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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 ...

MHRA: Code of practice for pack design for over the counter medicines

03.08.2009
Council Directive 2001/83/EC as amended, requires that marketing authorisation holders (MAH) inform the competent authority of all changes to the labelling which are not connected to changes to ...

MHRA: Department of Health consultation on regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine

03.08.2009
A UK-wide consultation on whether practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated was launched on 3 August 2009 by the Department of Health (DH). ...

European Commission: Volume 9B of the Rules Governing Medicinal Products in the European Union: Public consultation on the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use

03.08.2009
The European Commission today launches a public consultation on Volume 9B, the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. Volume 9B has been updated to take account ...

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

31.07.2009
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: Concept paper on the need for a guideline on the clinical investigation of specific immunoglobulins

31.07.2009
Due to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data ...