The Urology Company Specials
Driven by quality solutions for pharmacists, doctors, hospitals and patients.
The Urology Company Ltd develops innovative urological solutions for doctors, pharmacists and hospitals in response to meet patients needs where the usual formulation just won’t do.
We work alongside MHRA accredited facilities to supply medicines for patients called ‘Specials’ – also known as unlicensed medicines.
We provide a responsive service with guaranteed next day delivery across a range of urologically active products. Quality matters: It’s at the heart of what we do.
Obtaining a Special from The Urology Company
If you are interested in The Urology Company Specials then please register with us now and we will contact you as soon as possible.
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Who can prescribe a special
A ‘Special’ is a pharmaceutical product that is defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as:
‘a relevant medicinal product supplied to fill a ‘special need’ and in response to a bona fide unsolicited order, formulated in accordance with the specification of a doctor, dentist or supplementary prescriber and for use by his individual patients on his/her direct responsibility’.
Some patients may have particular clinical needs that cannot be met by licensed medicinal products, and pharmaceutical Specials allow Healthcare Professionals to meet these needs.
(see schedule 1 of The Medicines for Human Use Regulations 1994 {SI 1994/ 3144})
UK Law allows an authorised Healthcare Professional to commission the manufacture of an unlicensed medicinal product (a Special) to meet the special needs of an individual patient under his own direct personal responsibility.
If a ‘Special’ is manufactured in the UK, the manufacturer must hold a Manufacturer’s Specials License issued by the MHRA. In addition, The Urology Company as the supplier/ distributor must hold a Wholesale Dealers License (WL). The Urology Company’s WL number is WL36421.
Specials are manufactured to a quality standard in a facility that was approved by the MHRA. The Urology Company outsources its manufacturing to approved Specials manufacturers.
Manufacturers are strictly governed by the MHRA Guidance note 14: The supply of unlicensed relevant medicinal products for individual patients (Revised January 2008). The Urology Company aims to provide useful information with each Special for both the prescriber and the patient, such as appropriate administration and suitable storage conditions but a full Summary of Product Characteristics is not a requirement
An example of a patient information leaflet (PIL) is provided here . Essential records must be kept by the Manufacturer and The Urology Company as the supplier. Serious adverse drug reactions must also be reported to the MHRA. For further information please refer to the Safety Reporting and Medical Information Sections below.
The doctor must report any serious suspected adverse drug reactions to the MHRA (Section 9 Guidance note 14 – using the Yellow Card form (http://www.yellowcard.gov.uk)). With a Special there is no summary of product characteristics as there is with a licensed product and so the prescriber takes full responsibility in law for any adverse effect caused by the medicine unless it can be proven that the medicine is faulty. See also ‘Medical Information’.
In the event of an adverse reaction, or for general medical information enquiries, please contact our medical information department on:
0203 077 5400
info@theurologyco.com
Useful websites:
MHRA website: www.mhra.gov.uk
MHRA Guidance Note No.14: The supply of unlicensed relevant medicinal products for individual patients. Revised January 2008
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For further information on this and other products from the Urology Company contact us at info@theurologyco.com
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