Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious to medicinal products
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD)
Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XIII Medicinal Products
Joint committee decision (JCD)
074/1999
In force in the EEA
Yes
Legal Documents
Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious to medicinal products
Reglugerð framkvæmdastjórnarinnar (EB) nr. 540/95 frá 10. mars 1995 um fyrirkomulag á skýrslugjöf um meintar, óvæntar, en ekki alvarlegar, aukaverkanir lyfja sem ætluð eru mönnum eða dýrum og leyfð hafa verið í samræmi við ákvæði reglugerðar ráðsins (EBE) nr. 2309/93, hvort sem þeirra verður vart í bandalaginu eða í þriðja landi
Verordnung (EG) Nr. 540/95 der Kommission vom 10. März 1995 zur Festlegung der Bestimmungen für die Mitteilung von vermuteten unerwarteten, nicht schwerwiegenden Nebenwirkungen, die innerhalb oder außerhalb der Gemeinschaft an gemäß der Verordnung (EWG) Nr. 2309/93 zugelassenen Human- oder Tierarzneimitteln festgestellt werden
Kommisjonsforordning (EF) nr. 540/95 av 10. mars 1995 om fastsettelse av nærmere regler for rapportering av antatte uventede, uønskede virkninger som ikke er alvorlige og forekommer i Fellesskapet eller i en tredjestat, av legemidler for mennesker og dyr godkjent i samsvar med rådsforordning (EØF) nr. 2309/93
History
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