We are using this communication to update you and also to answer some FAQs.
Normal update on Unlicensed Medicines (ULMs)
We continue to receive regular reports of additional products that are out of stock or of insufficient/restricted stock in Ireland. As ever, there is often an inconsistent picture across the country, some even across town! Our pricelist is very up to date and has incorporated in recent additions or deletions to the list of products that we are being told are required as ULM in Ireland. Of course, do not rely simply on our list as a reference for what is available or unavailable. Always satisfy yourself first that you cannot obtain a licensed product, before you resort to ordering an unlicensed one.
We have some important current information below, which should be helpful:-
Remember that carriage-paid orders need to come to the value of at least €100.00.
Remember to check availability of licensed product before ordering a ULM.
ALL medicines listed in our pricelist are UNLICENSED in Ireland (the greater majority will be licensed in UK, but NOT in Ireland).
We cannot supply any Controlled Drugs (CDs), including those over the counter products with a low content of CD, eg. Codeine phosphate 8mg.
We cannot supply cold chain products.
You cannot return ULMs once you have placed a genuine order.
We have been able to get / continue to have some supplies of the following ULMs:-
Bendroflumethiazide 2.5mg Tablets 28s
Bendroflumethiazide 5mg Tablets 28s
Betnovate Cream 100mg (as generic)
Betnovate RD Cream and RD Ointment 100g (as generic)
Cimetidine 400mg Tablets 60s
Clove Oil 10ml
Colestyramine 4g SF Sachets 50s
Dioctyl 100mg Capsules 100s
Estradiol 10 mcg Vaginal Tablets 24s (as generic Vagifem)
Labetalol 100mg Tablets 56s
Labetalol 200mg Tablets 56s
Laxido Paediatric Sachets 30s
Nifedipine MR 20mg Tablets 56s
Nifedipine XL 30mg Tablets 28s
Nifedipine XL 60mg Tablets 28s
Norethisterone 5mg Tablets 30s
Propafenone 150mg Tablets 90s (Limited stock)
Propranolol 10mg Tablets 28s
Scopoderm TTS Patches 2s
Utrogestan 100mg (Oral) Capsules 30s
Also, please note that at present we CANNOT get, or CANNOT supply:-
Centyl-K (or Low Centyl-K)
Epilim Chrono Tablets (all strengths)
Evorel or Estradot range (we cannot get any strength or variant in the range)
Fucithalmic Eye Drops 5g (available, but very high price)
Gentisone HC Ear Drops
Parnate 10mg Tablets
Prednisolone Rectal Foam (available, but very high price)
Prednisolone 5mg Soluble Tablets (available, but very high price)
Background, definitions and terminology
Pharmacists should only purchase and supply ULMs (otherwise known as “unauthorised medicinal products”) when they fit within the definition of “exempt medicinal products”.
Subject to certain exemptions, medicinal products which are placed on the Irish market are required to have a Product Authorisation issued by the Health Products Regulatory Authority (HPRA) (reflected by a PA number) or, in the case of centrally authorised products, an authorisation issued by the European Commission, reflected by an EU number (ref: regulation 6 of the Medicinal Products (Control of Placing on the Market) Regulations 2007). Schedule 1 to these regulations includes an exemption for practitioners to prescribe unauthorised medicinal products for individual patients under their direct responsibility, in order to fulfil the special needs of those patients. Such products are defined as “exempt medicinal products”.
The relevant Regulations are:
• Medicinal Products (Control of Wholesale Distribution) Regulations 2007 S.I. 538/2007
• Medicinal Products (Control of Manufacture) Regulations 2007 S.I. 539/2007
• Medicinal Products (Control of Placing on the Market) Regulations 2007 S.I. 540/2007
An ‘exempt medicinal product’ is defined as “a medicinal product to which paragraph 2 of Schedule 1 to the Medicinal Products (Control of Placing on the Market) Regulations 2007, or any equivalent legislation in any EEA State other than the State, applies”. The aforementioned Paragraph 2 of Schedule 1 states that an exempt medicinal product may be sold or supplied
“..in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients…”.
This means that a medicinal product can only be defined as “exempt” when it is supplied to the order of a registered doctor or registered dentist for use by his individual patients under his direct personal responsibility.
Hence, when we receive an order to supply an exempt medicinal product within Ireland we need to obtain confirmation (written or otherwise) that the supply is in response to a “bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients”. It is not a requirement to request details of patient names or patient ID numbers. The practitioner is not required to sign the confirmation.
It is essential that you and all healthcare professionals in the supply chain are aware that exempt medicinal products have not been assessed by the HPRA against the criteria of safety, quality and efficacy, and that the responsibility for the clinical use of such products lies with the prescriber.
For more information, please contact ourselves or the Health Products Regulatory Authority.
How does Brexit affect how you trade with us now?
The answer is – not at all!
The Northern Ireland Protocol (the contentious part of the initial exit deal of 2019) allows for Northern Ireland to have a unique position within the UK with regards medicines and regulation. It will be much more closely aligned with the EU than GB.
It is officially the case, confirmed by HPRA, that the supply of EMPs (ULMs) that has been taking place during the Brexit Transition period last year (2020) can continue after the end of the Brexit Transition period (31st December 2020).
This applies only to wholesalers situated in Northern Ireland and not those in GB. You also will not be able to purchase any medicinal products from them now (unless you hold a Wholesale Dealer’s Authorisation WDA).
Do you need supplies of medicines from GB?
Some of you may have been getting certain medicinal products from GB in the past. This has now been thrown into chaos. We have started to get approaches from some of you on the matter. If you are affected by this, please do contact us and we might be able to help.
Make use of the unique opportunity that exists with us being based in N. Ireland – within the UK, but also within the Single Market for goods.
Please see HSE circular to pharmacy (004/21) dated 11th February 2021 for further information. One direct quote from that circular states:- “In accordance with the Northern Ireland protocol, the changed regulatory requirements for the supply of exempt medicinal products from the UK do not apply to the supply of exempt medicinal products from Northern Ireland to the Irish market.
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