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EMEA: Scientific Guideline on the minimum quality and non-clinical data for certification of Advanced Therapy Medicinal Products

05.08.2009
This guideline addresses the scientific content of an application for certification of quality and non-clinical data, and in particular intends to define the minimum data content for the ...

EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics

05.08.2009
In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following CHMP’s ...

EMEA: Guideline on Clinical evaluation of diagnostic agents

05.08.2009
The revision of the points to consider on diagnostic agents was decided in order to reflect better the necessary steps in development of diagnostic agents as well as to define the assessment of ...

EMEA: Guideline on the Clinical investigation of recombinant and human plasma-derived factor VIII products

05.08.2009
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor VIII products is made for use in treatment and ...

EMEA: Guideline on the Clinical investigation of recombinant and human plasma-derived factor IX products

05.08.2009
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor IX products is made for use in treatment and ...

EMEA: Core SPC for pandemic influenza vaccines

04.08.2009
This harmonised SPC has been developed by the VWP in order to facilitate the submission of the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based upon this ...

EMEA: Draft Community herbal monogaph: Mate folium

04.08.2009
Draft Community herbal monogaph and draft list of references on: Mate folium Ilex paraguariensis St. Hil., folium (maté leaves) ...

EMEA: Draft Community herbal monogaph: Echinaceae purpureae radix

04.08.2009
Draft Community herbal monogaph and draft list of references on: Echinaceae purpureae radix Echinacea purpurea (L.) Moench., radix (purple coneflower root) ...

EMEA: Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS)

04.08.2009
Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS) (veterinary medicines) ...

EMEA: Commission regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council

04.08.2009
Commission regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of ...