Ireland’s drugs regulator, the Irish Medicines Board, receives more requests to act as the reference member state (RMS) in the EU’s decentralized procedure than it can handle.
It has therefore come up with a novel solution - it will only accept requests to act as a RMS in the decentralized procedure during one-month periods, or "windows", that are open at least once every year.
That “window” of opportunity for product filings in the second to fourth quarter of 2011 opened on September 1, and will remain open until September 30. A €1,000 booking fee will secure a slot if the IMB confirms that it is available.
The IMB says that it may have further rounds of window opening if it has surplus capacity, either in overall terms or for specific types of products.
It warns pharmaceutical companies that a new submission will be necessary if they change the active substance or dosage form in any decentralized procedure application.
John Davis (j.davis@elsevier.com)
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