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EMEA: Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease

28.02.2009
EMEA:
Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease. Introducing a new guideline in a field where no such ...

EMEA: Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population

28.02.2009
EMEA:
Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population. This reflection paper, reflecting experience from recent ...

EMEA: Guideline on Xenogeneic Cell-based medicinal products

28.02.2009
EMEA:
Guideline on Xenogeneic Cell-based medicinal products. This Guideline addresses the scientific requirements for xenogeneic cell-based medicinal products for human use. ...

EMEA: Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs)

28.02.2009
EMEA:
Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs). Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU. ...

EMEA: Updated EMEA Post-Authorisation Procedural Advice Guidance

28.02.2009
EMEA:
Updated EMEA Post-Authorisation Procedural Advice Guidance. Questions & Answers ...

EMEA: Appendix II of Quality Review of Documents (QRD)

28.02.2009
EMEA:
Appendix II of Quality Review of Documents (QRD). Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC Section 4.8 \"Undesirable effects\" ...

EMEA: Calls for submission of scientific data relating to the assessment of: Prunus spinosa L.

28.02.2009
EMEA:
Calls for submission of scientific data relating to the assessment of: Prunus spinosa L.
The HMPC invites all interested parties1 to submit any scientific data, which may be ...

EMEA: Calls for submission of scientific data relating to the assessment of: Cichorium intybus L.

28.02.2009
EMEA:
Calls for submission of scientific data relating to the assessment of: Cichorium intybus L.
The HMPC invites all interested parties1 to submit any scientific data, which may ...

EMEA: Updated inventory of herbal substances for assessment

28.02.2009
EMEA:
Updated inventory of herbal substances for assessment. The table of herbal substances. ...

EMEA: Updated overview of status of HMPC assessment work

28.02.2009
EMEA:
Updated overview of status of HMPC assessment work - priority list ...

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