QRD

Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

Retrieved on: 
tisdag, maj 28, 2024
Fertility, PBPK, International Council, Toxicity, Marketing, Risk, Birth, Medication package insert, Clinical trial, Vaccination, NOAEL, Woman, Causality, Lactation, Interest, Teratology, Health care, IMI, Human, Reproduction, GVP, Harmonization, Technical, Communication, SWP, Risk assessment, Committee, PCWP, Literature, Female, Health, PRAC, QRD, Safety, Animal, Breast milk, Bibliography, PPP, Child, Toxicology, Sample size determination, Patient, North American Menopause Society, Conception, DSM-IV codes, Medication, Innovation, Pregnancy, Medicine, EMA, ICH, Knowledge, DART, European Medicines Agency, CHMP, Birth control

13

Key Points: 
    • 13
      Keywords

      Pregnancy, breastfeeding, lactation, fertility, reproductive toxicity,
      teratogenicity, contraindication, clinical assessment, non-clinical
      assessment, risk assessment, labelling, Summary of Product Characteristics
      (SmPC).

    • Introduction

      17

      The PRAC and CHMP work plans for 2023 [1,2] list several activities intended to implement guidance

      18

      on ?Special populations and products?.

    • This includes further optimising close cooperation between

      19

      these two Committees for the revision of the ?CHMP Guideline on risk assessment of medicinal products

      20

      on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)? [3].

    • Further, there is guidance on how to communicate the potential or identified risk through

      29

      the Summary of Product Characteristics (SmPC).

    • 46

      Most data regarding human pregnancy exposures are collected after marketing authorisation by

      47

      spontaneously reported post-authorisation data, in patient/pregnancy registries, and via

      48

      epidemiological studies undertaken in such data sources [7].

    • Such data sources are available in the

      49

      EU, as compiled by the European Network of Centres for Excellence in Pharmacovigilance and

      50
      51

      Pharmacoepidemiology (ENCePP) 1.

    • The development of
      1
      2

      http://www.encepp.eu/structure/documents/Data_sources_for_medicines_in_p...
      https://database.ich.org/sites/default/files/ICH_E21_Final_Concept_Paper...

      Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 2/6

      57

      physiologically based pharmacokinetic (PBPK)-modelling approaches may facilitate the prediction of

      58

      drug exposure in breast milk based on scarce data.

    • Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III ? Pregnancy

      70

      prevention programme and other pregnancy-specific risk minimisation measures

      71

      (EMA/608947/2021) 4,

      72

      3.

    • Recommendation

      137

      The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk

      138

      Assessment Committee (PRAC) recommends the revision of the current ?Guideline on risk assessment

      139

      of medicinal products on human reproduction and lactation: from data to labelling? considering the

      140

      issues identified above.

    • Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 5/6

      167

      [2] EMA/CHMP.

    • Guideline on risk assessment of medicinal products on human reproduction and

      171

      lactation: from data to labelling (EMEA/CHMP/203927/2005).

    • 188

      Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 6/6

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Retrieved on: 
torsdag, april 25, 2024
Artesunate, QRD, Cysteamine, Daunorubicin/cytarabine, Sutimlimab, Authorization, Positive, SFL, Latanoprost, Obiltoxaximab, Mitapivat, European Medicines Agency, Janssen COVID-19 vaccine, Potassium, Ertapenem, Etranacogene dezaparvovec, Request, MVA, Brexucabtagene autoleucel, Ebola, Imipenem/cilastatin/relebactam, Relugolix/estradiol/norethisterone acetate, CHMP, Pfizer–BioNTech COVID-19 vaccine, Pitolisant, Naloxone, Bupivacaine, Atidarsagene autotemcel, Defibrotide, Rilpivirine, Moderna COVID-19 vaccine, Filo, Pertuzumab, Tafasitamab, Trastuzumab, AstraZeneca, Potassium citrate, COVID-19, INN, JCOVDEN, N/A, Alfa, Assessment, Setmelanotide, Casirivimab/imdevimab, Fair

18 April 2024

Key Points: 
    • 18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Article 63(1) request (orphan
      products)2

      Outcome 63(1)
      orphan products2

      Article 63(3) request for omission of
      certain particulars

      Outcome 63(3) omission of
      certain particulars

      Outcome date

      Product information

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive (partial)

      07/Mar/24

      Upstaza (eladocagene exuparvovec) - N/A
      Product information

      Authorised

      EMEA/H/C/005269/X/0033

      Kaftrio

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Positive (partial)

      21/Nov/23

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information
      Rezzayo (rezafungin) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005900

      Rezzayo

      Omission of particulars (immediate labelling)

      Positive

      30/Aug/23

      Authorised

      EMEA/H/C/005933

      Catiolanze

      Omission of particulars (immediate labelling)

      Positive

      13/Jul/23

      Catiolanze (latanoprost) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005756

      Apretude

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Jul/23

      Apretude, (cabotegravir) - Product
      information

      Apretude (cabotegravir) Assessment report

      Authorised

      EMEA/H/C/005985

      Tepkinly

      Positive (partial)

      14/Jun/23

      Tepkinly (epcoritamab) - Product
      information

      Tepkinly (epcoritamab) Assessment report

      Authorised

      EMEA/H/C/005849/X/0003

      Vyvgart

      Positive

      10/Mar/23

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005122

      Omvoh

      Omission of particulars (immediate labelling)

      Positive

      04/Jan/23

      Omvoh (mirikizumab) - Product
      information

      Omvoh (mirikizumab) Assessment report

      Authorised

      EMEA/H/C/004258

      Alofisel

      Omission of particulars (outer labelling)

      Positive (temporary)

      17/Nov/22

      Alofisel (darvadstrocel) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      N/A

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005484

      Loargys

      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Loargys (pegzilarginase) - Product
      information

      Authorised

      Authorised

      EMEA/H/C/005703

      Pombiliti

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Pombiliti (cipaglucosidase alfa) Product information

      Pombiliti (cipaglucosidase alfa) Assessment report

      Authorised

      EMEA/H/C/005695

      Opfolda

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Opfolda (miglustat) - Product
      information

      N/A

      Authorised

      EMEA/H/C/006016

      Imjudo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      IMJUDO - Product information

      Imjudo - Assessment report

      Authorised

      EMEA/H/C/004650

      Tremelimumab
      AstraZeneca

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Tremelimumab AstraZeneca Product information

      Tremelimumab AstraZeneca Assessment report

      Authorised

      EMEA/H/C/005776

      Enjaymo

      13/Sep/22

      Enjaymo (Sutimlimab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Authorised

      EMEA/H/C/004827

      Hemgenix

      Authorised

      EMEA/H/C/005751

      Columvi

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Article 63(3) request for translation
      exemption

      Positive (partial)

      13/Oct/22

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Outcome 63(3) request for
      translation exemption

      Positive (partial)

      Positive

      Assessment report

      N/A

      N/A

      N/A

      N/A

      Loargys (pegzilarginase) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      08/Aug/22

      Filsuvez (birch bark extract) Product information

      N/A

      Omission of particulars (outer labelling)

      Negative

      14/Jun/22

      Hemgenix - Product information

      Hemgenix - Assessment report

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Columvi, INN-glofitamab
      (europa.eu)

      N/A

      Authorised

      EMEA/H/C/005848

      Pemetrexed Baxter

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Pemetrexed Baxter - Product
      information

      Pemetrexed Baxter - Assessment
      report

      Authorised

      EMEA/H/C/005246/X/0002

      Byfavo

      Omission of particulars (immediate labelling)

      Negative

      14/Jun/22

      Byfavo - Product information

      N/A

      Authorised

      EMEA/H/C/005815

      Ertapenem SUN

      Omission of particulars (immediate labelling)

      Positive

      11/May/22

      Ertapenem SUN (ertapenem) Product information

      Ertapenem SUN (ertapenem) Assessment report

      Authorised

      EMEA/H/C/004850

      Xenpozyme

      12/Apr/22

      Xenpozyme (olipudase alfa) Product information

      Xenpozyme (olipudase alfa) Assessment report

      Authorised

      EMEA/H/C/005769

      Herwenda

      10/Mar/22

      Herwenda (trastuzumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005540

      Pyrukynd

      10/Mar/22

      Pyrukynd - Product information

      N/A

      Authorised

      EMEA/H/C/005680

      Lunsumio

      10/Mar/22

      Lunsumio (mosunetuzumab) Product information

      N/A

      Authorised

      EMA/H/C/004577

      Ebvallo

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      10/Mar/22

      Ebvallo - Product information

      Ebvallo - Assessment report

      Authorised

      EMEA/H/C/004929

      Kimmtrak

      Translation exemption (outer and
      immediate labelling)

      Positive

      16/Nov/21

      Kimmtrak (tebentafusp) - Product
      information

      Kimmtrak (tebentafusp) Assessment report

      Authorised

      EMEA/H/C/005378

      Nulibry

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      16/Nov/21

      Nulibry - Product information

      N/A

      Authorised

      EMEA/H/C/005849

      Vyvgart

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      16/Nov/21

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005973

      Paxlovid

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      16/Nov/21

      Paxlovid (nirmatrelvir + ritonavir) Product information

      Authorised

      EMEA/H/C/005788

      Evusheld

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      13/Oct/21

      Evusheld (ixagevimab, cilgavimab) - N/A
      Product information

      Authorised

      EMEA/H/C/005553

      Aspaveli

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/21

      Aspaveli (pegcetacoplan) - Product
      information

      Aspaveli (pegcetacoplan) Assessment report

      Authorised

      EMEA/H/C/005814

      Ronapreve

      Omission of particulars (immediate labelling)

      Positive

      24/Sep/21

      Ronapreve (casirivimab and
      imdevimab) - Produt information

      Ronapreve (casirivimab and
      imdevimab) - Assessment report

      Authorised

      EMEA/H/C/005550

      Artesunate Amivas

      14/Sep/21

      Artesunate Amivas (artesunate) Product information

      Artesunate Amivas (Artesunate) Assessment report

      Authorised

      EMEA/H/C/005854

      Regkirona

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Regkirona (regdanvimab) - Product
      information

      Regkirona (regdanvimab) Assessment report

      Authorised

      EMEA/H/C/005676

      Xevudy

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Xevudy (sotrovimab) - Product
      information

      Xevudy (sotrovimab) Assessment report

      Authorised

      EMEA/H/C/005182

      Trodelvy

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Trodelvy (sacituzumab govitecan) Product information

      Trodelvy (sacituzumab govitecan)
      - Assessment report

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Filsuvez (birch bark extract) Product information

      N/A

      Authorised

      EMEA/H/C/005095

      Carvykti

      Translation exemption (outer and
      immediate labelling)

      Positive

      17/Jun/21

      Carvykti (Ciltacaptagene autoleucel) - Carvykti (ciltacabtagene
      Product information
      autoleucel) - Assessment report

      Authorised

      EMEA/H/C/005467

      Voraxaze

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Voraxaze (glucarpidase) - Product
      information

      Authorised

      EMEA/H/C/005501

      Nexviadyme

      Omission of particulars (immediate labelling)

      17/Jun/21

      Nexviadyme (avalglucosidase alfa) - Nexviadyme (avalglucosidase
      Product information
      alfa) - Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      03/Jun/21

      Abecma (idecabtagene vicleucel) Product information

      Abecma (idecabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004275/II/0021

      Crysvita

      Positive

      06/May/21

      Crysvita (burosumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005475

      Voxzogo

      Positive (partial)

      04/Mar/21

      Voxzogo (vosoritide) - Product
      information

      Voxzogo (vosoritide) - CHMP
      assessment report

      Authorised

      EMEA/H/C/005737

      Jcovden

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Positive

      01/Mar/21

      Authorised

      EMEA/H/C/005327

      Abevmy

      Omission of particulars (immediate labelling)

      Positive

      JCOVDEN [COVID-19 vaccine
      (Ad26.COV2-S [recombinant]) Product information
      Abevmy (bevacizumab) - Product
      information

      JCOVDEN [COVID-19 Vaccine
      Janssen (Ad26.COV2-S,
      recombinant)] - Assessment
      Abevmy (bevacizumab) Assessment report

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      Omission of particulars (immediate labelling)

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive

      Omission of particulars (immediate labelling)

      Positive (partial)

      Translation exemption (outer labelling)

      Positive

      Positive (partial)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      13/Jan/21

      Paxlovid (nimatrelvir + ritonavir) Assessment report

      Voraxaze (glucarpidase) Assessment report

      Authorised

      EMEA/H/C/005791

      Spikevax

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      01/Jan/21

      Spikevax - Product information

      Spikevax - Assessment report

      Authorised

      EMEA/H/C/005735

      Comirnaty

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer and immediate
      labelling)

      Positive

      17/Dec/20

      Comirnaty (tozinameran,
      tozinameran/riltozinameran,
      tozinameran/famtozinameran) Alymsys (bevacizumab) - Product
      information

      Comirnaty (tozinameran,
      tozinameran/riltozinamearn,
      tozinamearn/famtozinameran) N/A

      Authorised

      EMEA/H/C/005286

      Alymsis

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Authorised

      EMEA/H/C/005556

      Oyavas

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Oyavas (bevacizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005145

      Evrysdi

      Omission of particulars (immediate labelling)

      Negative

      20/Oct/20

      Evrysdy (risdiplam) - Product
      information

      Evrysdi (risdiplam) - Assessment
      report

      Authorised

      EMEA/H/C/005089

      Imcivree

      20/Oct/20

      Imcivree (setmelanotide) - Product
      information

      Imcivree (setmelanotide) Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Abecma (idecabtagene vicleucel) Product information

      Abecma (decabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004731

      Breyanzi

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Breyanzi (lisocabtagene maraleucel) - N/A
      Product information

      Authorised

      EMEA/H/C/005386

      Phesgo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/20

      EMEA/H/C/005102

      Tecartus

      Omission of particulars (immediate labelling)

      Positive

      05/Oct/20

      Authorised

      EMEA/H/C/005675

      Vaxzevria

      Omission of particulars (outer and immediate Positive
      labelling)

      Phesgo (pertuzumab/trastuzumab) - Phesgo (pertuzumab /
      Product information
      trastuzumab) - Assessment
      report
      Tecartus (autologous anti-CD19Tecartus (autologous anti-CD19transduced CD3+ cells) - Product
      transduced CD3+ cells) information
      Assessment report
      Vaxzevria - Product information
      Vaxzevria - Assessment report

      Authorised

      Authorised

      EMEA/H/C/005246

      Byfavo

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Byfavo (remimazolam) - Product
      information

      Byfavo (remimazolam) Assessment report

      Authorised

      EMEA/H/C/004586

      Exparel liposomal

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Exparel liposomal (bupivacaine) Product information

      Exparel liposomal (bupivacaine) Assessment report

      Authorised

      EMEA/H/C/004954/X/0004/G

      Ultomiris

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Ultomiris (ravulizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004976

      Vocabria

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Vocabria (cabotegravir) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005060

      Rekambys

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Rekambys (rilpivirine) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005436

      Minjuvi

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Minjuvi (tafasitamab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/004379

      Amglidia

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Negative

      16/Jun/20

      Amglidia (glibenclamide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005271

      Zokinvy

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      16/Jun/20

      Zokinvy (lonafarnib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002393

      Defitelio

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      16/Jun/20

      Defitelio (defibrotide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005622

      Veklury

      15/May/20

      Veklury (remdesivir) - Product
      information

      Veklury (remdesivir) Assessment report

      Authorised

      EMEA/H/C/005269

      Kaftrio

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      22/May/20

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information

      N/A

      Authorised

      EMEA/H/C/005167

      Dovprela

      Translation exemption (outer and
      immediate labelling)

      Positive

      27/Mar/20

      Dovprela (pretomanid) - Product
      information

      Dovprela (pretomanid) Assessment report

      Authorised

      EMEA/H/C/004077/X/0032

      Darzalex

      20/Mar/20

      Darzalex (daratumumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002614

      Sirturo

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Sirturo (bedaquiline) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005321

      Libmeldy

      Translation exemption (outer,
      intermediate, immediate labelling
      and lot information sheet)

      Positive

      03/Mar/20

      Libmeldy (atidarsagene autotemcel) - Libmeldy (atidarsagene
      Product information
      autotemcel) - Assessment report

      Authorised

      EMEA/H/C/004849

      Idefirix

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Idefirix (imlifidase) - Product
      information

      Idefirix (imlifidase) - Assessment
      report

      Authorised

      EMEA/H/C/000829/X/0122/G

      Pradaxa

      03/Mar/20

      Pradaxa (dabigatran etexilate) Product information

      Pradaxa (dabigatran etexilate) Assessment report

      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Positive

      Positive

      Positive

      Positive

      Translation exemption (outer and immediate
      labelling)

      Positive

      07/Jul/20

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004829

      Fetcroja

      Authorised

      EMEA/H/C/005169

      Obiltoxaximab SFL

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005205

      Zynrelef

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/003860/N/0027

      Nucala

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Nucala (mepolizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004808

      Recarbrio

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/004750

      Zolgensma

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Recarbrio
      (imipenem/cilastatin/relebactam) Product information
      Zolgensma (Onasemnogene
      abeparvovec) - Product information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      26/Mar/19

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Recarbrio
      (imipenem/cilastatin/relebactam) Assessment report
      Zolgensma (Onasemnogene
      abeparvovec) - Assessment
      report
      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Authorised

      EMEA/H/C/004282

      Vyxeos liposomal

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      09/Oct/18

      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Vyxeos liposomal
      N/A
      (daunorubicin/cytarabine) - Product
      information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      09/Oct/18

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/004275

      Crysvita

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      Oct/17

      Crysvita (burosumab) - Product
      information

      Crysvita (busorumab) Assessment report

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Mar/20

      Coagadex (human coagulation factor N/A
      X) - Product information

      03/Mar/20

      Upstaza (eladocagene exuparvovec) - Upstaza (eladocagene
      Product information
      exuparvovec) - Assessment
      report
      Coagadex (human coagulation factor N/A
      X) - Product information

      13/Jan/20

      Omission of particulars (immediate labelling)

      19/Nov/19

      Fetcroja (cefiderocol) - Product
      information

      Positive (partial)

      08/Oct/19

      Positive (partial)

      08/Oct/19

      Obiltoxaximab SFL (obiltoxaximab) - Obiltoxaximab SFL
      Product information
      (obiltoxaximab) - Assessment
      report
      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Zynrelef (bupivacaine/meloxicam) - Zynrelef (bupivacaine/meloxicam)
      Product information
      - Assessment report

      Omission of particulars (immediate labelling)

      Omission of particulars (outer labelling)

      Positive

      Negative

      Positive

      Fetcroja (cefiderocol) Assessment report

      18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requested with the aim to create multilingual packages and examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Request for omission of particulars

      Outcome request for Request for translation exemption
      omission of
      particulars

      Authorised

      EMEA/H/C/005107/N/0022

      Roclanda

      Omission of particulars (immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004452/X/0028

      Erleada

      Omission of particulars (immediate labelling)

      Authorised

      EMEA/H/C/000697

      Suboxone

      Authorised

      EMEA/H/C/005843

      Authorised

      Product information

      Assessment report

      21/Nov/23

      Roclanda (netarsudil
      mesylate/latanoprost) - Product
      information

      N/A

      Positive

      10/Mar/23

      Erleada, INN - apalutamide
      (europa.eu)

      Erleada (apalutamide) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Suboxone (naloxone) - Product
      information

      N/A

      Opzelura

      Omission of particulars (immediate labelling)

      Positive (partial)

      13/Oct/22

      Opzelura (ruxolitinib) - Product
      information

      Opzelura (Ruxolitinib ) Assessment report

      EMEA/H/C/005361

      Akeega

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Akeega (niraparib/abiraterone
      acetate) - Product information

      N/A

      Authorised

      EMEA/H/C/002465/X/0035

      Procysbi

      Omission of particulars (immediate labelling)

      Positive

      16/Nov/21

      Procysbi (mercaptamine
      bitartrate) - Product information

      N/A

      Authorised

      EMEA/H/C/005367

      Skytrofa

      Omission of particulars (immediate labelling)

      Positive (partial)

      17/Jun/21

      Skytrofa (lonapegsomatropin) Product information

      Skytrofa (lonapegsomatropin) Assessment report

      Authorised

      EMEA/H/C/000610/X/0063

      Noxafil

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Noxafil (posaconazole) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005267

      Ryeqo

      Omission of particulars (immediate labelling)

      Positive

      04/Mar/21

      Ryeqo
      N/A
      (Relugolix/Estradiol/Norethistero
      ne acetate) - Product information

      Authorised

      EMEA/H/C/005117

      Ozawade

      Omission of particulars (outer and immediate labelling)

