Committee

Press release - “Parliament 2024”: a more modern and efficient Parliament after the elections

Retrieved on: 
Jeudi, avril 18, 2024
Emergency, Parliament, Conference, Exercise, EPP, European Parliament, Framework agreement, Committee, Policy, House, Commission, Council, EP, TFEU, Legislation

The new internal rules will strengthen Parliament’s working methods, its institutional role, and its capacity to act.Committee on Constitutional Affairs Source : © European Union, 2024 - EP

Key Points: 


The new internal rules will strengthen Parliament’s working methods, its institutional role, and its capacity to act.Committee on Constitutional Affairs Source : © European Union, 2024 - EP

Press release - European Parliament Press Kit for the Special European Council of 17 and 18 April 2024

Retrieved on: 
Jeudi, avril 18, 2024
Gas, Hamas, Face, ACI, Committee, Special, Seal, S&D, Parliament, Council, Investment, Honey, European Commission, EP, Data Act, Artificial intelligence, Policy, Legislation, Wildfire, Research, War, Delegation, Communication, Speech, Democracy, CFD, Aggression, Poultry, Partnership, Risk, Outline, City, MFF, Brexit, Safety, GAEC, GUE/NGL, SMEI, Pilar del Castillo, Waste, SME, STEP, Weather, Person, Emergency, Electricity, Annual report, Climate change, International trade, Acceleration, Intelligence, Act, Internet, Coercion, AI, Crime, Private sector, Commission, Common Agricultural Policy, Nuclear energy, Security, Single market, Grid, Violence, Mining, Civil service commission, Punishment, EUR, Cyber, Farmer, European Council, Artificial Intelligence Act, EPP, Recycling, European Parliament, COVID-19, Common, CAP, Flood, Hydrogen, EBS, European Defence Fund, Collection, International law, Defense, Government

In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP

Key Points: 


In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Retrieved on: 
Jeudi, avril 18, 2024
Eucalyptus oil, Bronchitis, Spasm, Seizure, System, Risk, Inflammation, Patient, Lung, Monograph, Committee, Inhalation, Steam, Herbal medicine, Date, Asthma, Heart failure, Plant, Mouth, Infection, Skin, Fever, Myalgia, Water, Larynx, Medicine, Dietary supplement

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Key Points: 


Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Herbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalised

Retrieved on: 
Jeudi, avril 18, 2024
Cerastium, Date, Urinary system, System, Patient, Monograph, Committee, Urine, Mouth, Heart, Herbal medicine, Flower, Medicine, Dietary supplement

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
  • Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
  • Key facts
    - Latin name
    - Pilosellae herba cum radice
    - English common name
    - Mouse-ear hawkweed
    - Botanical name
    Hieracium pilosella L.
    - Therapeutic area
    - Urinary tract and genital disorders
    - Status
    - F: Assessment finalised
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph

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

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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

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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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      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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      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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      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

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      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
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      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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      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: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Retrieved on: 
Jeudi, avril 18, 2024
Eurostat, Diagnosis, Civil service commission, Absorption, Lower respiratory tract infection, Exercise, Cell, Infection, DSM-IV codes, Inflammation, Patient, Committee, Cystic fibrosis, Knowledge, Digestion, Regulation, Bacteria, Food, EMA, IRIS, Anti-inflammatory, Mucus, CB2, European, COMP, Pancreas, Sponsor, Ivacaftor, European Commission, Safety, CFTR, Marketing, Medicine, Pharmaceutical industry

Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Key Points: 


Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Orphan designation: mRNA encoding the human CFTR gene Treatment of cystic fibrosis, 19/02/2024 Positive

Retrieved on: 
Jeudi, avril 18, 2024
Patient, Committee, Arcturus Therapeutics, Messenger, EMA, IRIS, European, Therapy, COMP, European Commission, CFTR, Marketing, Cystic fibrosis, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of cystic fibrosis in the European Union on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: (4R)-3-(4-fluoro-2-hydroxyphenyl)-4-methyl-4,5-dihydro-1H-pyrazole-1-carboximidamide hydrochloride Treatment of systemic sclerosis, 12/01/2024 Positive

Retrieved on: 
Jeudi, avril 18, 2024
Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of systemic sclerosis on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Human coagulation factor X Treatment of acquired factor X deficiency, 12/01/2024 Positive

Retrieved on: 
Jeudi, avril 18, 2024
European Commission, Committee, COMP, IRIS, EMA, Pharmaceutical industry

EU/3/23/2886 - orphan designation for treatment of acquired factor X deficiency

Key Points: 
  • EU/3/23/2886 - orphan designation for treatment of acquired factor X deficiency
    Human coagulation factor X
    OrphanHuman
    BPL Bioproducts Laboratory GmbH
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: golcadomide hydrochloride Treatment of diffuse large B-cell lymphoma, 12/01/2024 Positive

Retrieved on: 
Jeudi, avril 18, 2024
B-cell lymphoma, Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of diffuse large B-cell lymphoma on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: