Implementation of the Traditional Herbal Medicines Products Directive [2004/24/EC] and the establishment of the Traditional Herbal Medicinal Products Registration Scheme

31 August 2007

The national regulations required to implement the Traditional Herbal Medicinal Products Directive [2004/24/EC] are now in place.

The Medicinal Products (Control of Placing on the Market) Regulations 2007 [SI No. 540 of 2007] came into force on the 23rd July 2007.

Following on from this the IMB is pleased to announce that the Traditional Herbal Medicinal Products Registration Scheme is now available for applicants to apply for certificates of traditional-use for relevant herbal medicinal products.

Applications to the Traditional Herbal Medicinal Products Registration SchemeInformation and guidance on making an application to the scheme is now published in the Publications section of the IMB website www.imb.ie

Applications should be addressed to:

Receipts and Validation Section,
Irish Medicines Board,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2.

Timeframe for implementation of the Traditional Herbal Medicinal products registration SchemeAccording to the Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540 of 2007), on the coming into force of the regulations no medicinal product can be placed on the market without a prior marketing authorisation or certificate of traditional-use registration. However, the regulations provide an exemption from this requirement until 30th April 2011 for traditional herbal medicinal products that were on the market in the State on the coming into force of the regulations.

Notwithstanding the above and in order to ensure that relevant products hold either a marketing authorisation or a certificate of traditional-use registration by the 30th April 2011, potential applicants should be aware that the new regulations also include a provision for the IMB to establish dates by which applications for traditional-use registration must be submitted.

Further information on the legislation and registration scheme are available in the form of a FAQ documents available on the IMB website.  Any further queries on the above can be put in writing to Dr. Cora Nestor at the below address or sent via e-mail to herbalmedicines@imb.ie