      Positive

      04/Mar/21

      Ozawade (Pitolisant) - Product
      information

      Ozawade (Pitolisant) Assessment report

      Authorised

      EMEA/H/C/005208

      Ayvakyt

      Omission of particulars (immediate labelling)

      Negative

      20/Jun/20

      AYVAKYT (avapritinib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004835

      Zeposia

      Omission of particulars (immediate labelling)

      Positive (partial)

      08/Oct/19

      Zeposia (ozanimod) - Product
      information

      Zeposia (ozanimod) - Public
      assessment report

      Authorised

      EMEA/H/C/005243

      Lacosamide UCB

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Lacosamide UCB (lacosamide) Product information

      N/A

      Authorised

      EMEA/H/C/004452

      Erleada

      Omission of particulars (immediate labelling)

      Positive

      09/Oct/18

      Erleada (apalutamide) - Product
      information

      Erleada (apalutamide) - Public
      assessment report

      Translation exemption (immediate labelling)

      Outcome translation Outcome date
      exemption

      Positive

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

Retrieved on: 
torsdag, april 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

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

      Page 4/30

      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

      Page 7/30

      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

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

      Page 15/30

      Table 4.2.2.

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

      Page 16/30

      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

      Page 17/30

      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.

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

      Page 21/30

      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
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

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

      Page 23/30

      728

      5.2.2.2.

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

      Page 24/30

      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

      Page 27/30

      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 the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
torsdag, april 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

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

      Page 4/30

      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

      Page 7/30

      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

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

      Page 15/30

      Table 4.2.2.

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

      Page 16/30

      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

      Page 17/30

      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.

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

      Page 21/30

      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
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

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

      Page 23/30

      728

      5.2.2.2.

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

      Page 24/30

      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

      Page 27/30

      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

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on: 
söndag, mars 10, 2024
Capsule, HPRA, EXP, NAAM, Pi, CS, ATMP, Table, Unicode, Health education, Potassium iodide, Syringe, VIAL, Inn, Potassium, NRG, Powder, Translation, Blister, Patient, Guideline, Abbreviation, SIDC, WHO, COPD, ISO, Compilation, Diabetes, DA, Prohibition, Times New Roman, Excipient, Narcotic, FAQ, Approximation error, Sodium chloride, PI, Cmax, Microsoft Word, NOT, Veterinary medicine, European Medicines Agency, Council, PFU, QRD, Helicobacter pylori, Tablet, Microsoft, Total, Medication package insert, European, DIE, Language, Single Supervisory Mechanism, Plaque, Vaccine, MAH, Safety, Printing, International standard, Sodium, Osteoporosis, Reproduction, Name, Marketing authorisation, Marketing, Caregiver, Imperial, NCA, Food, EDQM, Confusion, Risk, Cell, Medicine, Disease, Public, Medical device

29 February 2024

Key Points: 
    • 29 February 2024
      EMA/25090/2002 rev.23*
      Human Medicines Division

      Compilation of QRD decisions on stylistic matters in product information
      Issues
      Abbreviations

      Connected problems
      Subscript and superscript

      QRD Suggestions
      Acronyms must be written in their standard form; e.g.

    • Cmax, Cmax
      Abbreviations and

      Not always understood,

      Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.

    • The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
      i.e.
    • critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 2/23

      Issues

      Connected problems

      QRD Suggestions

      emphasise in the labelling
      the special handling prior
      to administration of the
      product.

    • Consistency

      Inconsistencies in style are

      Once a particular style or house style has been selected, it must be used consistently throughout the text.

    • Tradename 150 mg solution for injection in pre-filled syringe
      Tradename 150 mg solution for injection in pre-filled pen

      information annexes?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 3/23

      Issues
      Desiccant

      Connected problems

      QRD Suggestions

      For medicinal products

      The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

      packaged with a desiccant

      the desiccant.

    • For bottles containing a desiccant, a similar statement should also be considered provided there

      mistake the desiccant for a

      is available space.

    • It can only be included in brackets in section 3 of the

      where can this be

      SmPC and section 4 of the labelling.

