Is your scope of Wholesale Distribution Authorisation (WDA) out of date? – Are you aware that the Wholesale Distribution Authorisation (WDA) categories have changed?
Since Brexit, the MHRA have been making changes to the wording on all WDAs. Whilst you will not receive a physical copy with updated wording, if you check your WDA on the CMS MHRA database the wording has been adjusted automatically.
What are the changes?
Medicinal product categories you intend to handle:
1.1:
Old: With a Marketing Authorisation in EEA member states
New: With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)
1.2
Old: Without a Marketing Authorisation in EEA member states and intended for the EEA Market
New: Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market
1.3
Old: Without a Marketing Authorisation in the EEA and not intended for the EEA market
New: Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in the UK and not intended for the UK market
1.4 is a new category: With a Marketing Authorisation in EEA member state(s) and intended for the GB parallel import market
Authorised Wholesale Distribution Operations:
Old: Procurement, Holding, Supply and Export
New Procurement, Holding, Supply, Export of products to country on a list, Export to a countries not on a list, Products imported from countries on a list, Products certified under Article 51 of Directive 2001/83/EC and Products not certified under Article 51 of Directive 2001/83/EC.
What does this mean?
Depending on your business model pre-Brexit your WDA’s scope ensured all activities you carried out were listed. However, since Brexit the wording of your categories would have changed potentially without you being aware of the change. Therefore, when your customers and suppliers carry out a check on your company you may no longer be operating within your scope.
Examples:
- If your business model was to procure licensed medicinal products from the EEA and distribute to Gambia. Before Brexit you would have required 1.1 and export. However, you will now require 1.1/1.3 depending on if the product is recognised as licenced in the UK, Products imported from countries on a list, Products certified under Article 51 of Directive 2001/83/EC and Export to a country not on the list. As well as a Responsible Person for Import.
- If your business model was to procure licensed medicinal products from the EEA and distribute to EEA. Before Brexit you would have only needed 1.1. Now you will need 1.1./1.3 depending on if the product is recognised as licenced in the UK, products imported from countries on a list, Products certified under Article 51 2001/83/EC and Export to a country on the list. As well as a Responsible Person for Import.
- If your business model is to buy from the UK and distribute to the EEA before you would not have needed export on your licence now you would need Export to country on a list.
Make sure you check your scope now and ensure that any variation required is submitted to rectify any issues identified. Failure to do so could mean you are operating outside the scope of your licence and as such could lead to a critical finding and a suspension of operating. Act now!
If you need help assessing your scope of licence contact Pharmacy Consulting now to assist.