Looking back, looking forward

Published: 1-Aug-2004


As we enjoy the days of 'so-called' summer (at least if you are in the UK at the moment - wet and windy in early July in London as I write) it's a good time to take stock of what has happened over the last six months and also to look forward to what we can expect for the remainder of 2004.

The Clinical Trials Directive came into force (in most Member States) on 1 May and we are all working through the practical implications of that. There are still obvious differences in interpretation between Member States, but I hope that as we address the realities of applying the Directive these will be resolved.

The 'Future Medicines Legislation' became EU law in March of this year and will become effective as of October 2005.

The packaging and labelling provisions of this have been mentioned already in this column and will no doubt be covered in more detail as we progress.

Also we have welcomed many more Member States into the European Union since 1 May, and the practicalities of working in a Union of 25 members will have to be a priority for each of us - both old and new members. It presents many challenges but also many opportunities for us all.

Looking forward for the rest of the year, it will no doubt be one of consolidation for the new expanded EU and of activity for the industry in meeting the provisions of the 'Future Medicines Legislation'.

If you read this before you go on vacation - have a good holiday - if after, I hope you had a good break.

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