    • Direct speech should only
      be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
    • The term ?drug? though can be used in the product information annexes when it is part of a standard set of
      terms (e.g.
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 5/23

      Issues
      Foreign terms

      Connected problems

      QRD Suggestions

      Foreign terms, particularly

      Foreign terms must be written in italics; e.g.

    • Patients can be referred to as ?he? or

      physician is often referred

      as ?she? when the medicinal product is exclusively for use by males or females.

    • if the product in question might be

      measurements are

      used by elderly patients), in brackets after the metric measures in the English text.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 6/23

      Issues

      Connected problems

      QRD Suggestions

      product name is composed
      of MAH+INN?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 7/23

      Issues

      Connected problems

      QRD Suggestions
      MT: English
      BG: Bulgarian
      NL: Dutch
      CZ: Czech or English at applicant?s discretion.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 14/23

      Issues

      Connected problems

      QRD Suggestions
      considered, e.g.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 16/23

      Issues
      Symbols: Non-Unicode

      Connected problems

      QRD Suggestions

      The use of non-Unicode

      Only Unicode symbols must be used in submitted product information annexes.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 20/23

      Issues

      Connected problems

      Units: SI base units -

      International Standard

      litre

      base units have been
      introduced in the European
      Union with Council
      Directive 80/181/EEC of
      20.12.79 (O.J.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 23/23

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Retrieved on: 
lördag, februari 17, 2024
Penta, Committee, Infection, Leukopenia, Lotilaner, Atopic dermatitis, Cattle, Dog, Sheep, CVMP, InterDigital, Skin, Viral, Hyperthermia, Metritis, Chicken, Horse, Viremia, Classification, Drinking water, Cat, QRD, Guideline, The Committee

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

Key Points: 
  • The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
  • The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
  • Concept papers, guidelines
    Quality
    The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
  • The comments received during the consultation procedure were taken into account for the revision of the annex.

Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive

Retrieved on: 
lördag, december 30, 2023
Marketing, European Commission, Afoxolaner, Ixodes, Civil service commission, Dog, QRD, UPD, Flea, European Medicines Agency, CVMP, Breeding, Intention, Tablet, Committee, Female, SPC

On 5-7 December 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Frontpro.

Key Points: 
  • On 5-7 December 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Frontpro.
  • The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
  • Frontpro is currently authorised as chewable tablets for the treatment of flea and tick infestations in dogs.
  • 1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion

Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive

Retrieved on: 
måndag, december 18, 2023
Flea, Ixodes, SPC, European Medicines Agency, European Commission, UPD, Tablet, Afoxolaner, QRD, Civil service commission, Marketing, Committee, Breeding, Intention, CVMP, Female, Dog

On 5-7 December 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Frontpro.

Key Points: 
  • On 5-7 December 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Frontpro.
  • The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
  • Frontpro is currently authorised as chewable tablets for the treatment of flea and tick infestations in dogs.
  • 1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 2023

Retrieved on: 
måndag, december 18, 2023
Ixodes, European Commission, Decision-making, GMP, SPC, Sheep, The Committee, UPD, MRP, QRD, EMA, Civil service commission, Q&A, DCP, Committee, Product, Science, MAH, Breeding, QR, CVMP, Review, Female, Guideline, CP, Dog, Cattle, Classification, Risk management, Automotive industry, Vaccine, Medical device, Real estate, Regulation, Frunevetmab

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management…

Key Points: 


The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management…

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 19 September 2023

Retrieved on: 
måndag, december 18, 2023
ACT, ETF, HCP, ICH, Location, MSP, Social media, QRD, Group, EMA, PCWP, Patient, Communication, Consumer, Health professional, Health care, Nursing, Birth control

Date

Key Points: 
  • Date
    - Tuesday, 19 September 2023
    Location
    - OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
    The Patients and Consumers' Working Party (PCWP) and the Healthcare Professionals' Working Party (HCPWP) will hold their joint plenary meeting on 19-20 September 2023.
  • During the second half-day, the working parties will discuss clinical trials and EMA communications, with updates from recent international activities.
  • Emergency Task Force (ETF)
    1.2 HМА/EMA Joint Big Data Steering Group (BDSG)
    1.3.
  • ICH E21 Concept paper on inclusion of pregnant and breastfeeding individuals in clinical trials
    6.2: ACT EU Multi-stakeholder platform (MSP) advisory group update
    7.1.