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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 ...

EMEA: Concept paper on veterinary medicinal products on manure (in this document the term manure)

28.02.2009
EMEA:
Concept paper on veterinary medicinal products on manure (in this document the term manure. The guideline provides a number of options for refinement of the predicted environmental ...

EMEA: Guideline on Dossier Structure and Content for Pandemic Influenza Marketing Authorisation Application

28.02.2009
EMEA:
Guideline on Dossier Structure and Content for Pandemic Influenza Marketing Authorisation Application. This guideline provides the basis for a fast track authorisation procedure for ...

The Polish Office for Registration: The statement of the President of the Office for Registration relating to the notification of withdrawals of the medicinal products

28.02.2009
The Polish Office for Registration:
The statement of the President of the Office for Registration relating to the notification of withdrawals of the medicinal products to the President of ...