Guidance

Sourcing medicines for the UK market

Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• Last updated: 30 December 2024 바카라 사이트� See all updates

1. Overview听

This guidance covers the sourcing of medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK and should be read alongside any relevant related guidance.听

2. Importing authorised medicines into the UK from a source which is on the approved country for import list听

The Human Medicines Regulations 2012 refers to a list of approved countries for importing medicines under a wholesale dealer바카라 사이트檚 licence. The UK accepts qualified person (QP) certification from the countries on the list. See further information on the approved country list.听

QP certified medicines from the European Economic Area (EEA) are recognised and accepted in Great Britain (England, Wales and Scotland) if certain checks are made. These checks are explained in guidance on바카라 사이트�Acting as a responsible person for import. These medicines will not require re-testing or re-certification by a UK QP if imported and checked by a wholesale dealer in Great Britain.听

If you hold a wholesale dealer바카라 사이트檚 licence for such purposes it remains in force.听

Medicines sourced from Northern Ireland for supply into Great Britain do not require responsible person for import (RPi) oversight. Companies in Northern Ireland may procure UK or European livery medicines from the EEA without the need for an RPi or independent verification of EU QP certification. Wholesalers located in Northern Ireland will continue to hold wholesale dealer licences issued by the UK, and also EU wholesale dealers authorisation (WDA(H)) in line with EEA territories and will not require additional licences.听

Under a GB WDA you may wholesale dealer import medicinal products into GB from a country which is on the approved country for import list provided that the licence authorises the following:听听

• products imported from countries on a list听

• products certified under Article 51 of Directive 2001/83/EC听

• a named RPi who will carry out specific functions听

2.1 Wholesale dealer licence categories related to the authorisation status of medicinal products바카라 사이트�바카라 사이트�바카라 사이트�听

바카라 사이트�바카라 사이트�바카라 사이트婽here are several wholesale dealer licence categories that you can apply for. These include:바카라 사이트�바카라 사이트�바카라 사이트�听

• 바카라 사이트�바카라 사이트�바카라 사이트媍ategory 1.1: with 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)바카라 사이트�바카라 사이트�

• 바카라 사이트�바카라 사이트�바카라 사이트媍ategory 1.2: without 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in Great Britain and intended for the UK market

• 바카라 사이트�바카라 사이트�바카라 사이트媍ategory 1.3: without 바카라 사이트渁n authorisation바카라 사이트� (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

• 바카라 사이트�바카라 사이트�바카라 사이트媍ategory 1.4: with a marketing authorisation in EEA member state(s) and intended for the GB parallel import market

An RPi is not required if the medicine imported from the listed country is not licensed in the UK or the listed country and the medicinal product is either for use as a special medicinal product or is to be exported by the importer. This is because of an exemption in relation to the need for an RPi. Organisations in Northern Ireland do not require an RPi.听听

础苍바카라 사이트�EEA바카라 사이트痬anufacturer or wholesaler may only supply a licensed medicine to a wholesaler in UK. The sale and supply to an authorised person (hospital, doctor or retailer) must be from a UK licensed wholesaler.听

3. Importing human medicines from a country on the list 바카라 사이트� for use as a special medicinal product听

If you import a medicine into GB from a country on the list, for use as a special medicinal product, you will need to hold a wholesale dealer바카라 사이트檚 licence that authorises import.听

Wholesalers located in Northern Ireland will continue to hold licence categories in line with EEA territories and will not require additional licence categories. Companies in Northern Ireland may procure medicines from the EEA without the need for an RPi or independent verification of EU QP certification.听听

3.1 Importing medicines licensed in the listed country into Great Britain as unlicensed medicines听

If you are importing a medicine that is licensed in the listed country, you will need an RPi.听

Your wholesale dealer바카라 사이트檚 licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:听

• category 1.2: without 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in Great Britain or바카라 사이트�EEA바카라 사이트痑nd intended for the UK market

This licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products certified under Article 51 of Directive 2001/83/EC听

罢丑别바카라 사이트�current notification of intent to import an unlicensed medicine바카라 사이트痳emains the same.听

Further information on licence categories is available in The Green Guide and Notes for applicants and holders of a Wholesale Dealer바카라 사이트檚 Licence (WDA(H)) or Broker Registration.听

