EMEA: Mandate, Objectives And Rules of Procedure for the Pharmacovigilance Inspectors Working Group

The PhV IWG will address all matters related directly or indirectly to PhV inspections and carry out the tasks described under section II. The key to its role is the development and implementation ...

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

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

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

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

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

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

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 ...

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