Temperature

Kourtney Kardashian Barker isn’t the first to drink breast milk – but we know surprisingly little about its adult health benefits

Retrieved on: 
Jeudi, avril 25, 2024

Her comment attracted shock, horror and disgust from many social media users, but it’s not the first time Kardashian Barker has used her milk as medicine.

Key Points: 
  • Her comment attracted shock, horror and disgust from many social media users, but it’s not the first time Kardashian Barker has used her milk as medicine.
  • In 2013, she applied her breast milk to her sister Kim Kardashian’s leg in an effort to heal a patch of psoriasis.
  • But by drinking her own breast milk, the eldest Kardashian sister helped promote a health trend already steeped in centuries of medical history.
  • One thing that is not recommended by any health organisation is adult consumption of human milk.

History of human milk as medicine

  • Many healers of the day also recommended treating eye infections with human milk, which was known as “whitened blood”.
  • We know that human milk contains many components which can be effective as antimicrobials – lactoferrin and antimicrobial peptides, for example.

Bodybuilders think breast is best

  • Human milk is also used by some bodybuilders to lose fat and bulk up.
  • This has created an online marketplace allowing easy access to breast milk.
  • The 2020 Netflix series (Un)Well featured an episode focused on the safety and ethics of breast milk for bodybuilding.

Lack of research into potential benefits

  • Considering human milk feeds most of the world’s population for the first six months of their life, it is a surprisingly understudied area.
  • Researchers have shown preliminary evidence that specific components of human milk could have antimicrobial activity against pathogens that infect adults.
  • If she does, there are many human milk banks in her native California that would welcome her donation.


Simon Cameron receives funding from UK Research and Innovation for work related to human milk microbiology and composition.

Ukraine war: Putin’s plan to fire up Zaporizhzhia power plant risks massive nuclear disaster

Retrieved on: 
Jeudi, avril 25, 2024

Recent reports of a series of drone strikes on Ukraine’s Zaporizhzhia Nuclear Power Plant (ZNPP) have demonstrated the serious safety and security concerns at Europe’s largest nuclear power station.

Key Points: 
  • Recent reports of a series of drone strikes on Ukraine’s Zaporizhzhia Nuclear Power Plant (ZNPP) have demonstrated the serious safety and security concerns at Europe’s largest nuclear power station.
  • It has not been confirmed who is responsible for the strikes.
  • Both Russia, which occupied ZNPP in March 2022, and Ukraine have pointed the finger at each other.

Drones strike targets

  • Attacks have included a drone strike on the oxygen and nitrogen production facility, two on the training centre and a drone shot down above a turbine hall.
  • It is clearly part of the power plant, yet is isolated and likely contains little to no nuclear material, meaning the risk of resulting nuclear accident is relatively low.
  • The IAEA has repeatedly stated that there can be no benefit to any party from a nuclear disaster at the plant.
  • Ukrainian personnel still working at ZNPP have claimed that Russia has turned the plant into a military base.
  • The IAEA continues to call for restraint and for all military activity to be halted in the vicinity of the plant.

A risky restart

  • This means the cooling water in the reactor is below 100°C and at atmospheric pressure.
  • This is safer than the previous state of “hot shutdown”, but a restart would be far worse than either of these.
  • Putting ZNPP, a plant still on the front line of an armed conflict, into operation would therefore be highly risky.
  • Chernobyl Remembrance Day commemorates the world’s worst nuclear disaster, which occurred in 1986 in what is today Ukraine.


Ross Peel is affiliated with the Centre for Science & Security Studies at King's College London.

The weather experiment that really flooded Dubai

Retrieved on: 
Jeudi, avril 25, 2024

That was the story last week when more than a year’s worth of rain fell in a day on the Arabian Peninsula, one of the world’s driest regions.

Key Points: 
  • That was the story last week when more than a year’s worth of rain fell in a day on the Arabian Peninsula, one of the world’s driest regions.
  • Desert cities like Dubai in the United Arab Emirates (UAE) suffered floods that submerged motorways and airport runways.
  • Every Wednesday, The Conversation’s environment editor writes Imagine, a short email that goes a little deeper into just one climate issue.
  • Richard Washington, a professor of climate science at the University of Oxford, has seen the inside of a storm.
  • To confirm if cloud seeding really could breed record-breaking rain, he once boarded an aeroplane bound for a thundercloud over the South Africa-Mozambique border.

What caused the flood?

  • But by flying a lot of missions, half with cloud seeding and half without, and measuring rainfall between the two, meteorologists eventually showed that cloud seeding did modify rain rates in some storms.
  • That’s not what caused Dubai’s floods though.
  • Their approach is to fire hygroscopic (water-attracting) salt flares from aircraft into warm cumuliform clouds,” Washington says.
  • “So could seeding have built a huge storm system the size of France?
  • Let’s be clear, that would be like a breeze stopping an intercity train going at full tilt.