3.2 Importing medicines not licensed in the listed country听

If the medicine is not licensed in the UK or a listed country, you will need a responsible person (RP) as defined in the Human Medicines Regulations 2012, Regulation 45, not necessarily an바카라 사이트�RPi.听

Your wholesale dealer바카라 사이트檚 licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:听

• category 1.2: without 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in Great Britain or바카라 사이트�EEA바카라 사이트痑nd intended for the UK market

Your licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products not certified under Article 51 of Directive 2001/83/EC听

罢丑别바카라 사이트�current notification of intent to import an unlicensed medicine바카라 사이트痳emains the same.听

Further information on licence categories is available in The Green Guide and Notes for applicants and holders of a wholesale dealer바카라 사이트檚 licence (WDA(H)) or broker registration听

4.听 Procuring human medicines from a country on the list for export purposes听

If you import a medicine from a country on the list to Great Britain, for the purposes of exporting, you will need to hold a wholesale dealer바카라 사이트檚 licence that authorises import activities and export activities. Wholesalers located in Northern Ireland may continue to operate under licences in line with EEA territories and will not require additional licence categories.听

Introduced medicine is a term used to refer to medicines imported for export under category 1.3. A wholesaler could not 바카라 사이트渋mport바카라 사이트� from a third country as that is a manufacturing activity. A wholesaler could, with the correct customs procedures, 바카라 사이트渋ntroduce바카라 사이트� the product for direct supply to a customer in a third country. Further information on licence categories is available in The Green Guide and Notes for applicants and holders of a wholesale dealer바카라 사이트檚 licence (WDA(H)) or broker registration.听

4.1 Importing medicines licensed in the listed country for export听

If the medicine is licensed in the UK or a listed country and intended for import into Great Britain, you will need a RPi.听听

For medicines licensed in the UK, your wholesale dealer바카라 사이트檚 licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:听

• category 1.1: with 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration)

Your licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products certified under Article 51 of Directive 2001/83/EC听

• export听

For medicines licensed in the supplying country with the intent to export these medicines, your wholesale dealer바카라 사이트檚 licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:听

• category 1.3: without 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in the UK and not intended for the UK market

Your licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products certified under Article 51 of Directive 2001/83/EC听

• export听

4.2 Importing medicines not licensed in the listed country or the UK for export听

If the medicine is not the subject of a marketing authorisation in the UK or a listed country then you will need a RP as defined within the Human Medicines Regulations 2012, Regulation 45 and not an RPi to import it into Great Britain for export outside the UK.听

Your wholesale dealer바카라 사이트檚 licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:听

• category 1.3: without 바카라 사이트渁n authorisation바카라 사이트� (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in the UK and not intended for the UK market

Your licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products not certified under Article 51 of Directive 2001/83/EC听

• export听

5. Importing medicines from a country on the list for supply to the United Kingdom parallel import market听

If you import a medicine from a country on the list, for relabelling/repackaging as a parallel import, for supply to the UK parallel import market, you will need to hold a wholesale dealer바카라 사이트檚 licence that authorises import. The imported medicine must have the appropriate marketing authorisation in a country on the list for the designated product licence parallel import (PLPI).听

Your licence will need to cover the following activities and category of handling medicinal products as referred to in section 3.1 above:听

• category 1.4: with a marketing authorisation in바카라 사이트�EEA바카라 사이트痬ember state(s) and intended for the GB parallel import market

Your licence will also need to authorise wholesale distribution operations covering:听

• products imported from countries on a list听

• products certified under Article 51 of Directive 2001/83/EC听

If you are located in GB you will need an RPi. If you are located in Northern Ireland you may import medicines from the EEA without the need for an RPi.听

6. Further information听

For further information, contact our Customer Services Centre at바카라 사이트�info@mhra.gov.uk바카라 사이트痮r call 020 3080 6000.

Alternatively, contact your relevant trade association.听听

Published 31 December 2020

Last updated 30 December 2024 + show all updates

1. 30 December 2024

   Updates to reflect the new UK-wide licensing arrangements for human medicines from 1 January 2025 as part of the Windsor Framework.

2. 22 December 2021

   Update to post-Brexit protocols

3. 31 December 2020

   First published.