Medicines Healthcare Products Regulatory Agency
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1. Overview
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.
2. Importing authorised medicines into the UK from a source which is on the approved country for import list
The Human Medicines Regulations 2012 refers to a list of approved countries for importing medicines under a wholesale dealers licence. The UK accepts qualified person (QP) certification from the countries on the list. See further information on the approved country list.
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 on?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.
If you hold a wholesale dealers licence for such purposes it remains in force.
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.
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:
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products imported from countries on a list
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products certified under Article 51 of Directive 2001/83/EC
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a named RPi who will carry out specific functions
2.1 Wholesale dealer licence categories related to the authorisation status of medicinal products???
???There are several wholesale dealer licence categories that you can apply for. These include:???
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???category 1.1: with an authorisation (a UK, Great Britain or Northern Ireland marketing authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)??
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???category 1.2: 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 Great Britain and intended for the UK market
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???category 1.3: 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
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???category 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.
An?EEA?manufacturer 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.
3. Importing human medicines from a country on the list for use as a special medicinal product
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 dealers licence that authorises import.
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.
3.1 Importing medicines licensed in the listed country into Great Britain as unlicensed medicines
If you are importing a medicine that is licensed in the listed country, you will need an RPi.
Your wholesale dealers licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:
- category 1.2: without an authorisation (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in Great Britain or?EEA?and intended for the UK market
This licence will also need to authorise wholesale distribution operations covering:
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products imported from countries on a list
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products certified under Article 51 of Directive 2001/83/EC
The?current notification of intent to import an unlicensed medicine?remains the same.
Further information on licence categories is available in The Green Guide and Notes for applicants and holders of a Wholesale Dealers Licence (WDA(H)) or Broker Registration.
3.2 Importing medicines not licensed in the listed country
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 an?RPi.
Your wholesale dealers licence will need to cover the following category of handling medicinal products as referred to in section 3.1 above:
- category 1.2: without an authorisation (a UK, Great Britain or Northern Ireland marketing authorisation, certificate of registration or traditional herbal registration) in Great Britain or?EEA?and intended for the UK market
Your licence will also need to authorise wholesale distribution operations covering:
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products imported from countries on a list
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products not certified under Article 51 of Directive 2001/83/EC
The?current notification of intent to import an unlicensed medicine?remains the same.
Further information on licence categories is available in The Green Guide and Notes for applicants and holders of a wholesale dealers licence (WDA(H)) or broker registration
4. Procuring human medicines from a country on the list for export purposes
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 dealers licence that authorises import activities and export activities. Wholesalers located in Northern Ireland may continue to operate under licences in line wi