Retail Sale of Herbal Medicinal Products In...
Transcript of Retail Sale of Herbal Medicinal Products In...
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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