, 2024 /PRNewswire/ -- As Europe realizes the full risk of relying on foreign oil and gas, it could soon find relief coming from an unexpected source. That's because, after years of leaning on cheap Russian gas, geopolitical shifts have changed the equation. Both the war in Ukraine and simple economics have forced the EU to pivot from strict green energy policies. Companies mentioned in this release include: Chevron Corporation (NYSE: CVX), ExxonMobil Corporation (NYSE: XOM), ConocoPhillips (NYSE: COP), Talos Energy Inc. (NYSE: TALO), Cheniere Energy, Inc. (NYSE: LNG).

Key Points:

' And The Washington Post announced recently, 'Amid energy crisis, EU says gas can sometimes be 'green.''
The message is clear: Europe is scrambling to diversify its energy sources and achieve true energy independence.
That's why one Canadian energy company, MCF Energy ( MCF .V; MCFNF .QX), is on a mission to help secure Europe's energy independence and explore these long-ignored assets.
ConocoPhillips (NYSE: COP) has adeptly balanced its energy portfolio between natural gas and oil, reflecting a nuanced understanding of the world's changing energy consumption trends.

Europe's Secret Weapon In Its Energy War With Russia

Retrieved on:

Tuesday, March 12, 2024

While Germany has struggled strategically and politically in its effort to balance its climate change goals with its energy security needs, Austria has not only refrained from turning off the Russian gas taps—opting for a gradual approach--but it's also recently made the country's largest natural gas discovery in 40 years.

Key Points:

These shallow wells, cheap to drill, from proven, previously drilled holes could translate into quick cash flow for MCF Energy.
MCF Energy has adopted a laser focus on Europe's energy security requirements, which is most significantly emphasized by Germany, the largest economy of the European Union.
MCF Energy ( MCF.V ; MCFNF.QX ) believes the answer is found in domestic natural gas, the increasingly accepted bridge fuel for a green energy transition.
In Europe, where the energy landscape is rapidly evolving, Halliburton's contributions to oil and gas exploration and production are invaluable.

Europe's Secret Weapon In Its Energy War With Russia

Retrieved on:

Tuesday, March 12, 2024

While Germany has struggled strategically and politically in its effort to balance its climate change goals with its energy security needs, Austria has not only refrained from turning off the Russian gas taps—opting for a gradual approach--but it's also recently made the country's largest natural gas discovery in 40 years.

Key Points:

These shallow wells, cheap to drill, from proven, previously drilled holes could translate into quick cash flow for MCF Energy.
MCF Energy has adopted a laser focus on Europe's energy security requirements, which is most significantly emphasized by Germany, the largest economy of the European Union.
MCF Energy ( MCF.V ; MCFNF.QX ) believes the answer is found in domestic natural gas, the increasingly accepted bridge fuel for a green energy transition.
In Europe, where the energy landscape is rapidly evolving, Halliburton's contributions to oil and gas exploration and production are invaluable.