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511332.6 cooperation with competent authoritiesreferrals and arbitrationsthere were 9 referral procedures in 2000, of which 5 were finalised.information on finalised procedures are published on the emea web site.type of referralarticle 7(5) commission regulation ec 541/95 article 10 council directive 75/319/eec article 11 council directive 75/319/eec article 12, council directive 75/319/eec article 15, council directive 75/319/eecdate of cpmp final opinion 27.07.2000 procedure ongoing 29.06.2000 procedure ongoing 19.10.2000 16.11.2000 procedure ongoing procedure ongoing 19.10.2000international non-proprietary name (inn)zofenopril cerazette ketoprofen retard scand pharm capthydro glucophagesibutramin calcitonins cisapride sertindoleinternational conference on harmonisationinternational conference on harmonisation (ich)final guidelines· choice of control group in clinical trials (cpmp/ich/364/96) ,ich e10· clinical investigation of medicinal products in children (cpmp/ich/2711/99) ,ich e11· safety pharmacology studies for human pharmaceuticals (cpmp/ich/539/00) ,ich s7a· stability testing guidelines: stability testing of new active substances and medicinalproducts (cpmp/ich/2736/99 rev. of cpmp/ich/380/95) , ich q1ar· non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals(cpmp/ich/286/95, modification) , ich m3 modification· reproductive toxicology: toxicity to male fertility (cpmp/ich/136/95 modification) ,ich s5b modification· data elements for transmission of individual case safety reports (cpmp/ich/287/95modification) , ich e2b· recommendations on electronic transmission of individual case safety reports messagespecification (cpmp/ich/285/95) , ich m2· good manufacturing practice guide for active pharmaceutical ingredients(cpmp/ich/4106/00) , ich q7a· common technical document (ctd) , (cpmp/ich/2887/99) , ich m434 emea general report 2000guidelines released for consultation· bracketing and matrixing designs for stability testing of drug substances and drugproducts (cpmp/ich/4104/00) , ich q1d· maintenance of the guideline on impurities: residual solvents: permissible daily exposure(pde) for tetrahydrofuran and n. methylpyrrolidine (cpmp/ich/283/95) , ich q3c(m)details of these and other cvmp guidelines are given in annex 11.working party on herbal medicinal productsthe working party on herbal medicinal products met at the emea on 3 occasions in 2000, chaired by konstantin keller.the working party was involved in the review of the risks associated with the use of herbal medicinal products containing aristolochia.a position paper was prepared in collaboration with cpmp pharmacovigilance and safety working parties and published in november 2000.details of notes for guidance and position papers from the group are given in annex 11.a meeting with european interested associations was held in october 2000.topics discussed included the scope of dialogue and proposals for improved transparency in the communication from the working party to the public on herbal related matters.2.7 activities of the mutual recognition facilitation groupthe mutual recognition facilitation group (mrfg) is intended to coordinate and facilitate the operation of the mutual recognition procedure.the 11 meetings of the group were chaired by antónio melo gouveia during the portuguese presidency in the first half of 2000 and jean-michel alexandre during the french presidency in the second half.two informal meetings of the mrfg were organised under the presidencies to discuss issues related to the mutual recognition procedure such as transparency, quality of assessments and the 2001 review were discussed.
comp on euroopan unionin ensimmäinen toimielinkomitea, jossa on potilaisjärjestöjen edustajia täysivaltaisina jäseninä.puheenjohtajaksi valittiin josep torrent i farnell ja varapuheenjohtajaksi yann le cam, kumpikin kolmivuotiskaudeksi, joka on mahdollista uusia kerran.harvinaislääkkeeksi määrittelemistä koskevat hakemukset ensimmäiset harvinaislääkkeeksi määrittelemistä koskevat hakemukset jätettiin emealle huhtikuussa 2000.emea piti 25 hakemuksen jättämistä edeltävää kokousta rahoittajien avustamiseksi.ilmaistu jätetyt peruutetut comp: n comp: n komission vuosi aikomus hakemukset hakemukset myönteiset kielteiset myöntämät hakemuksen lausunnot lausunnot harvinaislääke jättämiseen -määritelmät 2000 29 71 3 26 --8kutakin hakemusta varten nimitetään koordinaattori emeasta ja comp: stä.heitä avustavat harvinaisten sairauksien asiantuntijat, jotka valitaan komitean nimeämästä luettelosta.vuoden 2000 lopussa luettelossa oli 66 asiantuntijaa.emea/mb/050 vuosikertomus 2000 sivu 28/85 vuonna 2000 eniten harvinaislääkkeeksi määrittelemistä koskevia hakemuksia tuli syöpälääkkeiden ja syövän biologisen hoidon (luokka l) hoitoluokkaan.