Medic­i­nal prod­ucts

• Clin­i­cal tri­als
  • Clin­i­cal Tri­als In­for­ma­tion Sys­tem - CTIS
  • Com­pas­sion­ate Use
  • GCP In­spec­tions Unit
• Li­cens­ing
  • Types of Mar­ket­ing Au­tho­ri­sa­tion
    • Li­cens­ing of Biosim­i­lars
    • In­ter­change­abil­i­ty of biosim­i­lars
    • Bib­li­o­graph­i­cal Ap­pli­ca­tion
    • Com­ple­men­tary and Al­ter­na­tive Medicines (CAM) and Tra­di­tion­al Medic­i­nal Prod­ucts (TMP)
  • Li­cens­ing Pro­ce­dures
    • Cen­tralised Pro­ce­dures
    • Na­tion­al Li­cens­ing Pro­ce­dures
    • De­cen­tralised Pro­ce­dure (DCP) - Mu­tu­al Recog­ni­tion Pro­ce­dure (MRP)
    • Par­al­lel im­port of medic­i­nal prod­ucts
  • Fol­low-up Pro­ce­dures
    • Re­newals
    • Writ­ten re­nounce­ment
    • Vari­a­tions
      • Vari­a­tions
      • Na­tion­al Vari­a­tions
    • Sun­set Clause
    • Pub­li­ca­tion of clin­i­cal tri­als re­sults acc. Sec­tion 42b AMG
  • Is­sues Rel­e­vant for Li­cens­ing
    • In­for­ma­tion on WHO Cer­tifi­cates
    • eS­ub­mis­sion
    • Brex­it
    • Phar­ma­copoeia
      • Phar­ma­copoeia Com­mis­sions
    • De­mar­ca­tion/Bor­der­line ques­tions
      • Joint Com­mis­sion of Ex­perts on the Clas­si­fi­ca­tion of Sub­stances
  • Medicines for chil­dren
    • EU-reg­u­la­tion on medic­i­nal prod­ucts for chil­dren
    • Pae­di­atric Work­shar­ing
  • Medicines for rare dis­eases
• GCP In­spec­tions Unit
• Phar­ma­covig­i­lance
  • Re­port­ing risks
  • Risk in­for­ma­tion
    • Rote-Hand-Briefe and In­for­ma­tion Let­ters
    • Oth­er risk in­for­ma­tion
    • Risk As­sess­ment Pro­ce­dures
    • List of medicines un­der ad­di­tion­al mon­i­tor­ing
    • Ed­u­ca­tion­al ma­te­ri­al
    • Eu­ro­pean Database on Ad­verse Drug Re­ac­tion Re­ports
    • Risk Man­age­ment Plans (RMP)
    • Risk in­for­ma­tion on medic­i­nal prod­ucts
  • Pe­ri­od­ic Safe­ty Up­date Re­ports (PSURs)
    • PSUR Repos­i­to­ry
  • Grad­u­at­ed plan of­fi­cer
  • Boards and Com­mit­tees
    • Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee (PRAC)
    • Pre­scrip­tion-on­ly is­sues
    • Phar­ma­cy-on­ly is­sues
    • Rou­tine ses­sions
• Medic­i­nal prod­ucts in­for­ma­tion
  • Rapid Alert Sys­tem
  • Sup­ply short­ages
    • Ad­vi­so­ry Board on short­ages
    • AL­BVVG
    • Joint Ac­tion CHESS­MEN
    • Mit­i­ga­tion mea­sures
    • Re­port­ing obli­ga­tions
    • SPOC on short­ages
    • ICU Task­force
  • Fal­si­fied Medicines Di­rec­tive
  • Ref­er­ence Pric­ing
  • On­line medicine re­tail­ers
    • EU Se­cu­ri­ty Lo­go
    • Reg­is­tered On­line Medicine Re­tail­ers
  • Re­search medic­i­nal prod­ucts
    • Prices and Con­di­tions
    • Medic­i­nal Prod­uct In­for­ma­tion Sys­tem AM­Ice
      • Database de­scrip­tion for AM­Ice Batch Re­lease
      • Database de­scrip­tion for AM­Ice Sub­stances
      • Database de­scrip­tion for AM­Ice Terms of Sub­stances
      • Database de­scrip­tion for AM­Ice Medic­i­nal Prod­ucts
  • Pharm­Net.Bund

