Authorised Health Professional Status
Of note is that under article 5 EU Directive 2001/83/EC there is provision for authorised healthcare professionals to have finished industrially produced products supplied to them without a marketing authorisation, provided that the practitioner is the initiator of the request, and that such products are intended for supply to individual patients. If such products were for sale to the public directly then a marketing authorisation would be needed.
For this reason, the term “authorised healthcare professionals” is an important phrase. If it can be applied to us, we may be able to have finished herbal products made for us by a third party. To gain rights to this exemption, we must be statutorily-regulated healthcare professionals by April 2011 when the Traditional Herbal Medicinal Products Directive (THMPD) becomes fully implemented. At this time the THMPD will replace Section 12(2) which currently allows the over-the-counter sale and supply of herbal medicines without a product licence.
Another reason why we need to be recognised as authorised healthcare professionals as defined in Directive 2001/83 EC is because if a herbalist currently uses a pharmacy provision which is off site from her / his practice, then technically the herbalist is not covered by section 12(1). Instead the herbalist is currently making use of Section 12(2). As this section 12(2) is being replaced with THMPD in April 2011, for members to continue to enjoy this option, i.e. using an offsite dispensary provision, they need to be registered healthcare professionals under Article 5 of Directive 2001/83/EC. As explained, this is only possible if we are statutorily regulated.
This subject is explored in the MHRA consultation document which can be accessed at:
MHRA Discussion Paper: no. 6 Reforms of s12(1) of the Medicines Act 1968: the regulation of unlicensed herbal medicines commissioned by a registered practitioner from a third party to meet the need of individual patients
www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=659
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