Ventilation

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

Retrieved on: 
Jeudi, avril 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

      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

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      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.

Orphan designation: branaplam Treatment of spinal muscular atrophy, 16/04/2018 Withdrawn

Retrieved on: 
Jeudi, avril 18, 2024
Eurostat, Diagnosis, Civil service commission, SMN, Brain, Atrophy, Gene, Weakness, Spinal muscular atrophy, Survival, Medicine, Disease, Paralysis, Novartis, Patient, Committee, Knowledge, Ventilation, Regulation, Brain cell, EMA, IRIS, Mouth, European, COMP, Spinal cord, Sponsor, European Commission, Spine, Safety, SMN1, Marketing, SMN2, Pharmaceutical industry

Orphan designation: branaplam Treatment of spinal muscular atrophy, 16/04/2018 Withdrawn

Key Points: 


Orphan designation: branaplam Treatment of spinal muscular atrophy, 16/04/2018 Withdrawn

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

Retrieved on: 
Jeudi, avril 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

      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.

EQS-News: Shelly Group accelerates expansion into professional market segments using globally established hardware and software standards

Retrieved on: 
Mercredi, avril 10, 2024
Automation, Heat, Light, Internet of things, Installation (computer programs), Air conditioning, Ventilation, DNA, Light + Building, KNX, Lighting, Ticker

Sofia / Munich, 13 March 2024 – Shelly Group AD (Ticker: SLYG / ISIN: BG1100003166 ) (“Shelly Group” / “the Company“), a provider of IoT and smart building solutions based in Sofia, Bulgaria, is accelerating its expansion into professional market segments.

Key Points: 
  • Sofia / Munich, 13 March 2024 – Shelly Group AD (Ticker: SLYG / ISIN: BG1100003166 ) (“Shelly Group” / “the Company“), a provider of IoT and smart building solutions based in Sofia, Bulgaria, is accelerating its expansion into professional market segments.
  • To this end, Shelly announced the integration of globally established hardware and software standards at Light + Building 2024, the world's leading expo for lighting and building technology.
  • In addition, Shelly is launching a new free tool that connects end customers in the German market with electricians for the installation of their products.
  • In this way, we increase customer and professional user loyalty and strengthen our market penetration and competitive position.“

49th Annual General Meeting of BELIMO Holding AG Approves All Motions

Retrieved on: 
Mercredi, avril 10, 2024
Committee, Heat, Independent, BELIMO Holding AG, Ventilation, SIX Swiss Exchange, Executive Committee, Annual general meeting, CHF, Remuneration, External auditor, Holding company

The 49th Annual General Meeting of BELIMO Holding AG was held on March 25, 2024.

Key Points: 
  • The 49th Annual General Meeting of BELIMO Holding AG was held on March 25, 2024.
  • The shareholders approved the proposed amendments to the Articles of Incorporation of BELIMO Holding AG, which are mainly in response to revisions to the Swiss company law.
  • Taking these amendments into account, the proposed maximum remuneration of the Board of Directors from January 1, 2024, to the 2024 Annual General Meeting, and from the 2024 Annual General Meeting to the 2025 Annual General Meeting, were approved.
  • The shares of BELIMO Holding AG have been traded on the SIX Swiss Exchange since 1995 (BEAN).

Endeavour Silver Delivers Strong Production in Q1 2024

Retrieved on: 
Mardi, avril 9, 2024
Silver, Gold, Inventory, EDR, Ventilation, TSX, Guanaceví, Mining

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Endeavour Silver Corp. (“Endeavour” or the “Company”) (NYSE: EXK; TSX: EDR) is pleased to report first quarter 2024 production of 1,460,006 silver ounces (oz) and 10,133 gold oz, for silver equivalent (1) (“AgEq”) production of 2.3 million oz.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Endeavour Silver Corp. (“Endeavour” or the “Company”) (NYSE: EXK; TSX: EDR) is pleased to report first quarter 2024 production of 1,460,006 silver ounces (oz) and 10,133 gold oz, for silver equivalent (1) (“AgEq”) production of 2.3 million oz.
  • Consolidated silver production decreased by 10% to 1,460,006 ounces in Q1 2024 compared to Q1 2023, driven by 7% lower silver production at the Guanaceví mine and 32% lower silver production at the Bolañitos mine.
  • Gold production increased by 8% to 10,133 ounces in Q1 2024 compared to Q1 2023 due to 17% higher gold production at the Bolañitos mine, offset by 2% lower gold production at the Guanaceví mine.
  • Bolañitos Q1 2024 throughput was 2% lower than Q1 2023 with 31% lower silver grades offset by 14% higher gold grades.

Osisko Announces Q1 2024 Geo Deliveries and Select Asset Updates

Retrieved on: 
Lundi, avril 8, 2024
Odyssey, Mining, Copper, Australian Securities Exchange, Osisko Gold Royalties, Silver, SSRP, GEOS, SAG, Gold, Senate, Annual report, Corporation, ASX, Acquisition, Mineral, Refused, CSA, Abitibi, Agnico Eagle, Ventilation, NSR, Resource

In addition, Osisko is excited to provide some select asset updates.

