Retail Sale of Herbal
Medicinal Products In Ireland
Scientific Officer, Health Products Distribution Section, Compliance
HPRA Herbal Medicines Information Seminar
14 January 2015
Patrick Walsh
Overview…
• General Sale Medicinal Products List…
• Medicinal Product Restrictions…
• Wholesale Supply of Medicinal Products…
• Guide for Retail Sale of Herbal Medicinal Products…
• HPRA Retail Monitoring…
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General Sale Medicinal Products List…
• General Sale Medicinal Products are herbal and non-herbal medicinal products that can be sold by health stores, pharmacy retailers and other non-pharmacy retailers.
• They are identified in the ‘General Sales Product Information List’ which is available from the HPRA website.
• The most up-to-date list is available at http://www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine.
• The above list does not, however, identify transitionally protected Traditional Herbal Medicinal Products i.e. products that are the subject of an application to register as a THMP and where the application was submitted to the IMB/HPRA before 31 December 2011.
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Medicinal Product Authorisation and Registration
Numbers…
Authorisation /
Registration Number
Explanation
PA0000/000/000 Medicinal Product authorised by the HPRA
HOA0000/000/000
Homeopathic Medicinal Product authorised under
the national rules scheme by the HPRA
HOR0000/000/000 Homeopathic Medicinal Product registered under
the simplified scheme with the HPRA
TR0000/000/000
Herbal Medicinal Product registered as a THMP
with the HPRA
Medicinal Product restrictions…
• Some medicinal products can only be sold
through a retail pharmacy. Some examples are
given below:
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Retail
Pharmacy
Medicinal products
subject to
prescription control
Ibuprofen containing
medicinal products
Prostasan Soft
Capsules TR725/2/1
Sale of more than 1
pack of a
paracetamol
containing product
Wholesale Supply of Medicinal Products… • Registered and Authorised Medicinal Products must only be purchased
through a wholesaler that holds a valid wholesale distribution authorisation issued by the Competent Authority of the Member State where the wholesaler is located.
• A list of Irish-based wholesalers authorised by the HPRA is available on the HPRA website at http://www.hpra.ie/homepage/medicines/regulatory-information/wholesalers-and-distributors.
• Only medicinal products which hold a valid registration or authorisation granted by the HPRA can be sold by health stores and non-pharmacy retailers; unless it is the subject of transitional protection.
• Unregistered or unauthorised medicinal products can no longer be supplied to the Irish market nor sold to Irish consumers.
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Guide for Retail Sale of
Herbal Medicinal Products…
• Published for consultation and is available from the HPRA website at:
• http://www.hpra.ie/homepage/medicines/regulatory-information/consultations
• Comments to:
• Closing date:
• 23 January 2015
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Guide Structure…
• The guide consists of:
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Decision
Tree &
Explanatory
Text
Retailer List A
Retailer List B
Retailer List C
Decision Tree and Explanatory Text:
• To be used in conjunction with Retailer Lists A, B and C.
• Function: to help you navigate through the above retailer lists in order to determine if a herbal product can be legally sold in Ireland.
• Examine the herbal product and follow the steps given in the decision tree whilst reading the explanatory text and searching through the retailer lists.
• Then make a decision.
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Decisions…
Product can be sold…
Product cannot be sold…
Product contains a herbal substance that is considered to be medicinal
by the HPRA and, as such, may require prior registration or
authorisation…
Contact the Food Safety Authority (FSAI): https://www.fsai.ie/...
Contact the Health Products Regulatory Authority (HPRA):
http://www.hpra.ie/...
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Retailer List A:
• Identifies the authorised herbal medicinal
products and registered traditional herbal
medicinal products that may be sold by a
retailer. Also includes the transitionally
protected herbal medicinal products (THMPs).
• Retailer List A contains both General Sale Herbal
Medicinal Products and some Pharmacy-Only
Herbal Medicinal Products.
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Retailer List B:
• Identifies herbal substances, which when present in a herbal product for oral use, renders that product a medicinal product subject to prescription control.
• An oral use product containing a herbal substance on Retailer List B cannot be sold. Refer to Retailer List C if necessary.
• Some herbal substances on Retailer List B when contained in a topical use product (skin, nails, hair, lips) may not render the product a medicinal product. Refer to Retailer List C.
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Retailer List C:
• A number of herbal substances which when contained in a product (for oral use or topical use) may render it a medicinal product and, as such, requires an authorisation or registration prior to it being sold.
• Retailers are encouraged to follow the guidance provided in Retailer List C and, if in doubt, to contact the HPRA or the FSAI for advice.
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HPRA Retail Monitoring…
• Proactive and reactive retail monitoring
programme.
• Functions to promote compliance by monitoring
the possible sale of non-compliant products by
health stores, retail pharmacies and other non-
pharmacy retail outlets.
• Retailers and other operators are, however,
responsible for the products they supply or sell.
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Scope of activity
Areas Monitored
The sale of incorrectly classified consumer products
The sale of medicinal products that do not carry a valid registration
or authorisation number granted by the HPRA
The sale of pharmacy only medicinal products by non-pharmacy
retailers
Non-compliance with the paracetamol regulations
The sale of expired medicinal products
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Case Investigation:
Sale of a UK registered THMP
• Retailer requested to remove product from sale and return to supplier or send for destruction. Evidence of action taken provided to the HPRA plus a reconciliation report (Questionnaire).
• Invoice also requested and reviewed to identify supplier and any other possible non-compliant products.
• 1 high risk product for the treatment of haemorrhoids detected and 1 low risk product detected. Retailer requested to remove the haemorrhoid product from sale and not to replenish the low risk product.
• Supplier follow up via the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
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Case Investigation:
Sale of a Herbal Detox Product
• Product sampled during a retailer inspection and submitted to the IMB/HPRA’s Classification Committee.
• Product determined to be a medicinal product based on claims (diuretic) and composition (herbs with diuretic properties). Product owner advised of the outcome of Classification Committee’s assessment of the product.
• Classification Committee recommended that the product owner amend the packaging and reformulate; otherwise the product could no longer be sold in Ireland without a registration from the IMB/HPRA.
• Additionally, during the retailer inspection a herbal eye drop product was identified. The product was not authorised by the IMB/HPRA and was not certified as a medical device by a notified body. Retailer instructed to remove the product from sale. Follow-up action with the supplier and product owner.
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