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Proposal · PC

CELEX 52002PC0735

Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

Original

openEuropean Union· European Commission· EN

Introduced

10 December 2002

Last action

10 December 2002 · Published

Status

open

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Subjects

Discovery layer

Source updated

10 December 2002

Timeline

  1. 10 December 2002

    Published

    Source: work_date_document

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Documents

11 official files

  • Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

    preparatory · EN · 10 December 2002

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  • Propuesta modificada de Reglamento del Parlamento Europeo y del Consejo por el que se establecen procedimientos comunitarios para la autorización, la supervisión y la farmacovigilancia en lo relativo a los medicamentos de uso humano y veterinario y por el que se crea la Agencia Europea para la Evaluación de Medicamentos (presentada por la Comisión con arreglo al apartado 2 del artículo 250 del Tratado CE)

    preparatory · ES · 10 December 2002

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  • Proposta modificata di regolamento del Parlamento europeo e del Consiglio che istituisce le procedure comunitarie per l'autorizzazione e la vigilanza dei medicinali per uso umano e veterinario e che istituisce un'agenzia europea dei medicinali (presentata dalla Commissione in applicazione dell'articolo 250, paragrafo 2 del trattato CE)

    preparatory · IT · 10 December 2002

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  • Geänderter Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung von Gemeinschaftsverfahren für die Genehmigung, Überwachung und Pharmakovigilanz von Human- und Tierarzneimitteln und zur Schaffung einer Europäischen Agentur für die Beurteilung von Arzneimitteln (gemäβ Artikel 250, Absatz 2 des EG-Vertrages von der Kommission vorgelegt)

    preparatory · DE · 10 December 2002

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  • Ændret forslag til Europa-Parlamentets og Rådets forordning om fastlæggelse af fællesskabsprocedurer for godkendelse og overvågning for så vidt angår human- og veterinærmedicinske lægemidler og om oprettelse af et europæisk agentur for lægemiddelvurdering (forelagt af Kommissionen i henhold til EF-traktatens artikel 250, stk. 2)

    preparatory · DA · 10 December 2002

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  • Ändrat förslag till Europaparlamentets och rådets förordning om inrättande av gemenskapsförfaranden för godkännande av, säkerhetsövervakning av och tillsyn över humanläkemedel och veterinärmedicinska läkemedel samt om inrättande av en europeisk läkemedelsmyndighet (framlagt av kommissionen enligt artikel 250.2 i EG-fördraget)

    preparatory · SV · 10 December 2002

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  • Τροποποιημένη πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τη θέσπιση κοινοτικών διαδικασιών χορήγησης άδειας, εποπτείας και φαρμακοεπαγρύπνησης όσον αφορά τα φαρμακευτικά προϊόντα που προορίζονται για ανθρώπινη και κτηνιατρική χρήση και για τη σύσταση Ευρωπαϊκού Οργανισμού Αξιολόγησης των Φαρμάκων (υποβληθείσα από την Επιτροπή σύμφωνα με το άρθρο 250, παράγραφος 2 της συνθήκης ΕΚ)

    preparatory · EL · 10 December 2002

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  • Muutettu ehdotus Euroopan parlamentin ja neuvoston asetus ihmisille ja eläimille tarkoitettuja lääkkeitä koskevista yhteisön luvananto-, seuranta-, ja lääkevalvontamenettelyistä ja Euroopan lääkearviointiviraston perustamisesta (komission EY:n perustamissopimuksen 250 (2) artiklan nojalla esittämä)

    preparatory · FI · 10 December 2002

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  • Proposition modifiée de réglement du Parlement européen et du Conseil établissant des procédures communautaires pour l'autorisation, la surveillance et la pharmacovigilance en ce qui concerne les médicaments à usage humain et à usage vétérinaire et instituant une agence européenne pour l'évaluation des médicaments (présentée par la Commission conformément à l'article 250, paragraphe 2 du traité CE)

    preparatory · FR · 10 December 2002

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  • Proposta alterada de Regulamento do Parlamento Europeu e do Conselho que estabelece procedimentos comunitários de autorização, fiscalização e farmacovigilância no que respeita aos medicamentos de uso humano e veterinário e institui uma Agência Europeia de Avaliação dos Medicamentos (apresentada pela Comissão em conformidade com o disposto no n° 2 do artigo 250° do Tratado CE)

    preparatory · PT · 10 December 2002

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  • Gewijzigd voorstel voor een Verordening van het Europees Parlement en de Raad tot vaststelling van communautaire procedures voor het verlenen van vergunningen, het toezicht en de geneesmiddelenbewaking met betrekking tot geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Bureau voor de geneesmiddelenbeoordeling (door de Commissie overeenkomstig artikel 250, lid 2 van het EG-verdrag ingediend)

    preparatory · NL · 10 December 2002

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  • · COM · European Commission

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Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty) — European Union — PoliticalRepo