wholesale dealing

Question 1

what is the definition of wholesale dealing?

Answer 1

The selling of a medicinal product is classed as ‘wholesale dealing’ if it is sold to a person who:

a) sells or supplies it to someone else, or
b) administers it to someone else in the course of their business

Question 2

what does wholesale dealing involve?

Answer 2

• In other words they do not take or use the product themselves
• It is a sale so money must change hands
• It is nota transfer of stock within an organisation

Question 3

who needs a wholesale dealers license?

Answer 3

Any organisation that wholesale deals medicines needs a Wholesale Dealer’s Licence from the MHRA

Question 4

what is the purpose of a wholesale dealers license?

Answer 4

• Quality control of the process of the distribution of medicines •Good Distribution Practice (GDP)•Named responsible person to ensure correct procurement, storage and distribution of medicines
• Control over who may be supplied
• Aims to promote confidence in the medicine supply chain

Question 5

why are pharmacies sometimes excempt from getting a whole sale dealers license?

Answer 5

the MHRA will not deem such transactions as commercial dealing and pharmacies will notbe required to hold a Wholesale Dealer’s Licence

Question 6

what guidance do the mhra give to pharmacy wholesale dealing?

Answer 6

• Takes place not more than on an occasional basis and
• The quantity supplied is small and
• The supply is made on a not for profit basis and
• The supply is not for onward wholesale distribution

Question 7

who may may a retail pharmacy wholesale deal medicines to?

Answer 7

• Sales of POM and P medicines may onlybe made if the purchaser is authorised to sell or supply the goods or to administer them to human beings in the course of their business or professional practice•e.g. practitioners (e.g. doctor, dentist), another retail pharmacy, hospital or health centre, ophthalmic opticians
• Health Authority or Special Health Authority
• Persons supplying under a PGD
• Many, many others (the MEP contains a limitedlist of people)

Question 8

what are the legal requirements that must appear on a requisition?

Answer 8

there are no legal requirements for the details that must appear on a requisition for a POM (unless it is a CD –see CD lecture)

Question 9

is it a legal requirement for pharmacies to label the stock?

Answer 9

no

Question 10

when must a POM register entry be made?

Answer 10

• No legal obligation to make a record in the POM register so long as the signed order is kept for 2 years from the date of supply but it is good practice to make a record in the POM register (andkeep the invoice for 2 years)
• If there is no signed order then legally a POM register entry must be made

Question 11

what are the legal required details on a POM register?

Answer 11

Date when POM was sold
•Name, quantity, pharmaceutical form and strength of the medicine supplied
•Name, address, trade, business or profession of the purchaser
•Purpose for which the POM is sold or supplied