News
MHRA: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
13.08.2010
In July/August 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of eight Article 45 work-sharing
...
EMA: Scientific guideline: Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines
11.08.2010
The objective of this guideline is to provide recommendations on the quality, non-clinical and clinical
studies that should be performed in order to obtain marketing authorisation of a live
...
EMA: Scientific guideline:\'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)\' (EMEA/CHMP/EWP/431734/2008)
11.08.2010
Overview of comments received on \'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder ...
EMA: Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)
11.08.2010
This Guideline is intended to provide guidance on the
evaluation of new medicinal products in ADHD with focus on the childhood onset. It is the first
guideline written in psychiatry to address a
...
CMDh: CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
11.08.2010
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 ...
CMDh: CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE
11.08.2010
Commission Regulation (EC) No. 1234/2008 is effective 1 January 2010 and replaces 1084/2003/EC. It concerns variations in the Mutual Recognition procedure and Centralised procedure. Since the
...
Polish Office for Registration: The statement of the President of the Office for Registration relating to bioequivalence of the generic medicinal products
04.08.2010
The statement of the President of the Office for Registration relating to bioequivalence of the generics with reference to original medicinal products. ...
Polish Ministry of Health: Regulation project relating to application form related to the registration matters (renewals or shortening of registration)
04.08.2010
Regulation project relating to application form related to the registration matters (renewals or shortening of registration) ...
MHRA: Labelling of medicines: Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)
04.08.2010
The legislation provided a transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force on 30 October
...
MHRA: Maintenance of Active Pharmaceutical Ingredient (API) and other sites named on marketing authorisations
04.08.2010
Marketing and manufacturing authorisation holders are reminded that as all sites named on approved marketing authorisations (MAs) can be used for the activity they have been registered for without
...