Key Points: 
  • In addition, Osisko is excited to provide some select asset updates.
  • Osisko earned 22,259 attributable gold equivalent ounces1 (“GEOs”) in the first quarter of 2024.
  • Osisko owns a 2% NSR royalty on the Ermitaño project and the Cumobabi property, including the Luna and Soledad Zones.
  • Osisko provides notice of the first quarter 2024 results and conference and webcast call details.

Dalrada Financial Corporation Subsidiary, Dalrada Home Corp., forms Advisory Board and Announces Inaugural Members

Retrieved on: 
Lundi, avril 8, 2024
Microsoft, SDG, Robertson Company, SAN, Knowledge, Air conditioning, Ventilation, Climate, Strategic planning, News, Architecture, HVAC, The Electric Company, Renewable energy, OTCQB

SAN DIEGO, April 08, 2024 (GLOBE NEWSWIRE) -- Dalrada Financial Corporation (OTCQB: DFCO, “Dalrada,” “the Company”), announced today the formation of the Dalrada Home Corp. Advisory Board and named its board members for the new wholly-owned subsidiary that will focus on the development and distribution of heat pumps for residential use.

Key Points: 
  • SAN DIEGO, April 08, 2024 (GLOBE NEWSWIRE) -- Dalrada Financial Corporation (OTCQB: DFCO , “Dalrada,” “the Company”), announced today the formation of the Dalrada Home Corp.
  • Advisory Board and named its board members for the new wholly-owned subsidiary that will focus on the development and distribution of heat pumps for residential use.
  • “The new advisory board brings together some of the brightest minds in the energy and sustainability fields.
  • Advisory Board comes during a time of accelerated global decarbonization efforts that increasingly target heat pumps to address ongoing climate and environmental challenges.

Dalrada Financial Corporation Announces Heat Pump Product Expansion, Enters Home and Residential Heat Pump Market

Retrieved on: 
Mardi, avril 2, 2024
IRS, Heat, SAN, Air conditioning, Climate, Ventilation, Research, News, Carbon, HVAC, OTCQB, Internal Revenue Service, Average revenue per user, Renewable energy

SAN DIEGO, April 02, 2024 (GLOBE NEWSWIRE) -- Dalrada Financial Corporation (OTCQB: DFCO, “Dalrada,” “the Company”), announced today the formation of Dalrada Home Inc., a wholly-owned subsidiary, to enter the booming home heat pump market by offering high-efficiency, cost-saving heat pumps specifically designed for residential use and hinting at further development.

Key Points: 
  • SAN DIEGO, April 02, 2024 (GLOBE NEWSWIRE) -- Dalrada Financial Corporation (OTCQB: DFCO , “Dalrada,” “the Company”), announced today the formation of Dalrada Home Inc. , a wholly-owned subsidiary, to enter the booming home heat pump market by offering high-efficiency, cost-saving heat pumps specifically designed for residential use and hinting at further development.
  • Dalrada’s range of impressive home heat pumps will fit the vast majority of American single-family homes from 850 square feet and above.
  • The expected product lineup will be announced in three to four weeks, with priority shipping available in approximately four weeks.
  • According to a 2023 report, the U.S. residential heat pump market was valued at over $13 billion , and is expected to reach nearly $30 billion by 2032.

Aduro Clean Technologies Welcomes a Multinational Building Materials Company into its Customer Engagement Program

Retrieved on: 
Mercredi, mars 27, 2024
ACT, Oil, Recycling, Polymer, Ventilation, Electronics, Cross, Client, Chemistry, Heart, CEP, HCT

LONDON, March 27, 2024 (GLOBE NEWSWIRE) -- Aduro Clean Technologies Inc. (“Aduro” or the “Company”) (CSE: ACT) (OTCQX: ACTHF) (FSE: 9D50), a Canadian technology company using the power of chemistry to transform lower value feedstocks, like waste plastics, heavy bitumen, and renewable oils, into resources for the 21st century, is excited to announce the onboarding of a leading, multinational building materials company (“MBM Company” or the “Client”) to its Customer Engagement Program (CEP).

Key Points: 
  • LONDON, March 27, 2024 (GLOBE NEWSWIRE) -- Aduro Clean Technologies Inc. (“Aduro” or the “Company”) (CSE: ACT) (OTCQX: ACTHF) (FSE: 9D50), a Canadian technology company using the power of chemistry to transform lower value feedstocks, like waste plastics, heavy bitumen, and renewable oils, into resources for the 21st century, is excited to announce the onboarding of a leading, multinational building materials company (“MBM Company” or the “Client”) to its Customer Engagement Program (CEP).
  • MBM Company, with extensive manufacturing operations across over 20 countries and a global distribution reach, generates multi-billion-dollar annual revenues.
  • The Client is recognized for its vast range of building materials and is dedicated to promoting sustainability through material circularity—emphasizing the recycling and reuse of materials across its product lines.
  • “Our dedication to providing customer-centric solutions is at the heart of what we do,” commented Ofer Vicus, CEO at Aduro.