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Transitional provisions for implementation of Variation Regulation (EC) No 1234/2008

18.12.2009
Further to discussions between the EMEA, European Commission and the CMD(h), the following practical guidance on the transitional provision and entry into force of the Variation Regulation, as ...

Proposal for a Revision of the European Commission Guideline on Summary of Product Characteristics

18.12.2009
Overview of comments received on draft revision 2 of the smpc guideline ...

EMEA: Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

09.12.2009
This guideline is intended to provide guidance for the evaluation of new medicinal products or drugs used in combination in the treatment of pulmonary arterial hypertension PAH. ...

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 ...

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