Wholesale supply of medicines: licence requirements

Over-the-counter (OTC) medicines Wholesaling
Contents hide
1 Requirement to hold a wholesale dealer’s authorisation (WDA)
2 Conditions attached to a WDA
3 Types of wholesale dealer’s authorisation
4 Exemptions from the requirement to hold a WDA
4.1 Supply within the same legal entity
4.1.1 Examples where a WDA is not required
4.1.2 Examples where a WDA is required
4.2 Named premises on a WDA
5 How to check whether a company holds a Wholesale Dealer’s Authorisation (WDA)
5.1 MHRA wholesale dealer register
6 What to check on the register
7 If a company does not appear on the register
8 Small-scale and occasional supply exemptions
9 Relationship with former Medicines Act provisions

The wholesale supply of human medicinal products in the UK is governed primarily by the Human Medicines Regulations 2012 (as amended):https://www.legislation.gov.uk/uksi/2012/1916 Requirement to hold a wholesale dealer’s authorisation (WDA) Under regulation 18 of the Human Medicines Regulations 2012, a person may not engage in the wholesale distribution of medicinal products unless they hold a wholesale…

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