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 (CD) 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
– The application must be made via the Home Office portal where you would need to register first (controlled drugs and precursor chemicals registration )
– Each person named on the licence must be Capita Enhanced DBS checked. Compliance site visits will only be arranged with applicants once the Home Office has received confirmation that everyone named on the application has undergone a DBS check. For more information on DBS checks click HERE
– Four key roles must be named in the application process. They are:
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)
– Sites previously not licenced will be inspected by a Compliance Officer from the Home Office Drug Licensing & Compliance Unit. Site inspection will include:
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
– Sites must comply with the General security guidance for controlled drug suppliers and Transporting controlled drugs: guidance on security measures
– Licence fees and renewal dates differ from MHRA wholesale licences (https://www.gov.uk/guidance/controlled-drugs-licences-fees-and-returns#licence-fees ). CD licences must be renewed annually for each site licensed. Open ended or ‘no time limit’ licences are no longer valid.
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.
Need help gaining your CD licence, or to streamlines your procedures? Have issues with your operation or want to know more?
Contact us for a free, no-obligation conversation.
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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.
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