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EMEA: Corrected Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework

25.03.2009
EMEA:
Corrected Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. This paper describes and define the different guidelines that ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

EMEA: Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs

25.03.2009
EMEA:
Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs. The purpose of this document is to streamline and ...

MHRA: Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)

25.03.2009
MHRA:
Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)
MHRA have revised and ...

MHRA: EU Paediatric Regulation: Revised guidance on undertaking the compliance check

25.03.2009
MHRA:
EU Paediatric Regulation: Revised guidance on undertaking the compliance check. Marketing Authorisation holders are reminded that the obligation for applications for new indications ...

HMA: eCTD Implementation Survey Report

25.03.2009
HMA:
eCTD Implementation Survey Report (covering the period from July 2007 to June 2008) (607.58 kb) March 2009. ...

European Commision: Implementation of the Variations Regulation

25.03.2009
European Commision:
Implementation of the Variations Regulation. Public Consultation Paper for the preparation of guidelines on the operation of the variation procedures. ...

FDA: Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format

25.03.2009
FDA:
This guidance is intended to assist applicants in preparing the Clinical Pharmacology section of product labeling to meet the requirements of FDA regulations (21 CFR 201.57) and to ...

EMEA: Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1

28.02.2009
EMEA:
Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1.
This ...