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MAIL 159

Document details:

Type: Publication
Series No: 159
Audience: Pharmaceutical industry
Published: January/February 2007
Format: Electronic and paper
Size: A4
Pages: 25
Price: Electronic free, subscription for print
ISBN/ISSN: 1360-8738
Author: MHRA
Copyright: Crown
   

In this issue:

 Disruptions to the supply of medicines: interpretation of the ‘Sunset Clause’ Interpretation of Article 23a and Article 24 (4-6) of Directive 2001/83EC - the so called ‘Sunset Clause’
Advertising medicines: publication of statistics on prior vetting
Requests for MHRA to act as a Reference Member State (RMS) in decentralised procedures
Reminder - submission of applications/notifications under Article 61(3) for changes to labelling and patient information leaflets (PILs)
National applications under Article 10c - ‘simple abridged’
Marketing authorisation (MA) for diluents and solvents for medicinal products
Provision of anonymised single patient reports (ASPRs) from the MHRA to industry
Periodic safety update reports (PSURs)
British Pharmacopoeia
Orange Guide
Eurodirect guidelines
MLX consultations

Page last modified: 06 February 2007