Med­i­cal de­vices

• Reg­u­la­to­ry frame­work
  • Ba­sic in­for­ma­tion
    • Con­for­mi­ty as­sess­ment
  • Laws and reg­u­la­tions
  • In­sti­tu­tions
    • Com­pe­tent Au­thor­i­ties
    • Ethics Com­mit­tees
    • No­ti­fied Bod­ies
  • Eu­rope and EU­DAMED
• Tasks of the BfArM
  • Clin­i­cal in­ves­ti­ga­tions and per­for­mance stud­ies
    • Clin­i­cal in­ves­ti­ga­tions ac­cord­ing to MDR / MPDG
      • Re­quest for au­tho­ri­sa­tion
      • No­ti­fi­ca­tion of a Post-Mar­ket Clin­i­cal Fol­low-up in­ves­ti­ga­tion
      • No­ti­fi­ca­tion of oth­er clin­i­cal in­ves­ti­ga­tions
      • Sub­stan­tial mod­i­fi­ca­tions
      • Halt, Ter­mi­na­tion or End of a Clin­i­cal In­ves­ti­ga­tion
    • Per­for­mance stud­ies of in vit­ro di­ag­nos­tic med­i­cal de­vices
      • Halt, Ter­mi­na­tion or End of a Per­for­mance Study
      • Re­quest for waiv­ing the au­tho­ri­sa­tion
      • Au­tho­ri­sa­tion
      • No­ti­fi­ca­tion of a Post-Mar­ket Per­for­mance Study
      • Sub­stan­tial mod­i­fi­ca­tions
      • No­ti­fi­ca­tions of per­for­mance stud­ies with CDx left-over sam­ples
    • Ap­pli­ca­tion for de­ci­sion on re­quire­ment to ap­prove MD / IVD
  • Risk as­sess­ment
    • Re­port­ing risks
    • Field cor­rec­tive ac­tions
    • BfArM rec­om­men­da­tions
  • Dif­fer­en­ti­a­tion and clas­si­fi­ca­tion
  • Di­GA and Di­PA
    • Dig­i­tal nurs­ing ap­pli­ca­tions (Di­PA)
      • In­ter­est­ing facts
    • Dig­i­tal Health Ap­pli­ca­tions (Di­GA)
      • In­ter­est­ing facts
  • DMIDS
    • Clin­i­cal in­ves­ti­ga­tions and per­for­mance stud­ies
    • No­ti­fi­ca­tion of Med­i­cal De­vices and In vit­ro Di­ag­nos­tics
    • Pub­lic databas­es
      • Database In­for­ma­tion Med­i­cal De­vices No­ti­fi­ca­tion
      • Database In­for­ma­tion In Vit­ro Di­ag­nos­tic Med­i­cal De­vices No­ti­fi­ca­tions
      • Database In­for­ma­tion Med­i­cal De­vices Ad­dress­es
    • Op­er­at­ing the sys­tem
      • Sys­tem re­quire­ments
  • Fur­ther tasks
    • Coro­na Pan­dem­ic
    • Com­pan­ion di­ag­nos­tics (CDx)
  • FAQ and con­tact per­sons
• Con­tact per­sons
• Re­ports and Cor­rec­tive Ac­tions
  • In­ci­dent re­port
  • SAE and DD re­port
    • SAE and DD re­port­ing for per­for­mance stud­ies
    • SAE and DD re­port­ing for clin­i­cal in­ves­ti­ga­tions
  • Re­call re­port
  • Overview re­port­ing chan­nels
  • Field cor­rec­tive ac­tions
• Por­tals
  • Di­GA- and Di­PA-Por­tal
  • DMIDS