The experiment of our lives

  • Although last week’s deluge was unusual, the Arabian Peninsula does tend to receive more of its precipitation in heavy bursts than steady showers.
  • What is likely to kill more people as temperatures rise in this part of the world is not water, but heat.
  • At this threshold the air is so hot and humid that you cannot lower your temperature to a safe level by sweating.
  • Peter Irvine, a lecturer in earth sciences at UCL, proposes dimming the sun by pumping microscopic particles into the upper atmosphere to reflect some of its rays.
  • These layers of gases that surround our planet have nurtured life by keeping temperatures stable and harmful radiation out.
  • Read more:
    Time is running out on climate change, but geoengineering has dangers of its own

    As humanity contemplates another large-scale experiment in our atmosphere, there is another, even bigger one, waiting to be resolved.

Vaping now more common than smoking among young people – and the risks go beyond lung and brain damage

Retrieved on: 
Jeudi, avril 25, 2024

This echoes research that has found the popularity of vaping among young people in the UK has surged in recent years.

Key Points: 
  • This echoes research that has found the popularity of vaping among young people in the UK has surged in recent years.
  • But vaping comes with many risks to young people, including harm to the lungs and brain.
  • Young people who vape may be more likely to start smoking and find it harder to quit any nicotine use at all.
  • And using vaping products alongside other products containing nicotine, like cigarettes, for example, may be even worse for their health.

Hidden risks

  • There are many less obvious risks to vaping too.
  • The chemicals in vape liquids – including various toxins, heavy metals and possibly even radioactive polonium – may be harmful.
  • This could be because of the specific mix of ingredients different brands put in the vape liquid.
  • Even if a vape liquid is advertised as being nicotine-free, it might still contain chemicals called nitrosamines, which are known to cause cancer.

Is a ban on disposable vapes enough?

  • The forthcoming ban on disposable vapes in England, Scotland and Wales may not be enough to deal with the problem.
  • With more than 400 vape brands already on the market, a more comprehensive approach is needed.


Amira Guirguis does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Chemical pollutants can change your skin bacteria and increase your eczema risk − new research explores how

Retrieved on: 
Mardi, avril 23, 2024

Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.

Key Points: 
  • Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.
  • Some studies have found rates of eczema in developing nations to be over thirtyfold lower compared with industrialized nations.
  • Scientists know that factors such as diets rich in processed foods as well as exposure to specific detergents and chemicals increase the risk of developing eczema.
  • Living near factories, major roadways or wildfires increase the risk of developing eczema.

There’s something in the air

  • Then we looked at databases from the U.S. Environmental Protection Agency to see which chemicals were most common in those areas.
  • Diisocyanates were first manufactured in the U.S. around 1970 for the production of spandex, nonlatex foam, paint and polyurethane.
  • The manufacture of xylene also increased around that time, alongside an increase in the production of polyester and other materials.
  • After 1975, when all new cars became outfitted with a new technology that converted exhaust gas to less toxic chemicals, isocyanate and xylene both became components of automobile exhaust.
  • How directly exposing mice to these toxins compares to the typical levels of exposure in people is still unclear.

Skin microbiome and pollution

  • Every person is coated with millions of microorganisms that live on the skin, collectively referred to as the skin microbiome.
  • You’ve probably seen moisturizers and other skin products containing ceramides, a group of lipids that play an important role in protecting the skin.
  • To see which toxins could prevent production of the beneficial lipids that prevent eczema, my team and I used skin bacteria as canaries in the coal mine.
  • Lysine helps protect the bacteria from the harms of the toxins but doesn’t provide the health benefits of ceramides.
  • Bacteria that help keep skin healthy could live on any fabric, but, just as with air pollution, the amount of beneficial lipids they made dropped to less than half the levels made when grown on fabrics like cotton.

Addressing pollution’s effects on skin

  • Detectors capable of sensing low levels of isocyanate or xylene could help track pollutants and predict eczema flare-ups across a community.
  • Better detectors can also help researchers identify air filtration systems that can scrub these chemicals from the environment.
  • In the meantime, improving your microbial balance may require avoiding products that limit the growth of healthy skin bacteria.
  • I believe that it may one day allow us to get back to a time when these diseases were uncommon.


Ian Myles receives funding from the Department of Intramural Research at the National Institute of Allergy and Infectious Diseases. He is the author of, and receives royalties for, the book GATTACA Has Fallen: How population genetics failed the populace. Although he is the co-discoverer of Roseomonas mucosa RSM2015 for eczema, he has donated the patent to the public and has no current conflict of interest for its sales.

The ‘devil comet’ 12P/Pons-Brooks has finally become visible from Australia. What can we expect?

Retrieved on: 
Vendredi, avril 19, 2024

Now it’s our turn, as comet 12P/Pons–Brooks is creeping into view for the southern hemisphere.

Key Points: 
  • Now it’s our turn, as comet 12P/Pons–Brooks is creeping into view for the southern hemisphere.
  • Comet Pons–Brooks is visible to the naked eye, but only if you know where to look.

Why do people call it the ‘devil comet’?

  • It takes around 71 years to orbit the Sun, making the comet’s visits to the inner Solar System a rare treat for us here on Earth.
  • At its heart (its nucleus), Pons–Brooks is a dirty snowball around 34 kilometres in diameter.
  • As the comet came swinging back towards us in its orbit, astronomers spotted it back in 2020.
  • Instead, it produces several large outbursts of activity, each time, emitting vast amounts of gas and dust in a very short period of time before settling down again.
  • The solar wind pushed the resulting dust, gas and debris away from the Sun, giving the comet an unusual appearance.

