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MHRA: Guidance on the vigilance system

09.12.2009
This guidance document gives advice to manufacturers on the notification of adverse incidents involving implantable neurostimulators under the Medical Devices Vigilance System. It is intended to ...

EMEA: Traditional herbal medicinal products

01.12.2009
Overview of questions and answers relating to EU pharmaceutical legislation and regulatory aspects applicable to herbal medicinal products ...

EMEA: Guideline on xenogeneic cell-based medicinal products

01.12.2009
Xenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment ...

MHRA: Guidance published on UK national marketing authorisations (MA) variations

01.12.2009
The MHRA has produced guidance to assist those making variation applications to the MHRA as from 1 January 2010, following the implementation of a new Commission Regulation and its adoption for UK ...

EMEA: Note for guidance Eudravigilance Human - Processing of safety messages and individual case safety reports (ICSRs)

25.11.2009
The purpose of this guidance is to describe the aspects of the message processing and acknowledgment generation implemented in EudraVigilance (EV). It updates and replaces the business rules and ...

EMEA: Draft EMEA/pdco standard pediatric investigation plan for allergen products for specific immunotherapy

25.11.2009
The drafting of this standard PIP was triggered by a request from the German Competent Authorities. ...

MHRA: Reclassification of medicines

25.11.2009
MHRA recently changed the legal status and classification of several medicines. ...

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