Code sys­tems

• Clas­si­fi­ca­tions
  • ICD
    • ICD-10-GM
      • Al­pha­bet­i­cal in­dex
      • Ap­pli­ca­tion
      • Code-Search
      • His­to­ry and out­look
      • Pro­pos­al pro­ce­dure
      • Tab­u­lar list
      • Ver­sions and for­mats
    • ICD-11
    • ICD-10-WHO
      • Al­pha­bet­i­cal in­dex
      • Ap­pli­ca­tion
      • Caus­es of death statis­tics
      • Code-Search
      • His­to­ry and out­look
      • In­struc­tion man­u­al
      • Tab­u­lar list
    • ICD-O-3
      • Code-Search
  • OPS, ICHI
    • OPS
      • Al­pha­bet­i­cal in­dex
      • Ap­pli­ca­tion
      • Code-Search
      • His­to­ry and out­look
      • Pro­pos­al pro­ce­dure
      • Tab­u­lar list
      • Ver­sions and for­mats
    • ICHI
  • ATC
  • IVD ED­MA
  • ICF
• Ter­mi­nolo­gies
  • SNOMED CT
    • Ap­pli­ca­tion for a SNOMED CT af­fil­i­ate li­cence
    • Sub­mit change re­quests for SNOMED CT
    • Re­quest Ger­man trans­la­tions of SNOMED CT con­cepts
    • In­for­ma­tion about SNOMED CT
    • Work­ing Group AG SNOMED
    • Na­tion­al Re­lease Cen­ter (NRC)
    • Train­ing cours­es and events
    • Why SNOMED CT?
    • Na­tion­al Edi­tion / Na­tion­al Ex­ten­sion
  • LOINC
    • Change Re­quests
    • Ger­man trans­la­tions of LOINC terms
    • KKG AG LOINC
    • LOINC at BfArM
    • Fur­ther In­for­ma­tion
  • UCUM
  • Al­pha-ID-SE
    • Na­tion­al project rare dis­eases cod­ing
  • UMDNS, EMDN
    • UMDNS
• Col­lab­o­ra­tion and projects
  • KKG
  • WHO Col­lab­o­rat­ing Cen­tre
  • EU projects
    • RD-Code
    • RD-Ac­tion
  • Or­phanet
  • Iris In­sti­tute
    • Iris News
      • Iris News - sub­scribe and un­sub­scribe
    • Down­loads
    • Iris soft­ware
    • Iris users
    • Iris sup­port
    • Events and train­ings
    • Iris and ICD-11
  • Pi­lot of a na­tion­wide elec­tron­ic death cer­tifi­cate
  • Fur­ther col­lab­o­ra­tion
• Ser­vices
  • Down­loads
  • Ter­mi­nol­o­gy­serv­er
  • Code-Search on­line ver­sions
  • OID reg­istry
    • OID-Ap­pli­ca­tion
  • FAQ/Con­tact

Fed­er­al Opi­um Agen­cy

• Nar­cot­ic drugs
  • Li­cences
  • No­ti­fi­ca­tions
  • Records
  • Im­port and Ex­port
  • Trav­el­ling with nar­cot­ic drugs
• Pre­cur­sors
  • Im­port and Ex­port
  • Li­cence and Reg­is­tra­tion
  • An­nounce­ments
• T-pre­scrip­tions
• Sub­sti­tu­tion Reg­is­ter
• Con­tact per­sons

About us

• Or­gan­i­sa­tion
  • Head
  • Li­brary
• Tasks
  • Re­search
    • Bio­statis­tics
    • Spe­cial In­di­ca­tions
    • Re­search and Projects on Med­i­cal De­vice Safe­ty
    • Phar­ma­coge­nomics
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    • Neu­ropsy­chophar­ma­col­o­gy
    • Drug al­ler­gies
    • Pub­li­ca­tions
  • Ad­vice pro­ce­dures
    • Kick-off Meet­ing through the In­no­va­tion Of­fice at the BfArM
    • Sci­en­tif­ic Ad­vice and Pre-sub­mis­sion Meet­ing
    • Joint Ad­vice BfArM and G-BA
  • DRKS - Ger­man Clin­i­cal Tri­als Reg­is­ter
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    • Statis­tics
• Con­tact per­sons
• EU and In­ter­na­tion­al
  • CHMP
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  • Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee (PRAC)
  • EU Projects
    • EU4Health Pro­gramme
      • In­creaseNET
      • HDP4Ger­many
  • In­ter­na­tion­al Col­lab­o­ra­tions
    • GH­PP
      • Pharm­Train2
        • All re­ports
        • eLearn­ing
        • Guide­lines
        • Man­u­als
        • Ca­pac­i­ty De­vel­op­ment
        • Har­mon­i­sa­tion
        • Struc­ture De­vel­op­ment
        • Pub­li­ca­tions
      • Lab­Train
        • All re­ports
    • ICH - The In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use
  • GH­PP
    • Pharm­Train2
      • All re­ports
      • eLearn­ing
      • Guide­lines
      • Man­u­als
      • Ca­pac­i­ty De­vel­op­ment
      • Har­mon­i­sa­tion
      • Struc­ture De­vel­op­ment
      • Pub­li­ca­tions
    • Lab­Train
      • All re­ports

News

• News from the di­vi­sions
  • New in­for­ma­tion in the top­ic code sys­tems
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  • New in­for­ma­tion in the top­ic Phar­ma­covig­i­lance
  • New in­for­ma­tion in the top­ic clin­i­cal tri­als
  • New in­for­ma­tion in the top­ic medic­i­nal prod­ucts
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