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EMEA: Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines

27.07.2009
In 2002 the Biotechnology Working Party at the EMEA began drafting guidance on the product information (summaries of product characteristics, labelling and patient leaflets) for human ...

EMEA: Revision of Happendix II “Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC

27.07.2009
Revision of Happendix II “Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC Section 4.8 \"Undesirable effects\": minor changes in Italian, Maltese ...

EMEA: Adopted guideline on the Investigation of Medicinal Products in the Term and Preterm Neonates

27.07.2009
This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this ...

EMEA: Community herbal monograph on Althaeae radix

27.07.2009
Finalised documents for the community herbal monograph on Althaeae radix Althaea officinalis L., radix (marshmallow root) ...

EMEA: CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009)

27.07.2009
This document applies to the pharmacovigilance plan as part of the risk management plan introduced with the authorisation application of mock-up pandemic influenza vaccines according to the CHMP ...

EDQM: 134th session of the European Pharmacopoeia Commission

27.07.2009
In its session, the European Pharmacopoeia Commission adopted 91 monographs and 9 general chapters, amongst them a new general chapter on recommendations on dissolution testing (5.17.1) and two ...

European Commission: Variations (codecision part): publication of amendments to Directive 2001/82/EC and Directive 2001/83/EC.

27.07.2009
Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing ...

European Commission: New regulation on Maximum Residue Limits has entered into force

27.07.2009
The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation ...

MHRA: New reclassifications of medicines

27.07.2009
A brief summary of reclassifications that have been approved in the past 12 months. ...

MHRA: Marketing Authorisation applications for medicines using the Decentralised procedure (DCP) with the UK as Reference Member State (RMS): New or earlier slots available in all therapeutic areas

27.07.2009
As a result of cancellations and delays in submissions for booked DCP slots, MHRA has some capacity in all therapeutic areas to offer new or earlier slots to applicants for procedures commencing ...