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Cosmetics - A New Scheme for Regulation by Irish Medicines Board

DATE: 23.06.2011


In 2007, a project to transfer the regulation and control of cosmetic products in Ireland to the Irish Medicines Board (the “IMB”) was announced. The process envisaged the shifting of responsibility in this area to the IMB in consultation with the Department of Health and Children by 2010. This transfer came into effect on 1 October 2010, following the publications of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (Certain Provisions) (Commencement Order) 2010 (SI No 441 of 2010).

Under the scheme, the IMB will be responsible for a range of functions in respect of cosmetic regulation, including cosmetic product notifications, granting of Certificates of Free Sale for export purposes and the operation of a market surveillance system comprising of sampling, monitoring and inspection in general. The Board will also assume responsibility for assuring compliance with and enforcement of legislation, as well as the participation in international and EU based forums on cosmetics.

The scientific and technical strength of the IMB renders it aptly placed to regulate this area, as does its links with other internationally based regulatory authorities. The control of cosmetics will become part of the new Healthcare Products Distribution Section overseen by the Compliance Department of the IMB. Pat O’Mahony, Chief Executive of the IMB has endorsed the initiative in stating:

“The IMB has been working closely with the Department of Health and Children in preparation for this and we are delighted to progress to the stage of formal transfer. We are looking forward to developing our role in the regulation of cosmetic products and, in particular, our interaction with all stakeholders.”

The IMB has been particularly proactive in the context of the transfer. It held an information day in September of this year and is due to organise another such event in order to advise stakeholders on the regulatory framework for cosmetics and the overall role of the IMB. This information day is intended to coincide with the implementation of Regulation 1223/2009, which will come into force in Ireland in 2013. The Regulation is effectively a recasting of the old Cosmetics Directive, designed to simplify the rules and procedures with regard to the marketing of cosmetic products in the EU. The provisions of the Regulation will inevitably render compliance a significant aspect of the IMB’s new role in the cosmetics field.




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