Wholesaling & Signed Orders

Question 1

Which governing body is responsible for oversight and enforcement of the wholesale distribution of medicines?

Answer 1

The Medicines and Healthcare products Regulatory Authority (MHRA)

Question 2

Anyone trading medicines, aside to a patient, is required to do what? (3)

Answer 2

• Hold a Wholesale Distribution Authorisation (WDA) (License)
• Comply with Good Distribution Practice (GDP) standard and pass regular GDP inspections
• Have a suitably experienced ‘Responsible Person’ named on the license

Question 3

When are WDAs not needed and there are exemptions?

Answer 3

• Pharmacies supplying stock form one to another within the same legal entity
• Pharmacies and hospitals supplying small quantities to HCPs for treatment provided:
  - The transaction is occasional

Question 3

When are WDAs not needed and are there exemptions?

Answer 3

• Pharmacies supplying stock form one to another within the same legal entity
• Pharmacies and hospitals supplying small quantities to HCPs for treatment provided:
  - The transaction is occasional
  - The quantity is small
  - Supply is not made for a profit basis
  - supply is not for onward wholesale distribution

Question 4

Is the wholesale of controlled drugs (CDs) allowed?

Answer 4

Yes - IF they are Sch 2-5, it is likely a corresponding Home Office CD License is required by the pharmacy

Question 5

Must record be kept if supplying from a registered pharmacy to a HCP?

Answer 5

Yes- entry made in the POM register

• OR the signed order needs to be retained for 2 years (GOOD PRACTICE to still make a POM register record)