UK Medicine Wholesale Licence Requirements

You apply online to the MHRA through its process licensing (PCL) portal. A standard new WDA(H) costs £6,295: a £2,159 application fee plus a £4,136 inspection fee for one site. After that you pay a £346 annual fee, every April. These are the MHRA fees in force from 1 April 2025, as shown on its fees page updated 21 April 2026.

What the law requires of the application (Human Medicines Regulations 2012)

• Under Regulation 21(1), the application "must" be made to the licensing authority, in the way and form set out in Schedule 3, with the information, documents, samples and other material Schedule 3 lists. Under Regulation 21(2), it must also say which descriptions of medicinal products the licence covers ^[7].

• Schedule 3, paragraph 3(2) requires:

  • the applicant's name and address, and those of anyone applying on its behalf
  • the address of every site where products are stored or distributed from
  • the name, address and qualifications of the responsible person (or the responsible person (import))

• Paragraph 3(3) adds:

  • details of the wholesale activity
  • the authorisation basis of the products: UK MA (GB), MA (NI), certificate of registration, THR, Article 126a authorisation, or an authorisation from a country outside the UK
  • whether the products are POM, P or GSL
  • whether they are specials, EAMS products, regulation 174 supplies, or for export from Great Britain to an approved country for import
  • whether they are for human administration or are ingredients
  • the range of products held at each site, and the storage and distribution facilities and equipment
  • stock turnover arrangements
  • an emergency plan meeting regulation 43(7)(b)
  • record-keeping for products received and dispatched

  ^[8]

• Paragraph 4 sets the form:

  • The application must be in English, with serially numbered pages.
  • It must be signed by the applicant, and also by any agent applying on the applicant's behalf.
  • If something required is left out, the application must say why.

  ^[8]

• Regulation 22(2) lists what the MHRA must consider: the storage premises, the storage equipment, the distribution equipment and facilities, and the safekeeping and record-keeping arrangements ^[9].

• Regulation 23 sets the timing. The MHRA must grant or refuse within 90 days of receiving the application, but only once Schedule 3 is fully met. Time spent answering a regulation 30 information notice doesn't count. If it refuses, it must give reasons ^[10].

What the MHRA's guidance adds (Notes for applicants and holders of a WDA(H) or broker registration, updated 12 September 2025)

• You apply through the PCL portal, and the application isn't processed until the new-application fee is paid.
• Sites are inspected, and you get a GDP certificate for each inspected site.
• The MHRA may check the identities of the responsible person and named staff.
• The guidance says applications "should take 90 working days". That is longer than the regulation's 90 days.
• Refunds if you withdraw:
  • before inspection: 90% of the application fee
  • after inspection: 50% of the application fee, and the full inspection fee stays due unless you withdrew at least 15 days before the inspection

Fees (Current MHRA fees)

Item	Fee
Standard new application with full inspection	£6,295 (£2,159 + £4,136)
Reduced application with full inspection	£5,128 (£992 + £4,136)
Reduced application with reduced inspection (GSL only)	£3,060 (£992 + £2,068)
Each additional site inspected	£4,136
THMP/homeopathic inspection (reduced)	£2,047 (£1,114)
Office-based risk assessment	£3,810
Change of ownership	£478
Standard variation	£652
Administrative variation	£345
Annual fee: standard	£346
Annual fee: reduced rate or GSL	£206

The reduced rate is for:

• dealers in GSL medicines only
• registered pharmacies where wholesale is no more than 15% of turnover
• small dealers with wholesale turnover of no more than £35,000 a year

A broker registration is a separate route. It costs £5,793 to apply (£1,983 application fee plus £3,810 assessment fee).

The veterinary authorisation (WDA(V)) application fee of £344, set by the Veterinary Medicines Regulations 2013 and covered in my last answer, is separate from all of these.

Approach: I read the application rules (regulations 21 to 23 and Schedule 3) in the current revised Human Medicines Regulations 2012. The fee amounts aren't in the legislation I can search, so I took them, and the portal process, from the MHRA's own GOV.UK pages.

You can check a wholesaler against two MHRA public registers. Search the MHRA register of licensed wholesale distribution sites by company name or WDA(H) number. Then open the company's actual licence and its GDP certificate in MHRA-GMDP to see what it may handle and when it was last inspected.

1. Register of licensed wholesale distribution sites (GOV.UK, updated monthly)

• The MHRA publishes this as a CSV on GOV.UK (publication page). The latest version I found is the October 2026 snapshot.
• Each row is one licence linked to one site. It gives:
  • the licence number
  • the licence holder and its company address
  • the site ID, name and address
  • whether the site is a third party's premises
  • flags for the licensed activities
• For example, WDA(H) 10 is held by Bayer plc, Reading. Its listed sites are third-party sites operated by Alloga UK (South Normanton and Sutton-in-Ashfield) and CPG Holdings (Gosport) ^[11][12].
• So check that the address the goods actually come from is listed under the supplier's licence, not just the company name.

2. MHRA-GMDP (the licence itself and GDP certificates)

• The licence. Each WDA(H) is published as a document. It shows:

  • the holder and its registered address
  • every site
  • the legal basis (regulation 18 of the Human Medicines Regulations 2012)
  • the issue date
  • an Annex 1 scope for each site

  The scope is what to check against what you are buying. It covers whether the site may handle products with an authorisation (1.1) or without one (1.2), the operations (procurement, holding, supply), and the categories of product. For example, UK WDA(H) 22287, Right Price (Wholesale) Ltd, Hayes, is limited to "4.3 General Sales List Only". A supplier like that should not be selling you POM or P lines ^[13]. Different sites under one licence can have different scopes. Henderson Wholesale's second site covers products without an authorisation, while its main site is limited to GSL only ^[14].

• The GDP certificate. Each one is tied to a WDA(H) number and gives the date of the latest inspection. It confirms compliance with the GDP requirements in regulation C17. It also says it "should not be relied upon" if more than five years have passed since that inspection, and the MHRA can shorten that period in the restrictions field. The certificate states that its authenticity "may be verified in MHRA-GMDP" ^[15]. Some certificates add remarks, such as a new site being re-inspected within 24 months ^[16].

• I found no GDP non-compliance statements for UK wholesalers in the MHRA-GMDP records I can search.

Checklist for a new supplier:

1. The WDA(H) number appears in the latest monthly register.
2. The site you will receive goods from is listed under that licence.
3. The Annex 1 scope covers the products and categories you are buying (POM/P/GSL, authorised or unauthorised, any import).
4. A GDP certificate exists for that site, and its inspection date is less than five years old.

This is also how a licence holder meets the duty from our earlier discussion: regulation 43 requires holders to check that any broker they use meets the requirements.

If you give me a supplier's name or WDA(H) number, I can run all four checks now.

Approach: I searched the MHRA register of licensed wholesale distribution sites for human medicines (October 2026 snapshot) and the MHRA-GMDP records of wholesale licences and GDP certificates.