Do you supply medicines as stock to other healthcare providers or other legal entities by way of wholesale dealing?
You may be aware you need to hold a Wholesale Distribution Authorisation or WDA (H) if you supply medicines as stock to another legal entity, but do you supply Controlled Drugs too?
If yes, you will also require “Narcotic and Psychotropic” as a product class, PLUS CD licences for the supply of CDs in Schedules 2 to 5 from the Home Office.
The application process and persons named on the licence are different from applying for a wholesale licence from the MHRA.
The guidance on controlled drug licences, fees and returns can be found HERE
o Name of Person in Charge
o Person in Charge of Security of the premises
o Authorised Witness
o Site Responsible Person (legal compliance and regulatory affairs)
o Review of a specific list of Standard Operating Procedures which must be in place ( Guidelines for standard operating procedures )
o Review and discussion of a specific list of topics submitted by the Home Office in advance of the inspection
o Review and availability of a specific list of documentation during inspection
Wholesalers and suppliers of CDs must supply the Home Office with annual statistical returns (Annual returns 2015: guidance notes and definitions ) on the specified form (Annual returns form 2015 ) by 31st January each year.
It can take up to FOUR MONTHS to process your Home Office application.
Once you have your inspection and close out any deficiencies you will be revisited on an annual basis to ensure that you are controlling the site and products appropriately.
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This helpful blog was written by Nik Sanghara
Nik Sanghara is an experienced Regulatory Affairs Manager, MHRA and Home Office registered Responsible Person and Pharmacist.
With over 20 years’ experience in the Pharmacy and Pharmaceutical Industry, Nik has worked in Pharmaceutical Manufacturing, Wholesale and Community Pharmacy giving him a holistic view of the Supply Chain from API to patient.
Nik has a close working relationship with industry regulators including the MHRA, Home Office and GPhC and has recently gained Pharmaceutical QMS Auditor registration with IRCA.
13 Mar 2017
24 Feb 2017