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EMA: Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits

02.08.2012
This module provides guidance on planning and conducting the legally required audits, and in respect of the operation of the European Union regulatory network, the role, context and management of ...

EMA: Guideline on good pharmacovigilance practices: Module XV – Safety communication

02.08.2012
This module provides guidance to marketing-authorisation holders, competent authorities in Member States and the Agency on how to communicate and coordinate safety information in the European Union. ...

EMA: Guidelines on good pharmacovigilance practices (GVP)

02.08.2012
New legislation for pharmacovigilance will apply in the European Union (EU) as of July 2012, and to support its implementation, a new set of guidelines for the conduct of pharmacovigilance in the ...

EMA: Compilation of Community Procedures on Inspections and Exchange of Information

26.07.2012
The Compilation of Community Procedures on Inspections and Exchange of Information, formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

26.07.2012
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

GMP: GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress

26.07.2012
The US Congress passed the so-called \"Generic Drug User Fee Act\" (GDUFA). This act allows the FDA to charge Generic Drug companies who submit a marketing authorisation application for generics ...

EMA: Draft Quality Review of Documents human product information annotated template: revision of the product information

19.07.2012
The purpose of this revision of the Quality Review of Documents human product information is to implement the new provisions from the pharmacovigilance legislation. This consultation aims to ...

EMA: Adopted guideline on setting specifications for related impurities in antibiotics

19.07.2012
This guideline has been developed in order to provide guidance on how specifications for related impurities in antibiotics that are fermentation products or semi-synthetic substances derived from ...

GMP: Revised Guideline on Renewals in the Centralised Procedure Effective

19.07.2012
The document describes a 120-day timetable presenting the respective actions at specific times which the applicant must observe. Moreover, the Guideline provides detailed information on the ...

EMA: Guideline on Active Substance Master File Procedure

19.07.2012
This Guideline is intended to assist Applicants/MA holders in the compilation of the active substance section of their dossiers for a Marketing Authorisation Application (MAA) or a Marketing ...