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Sourcing Medicines for the Great Britain Market from an Approved Country for Import or Northern Ireland from 1 January 2021

If you hold a wholesale dealer's licence it will remain in force from 1 January 2021. If you do not hold a wholesale dealer's licence before 1 January 2021, in order to wholesale deal medicine, you will need to apply for a wholesale dealer' licence. An EEA manufacturer or wholesaler may only supply a licensed medicine to a wholesaler in Great Britain.

The requirement to name an RPi on the wholesale dealer's licence will apply immediately to all new licence applications made from 1 January 2021. If you import a UK or Great Britain authorised medicine from a country on the list, you will need to hold a wholesale dealer's licence that authorises import.

If the medicine is not licensed in the UK or a listed country, you will need an ordinary Responsible Person and not an RPI. 1.2 Without "an authorisation" (a UK or GB Marketing Authorisation, certificate of registration or traditional herbal registration) in the UK and intended for the UK market.

You will need a wholesale dealer's licence that authorises import.  importing medicine from a country on the list for supply to the Great Britain Parallel Import market. Product licence numbers will be marked with a '(UA) suffix on the packaging and summary of product characteristics.

If you source a medicine with a '(UA)' suffix it may only be purchased from: a Northern Ireland manufacturer or wholesaler (a 'qualifying business') a wholesale dealer in Great Britain.

If you source a medicine with a marketing authorisation from Northern Ireland for supply to the Great Britain Parallel Import market or for export to a third country, you will need a wholesale dealer's licence. Sourcing biological medicines -A Northern Ireland manufacturer or wholesaler who supplies a biological medicine to Great Britain will need to confirm that a national batch release certificate has been issued by NIBSC for each batch.

Source: MHRA guideline on  Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021

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