Where (and when) should I look?

  • It is currently visible low in the western sky after sunset, albeit almost lost in the glow of twilight.
  • In the next few weeks, the comet will slowly climb higher in the evening sky.
  • The two videos below show the location of the comet’s head at 6:30pm from mid-April through to mid-June, as seen from Toowoomba and Melbourne.
  • The comet’s tails point away from the Sun – so will rise upwards from the western horizon in the evening sky.

But wait… there’s more!

  • That comet, C/2023 A3 (Tsuchinshan-ATLAS), was discovered in January 2023, and astronomers soon realised it has the potential to become truly dazzling.
  • Comet behaviour is hard to predict, so take the following with a pinch of salt, but things still look really promising.
  • Current predictions suggest Tsuchinshan-ATLAS will be at least as bright as the brightest stars in late September and early October this year.


Jonti Horner does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Scotland is ditching its flagship 2030 climate goal – why legally binding targets really matter

Retrieved on: 
Jeudi, avril 18, 2024

The target was statutory, meaning it had been set in law in the Emissions Reduction Targets Act of 2019.

Key Points: 
  • The target was statutory, meaning it had been set in law in the Emissions Reduction Targets Act of 2019.
  • Scotland is still subject to the 2030 carbon target for the UK as a whole.
  • The consistent implementation of the existing targets, in other words, is the difference between meeting the Paris objectives and condemning the planet to dangerous climate change.

Legally (but not literally) binding

  • In 2017, Sweden was the first major economy to enact a statutory net zero target.
  • Its net zero target is complemented by a series of intermediate steps: five-yearly carbon budgets, which are also legally binding.
  • Legal scholars have long known that, even though the targets are legally binding, they would be difficult to enforce against an unwilling government.

Governments in the dock

  • The plaintiff was the environmental law charity ClientEarth, which remains dissatisfied with the strategy and returned to court in February 2024.
  • If successful, such a move would be the latest in a series of court cases in which judges have ordered governments to scale up their climate ambitions.
  • The political embarrassment of missing a statutory target, or being subject to a court case, can focus the mind.
  • A review of the UK Climate Change Act found that civil servants were petrified about the threat of a judicial review.
  • Scotland’s decision to abandon its 2030 climate ambition is the most brazen violation of a statutory climate target yet.


Don’t have time to read about climate change as much as you’d like?
Get a weekly roundup in your inbox instead. Every Wednesday, The Conversation’s environment editor writes Imagine, a short email that goes a little deeper into just one climate issue. Join the 30,000+ readers who’ve subscribed so far.
Sam Fankhauser receives funding from the University of Oxford's Strategic Research Fund for Oxford Net Zero and the UK Economic and Social Research Council (ESRC) for the Place-based Climate Action Network (PCAN).

Things that go buzz in the night – our global study found there really are more insects out after dark

Retrieved on: 
Jeudi, avril 18, 2024

We searched for meaningful comparisons of insect activity by day and by night.

Key Points: 
  • We searched for meaningful comparisons of insect activity by day and by night.
  • Our global analysis confirms there are indeed more insects out at night than during the day, on average.
  • And now we know for sure, we can make more strident efforts to conserve insects and preserve their vital place in the natural world.

Building a global dataset of sleepless nights

  • We narrowed these down to studies using methods that would not influence the results.
  • For instance, we excluded studies that collected insects by using sweep nets or beating branches, as these methods can capture resting insects along with active ones.
  • These include pitfall traps (for crawling insects), flight interception traps (for flying insects) and aquatic drift nets (for swimming insects).


Eventually, we honed in on 99 studies published between 1959 and 2022. These studies spanned all continents except Antarctica and encompassed a wide range of habitats on both land and water.

What did we find?


We found more mayflies, caddisflies, moths and earwigs at night. On the other hand, there were more thrips, bees, wasps and ants during the day.

  • In these aquatic areas, there could be twice as many insects active during the night.
  • In contrast, land-based insects were generally more active during the day, especially in grasslands and savannas.
  • We also found insects were more active at night in warmer parts of the globe, where there are higher maximum temperatures.

Findings underscore the threats to nocturnal insects


Insects perform many vital “ecosystem services” such as pollination, nutrient cycling and pest control. Many of these services may be provided at night, when more insects are active. This means we need to curtail some of our own activities to support theirs. For instance, artificial lighting is detrimental to nocturnal insects.

  • In the hottest regions of the globe such as the tropics, the warming trend may further reduce the activity of nocturnal insects that struggle to cope with heat.
  • Read more:
    Insects will struggle to keep pace with global temperature rise – which could be bad news for humans


The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Jeudi, avril 18, 2024

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

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      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

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      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

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      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

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

Retrieved on: 
Jeudi, avril 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

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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

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      7.

    • Where possible, stable varieties and cultivars naturally
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      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:

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      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.

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      EMA/HMPC/246816/2005

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      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
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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.