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revised guideline:
revised guideline:
Last Update: 2011-10-23
Usage Frequency: 1
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guideline ecb / 2004/18
guideline ecb / 2004/18
Last Update: 2011-10-23
Usage Frequency: 1
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guideline on the format and content of annual reports
guideline on the format and content of annual reports
Last Update: 2011-10-23
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guideline for the photostability testing of new drug substances and products
guideline for the photostability testing of new drug substances and products
Last Update: 2011-10-23
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ecb guideline on the exchange of banknotes ( ecb / 2006/10 )
ecb guideline on the exchange of banknotes ( ecb / 2006/10 )
Last Update: 2011-10-23
Usage Frequency: 1
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guideline on responsibilities and enforcement measures in respect of verifying and ensuring gmp compliance
guideline on responsibilities and enforcement measures in respect of verifying and ensuring gmp compliance
Last Update: 2011-10-23
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asiakirjan nimi guideline on the format and content of applications for designation as orphan medicinal products
titel document guideline on the format and content of applications for designation as orphan medicinal products
Last Update: 2011-10-23
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guideline for competent authorities for the verification and evaluation of pharmacovigilance information for veterinary medicinal products
guideline for competent authorities for the verification and evaluation of pharmacovigilance information for veterinary medicinal products
Last Update: 2011-10-23
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asiakirjan nimi guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure
titel document guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure
Last Update: 2011-10-23
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päivitetty riskienhallintasuunnitelma tulee toimittaa ihmisille tarkoitetuille lääkevalmisteille laaditun chmp: n ohjeen guideline on risk management systems mukaisesti.
een bijgewerkt risicobeheerplan, volgens de chmp-richtlijnen voor risicobeheersystemen voor geneesmiddelen voor humaan gebruik, dient te worden ingediend.
Last Update: 2012-04-11
Usage Frequency: 2
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selvitys concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology- derived products
concept-rapporten concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products
Last Update: 2011-10-23
Usage Frequency: 1
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kuten chmp: n antamassa ohjeessa guideline on risk management for medicinal products for human use on kerrottu, päivitetty riskienhallintajärjestelmä on toimitettava samanaikaisesti seuraavan is
zoals staat vastgelegd in de chmp guideline on risk management systems for medicinal products for human use dient de meest recente versie van het rmp tegelijkertijd te worden ingediend met het volgende periodic safety update report (psur). es
Last Update: 2012-04-11
Usage Frequency: 2
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risk management plan päivitetty risk management plan on toimitettava siten kuin chmp: n anatamassa ohjeessa guideline on risk management systems for medicinal products for human use on sanottu.
een aangepast risk management plan dient te worden verschaft volgens de chmp richtlijn betreffende risk management systems voor geneesmiddelen voor humaan gebruik.
Last Update: 2012-04-11
Usage Frequency: 2
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neuvosto on päättänyt maatalousmenojen valvonnan, niin sanotunmenolinjauksen (”guideline”)periaatteista. maatalousmenojenlaskennan ja soveltamisen yksityiskohdat on määritelty budjettikuriakoskevassa neuvoston päätöksessä.
de europese raad heeft de beginselen van een richtsnoer(„guideline”)voor de beheersing van de landbouwuitgaven vastgesteld, waarvan deberekeningsmethode en de toepassing zijn uitgewerkt in de beschikkingvan de raad over de begrotingsdiscipline.
Last Update: 2014-02-06
Usage Frequency: 1
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prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)
prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)
Last Update: 2011-10-23
Usage Frequency: 1
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amendments to guideline ecb / 2000/7 on monetary policy instruments and procedures of the eurosystem ( ecb / 2009/1 )
amendments to guideline ecb / 2000/7 on monetary policy instruments and procedures of the eurosystem ( ecb / 2009/1 )
Last Update: 2011-10-23
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päivitetty riskinhallintasuunnitelma tulee toimittaa seuraavan määräaikaisen turvallisuuskatsauksen (psur) yhteydessä, ihmisille tarkoitetuille lääkevalmisteille laaditun chmp: n ohjeen guideline on risk management systems mukaisesti.
zoals beschreven in de chmp richtlijn over risk management systems voor geneesmiddelen voor gebruik bij mensen, dient de herziene versie van het rmp gelijktijdig ingediend te worden met het volgende periodieke veiligheidsrapport (psur).
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
kuten chmp: n antamassa ohjeessa guideline on risk management for medicinal products for human use on kerrottu, päivitetty riskienhallintajärjestelmä on toimitettava samanaikaisesti seuraavan turvallisuuskatsauksen (psur) kanssa.
34 zoals staat vastgelegd in de chmp guideline on risk management systems for medicinal products for human use dient de meest recente versie van het rmp tegelijkertijd te worden ingediend met het volgende periodic safety update report (psur).
Last Update: 2012-04-11
Usage Frequency: 3
Quality:
kuten chmp: n guideline´ssa koskien ihmisille tarkoitettujen lääkevalmisteiden risk management systemsíä, risk management plan tulee toimittaa samaan aikaan seuraavan periodic safety update reportín (psur) kanssa.
volgens de richtlijn van de chmp voor risk management systems voor geneesmiddelen voor humaan gebruik, dient een aangepast rmp te worden ingediend op hetzelfde tijdstip als het volgende periodieke veiligheidsverslag (psur).
Last Update: 2012-04-11
Usage Frequency: 4
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