Guidance on the homeopathic medicinal products …

SPECIFIC GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER Introduction With the implementation of Directive 2001/83/EC as amended all Member States of the

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Packaging ‘blue-box’ requirements for products …

CMDv GUI-027 _ addition CP EMA/CMDv/391895/2012 Page 1 of 42 . CMDv-GUI-27 EMA/CMDv/391895/2012 . Version 072904/101/2014 . Packaging ‘blue-box’ requirements for products authorised via

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Packaging ‘blue-box’ requirements and additional ...

Legal Status For medicinal products restricted to special prescription (narcotics), a number code assigned by the Minister of Health and a double red line are mandatory.

  Medicinal

BEST PRACTICE GUIDE for Veterinary Decentralised …

BEST PRACTICE GUIDE . for . Veterinary Decentralised Procedure (DCP) Edition number: 05 . Edition date: 7 November 2013 . Implementation date: 6 February 2006

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CONSULTATION WITH TARGET PATIENT GROUPS …

consultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging

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CMD(h) BEST PRACTICE GUIDE ON THE …

BPG on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures Rev.5, November 2008 Page 2/11 The principle applies that the marketing authorisation holder may apply for a renewal earlier than

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DECENTRALISED PROCEDURE MEMBER STATES’ …

DECENTRALISED PROCEDURE MEMBER STATES’ STANDARD OPERATING PROCEDURE October 2005 Final Revision 1 November 2007 TABLE OF CONTENTS Abbreviations.....1

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FLOW CHART OF THE DECENTRALISED …

Flow Chart of the Decentralised Procedure 25 July 2005 Page 1/3 FLOW CHART OF THE DECENTRALISED PROCEDURE 1. Issue The Heads of Medicines Agencies (HMA) together with MRFG and VMRFG have

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CMDv/BPG/003 Best Practice Guide For The Repeat …

In case of electronic submissions the “Guideline on the specifications for provision of an electronic submission (esubmission) for a veterinary medicinal product- should be ”

  Product

FLOW CHART FOR THE MUTUAL RECOGNITION …

FLOW CHART FOR THE MUTUAL RECOGNITION PROCEDURE May 2007 Approx. 90 days before submission to CMS Applicant requests RMS to update Assessment Report (AR) and allocate

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Pakkausseloste: Tietoa käyttäjälle ... - spc.fimea.fi

3 Jos olet ottanut liian suuren lääkeannoksen tai vaikkapa lapsi on ottanut lääkettä vahingossa, ota aina yhteyttä lääkäriin, sairaalaan tai Myrkytystietokeskukseen (puh. 09 471 977 Suomessa, 112 Ruotsissa)

  Ifema

1. LÄÄKEVALMISTEEN NIMI 2. VAIKUTTAVAT ... - spc.fimea.fi

potilaalle on ensiannoksen jälkeiseen tarkkailuun kiinnitettävä ristiallergiavaaran vuoksi erityistä huomiota. Levomepromatsiini voi olla haitallinen antikolinergiselle vaikutukselle herkille potilaille, kuten

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PAKKAUSSELOSTE Losatrix Comp 100 mg/12,5 mg ... - Fimea

1 PAKKAUSSELOSTE Losatrix Comp 100 mg/12,5 mg kalvopäällysteiset tabletit losartaanikalium / hydroklooritiatsidi Lue tämä pakkausseloste huolellisesti, ennen kuin aloitat lääkkeen käyttämisen, sillä se

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(Pharmaceutical Inspection Convention and Pharmaceutical ...

Introduction: PIC/S is a combination term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.

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Pakkausseloste: Tietoa käyttäjälle Coldrex kaksikerrostabletti

Pakkausseloste: Tietoa käyttäjälle Coldrex kaksikerrostabletti asetyylisalisyylihappo, guaifenesiini, kofeiini ja askorbiinihappo Lue tämä pakkausseloste huolellisesti, ennen kuin …

INDUSTRIAL SERIES - Brevini UK

INDUSTRIAL SERIES INDUSTRIAL SERIES Brevini Power Transmission S.p.A. - 42124 REGGIO EMILIA - Italy - Via Degola,14 Tel. +39 0522 9281 - Fax + 39 0522 928300 - info@brevini.com - …

Member states contact points for translations review

Title: Member states contact points for translations review Author: European Medicines Agency Created Date: 20190218125610Z

NCAs and EMA requirements for submission of PSUR during ...

NCAs requirements for PSUR submission during the transitional period EMA/333609/2012 Page 2/17 where the medicinal products have been authorised, to the PRAC rapporteur of …