Guidance

Sourcing medicines for the UK Market

The actions to take for sourcing medicines in different circumstances.

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020
Last updated
22 December 2021 — See all updates

1. Importing medicines from an EEA State which is on an approved country for import list

Qualified Person (QP) certified medicines from the European Economic Area (EEA) are 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 Qualified Person (QP) if imported and checked by a wholesale dealer in Great Britain.

If you hold a wholesale dealer’s licence it remains in force.

1.1 Actions to take so your licence can permit the importation of medicinal products from a country which is on an approved country for import list

You need to apply for a variation to add to your licence:

  • products imported from countries on a list
  • products certified under Article 51 of Directive 2001/83/EC
  • and nominate a Responsible Person (import) (RPi) who will carry out specific functions

Licence holders who notified their intention to continue importation of medicinal products from approved countries for import by 30 June 2021 have until 31 December 2022 to nominate an RPi.

You do not need an RPi if the medicine imported from the listed country is not licenced 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.

An EEA manufacturer or wholesaler may only supply a licensed medicine to a wholesaler in Great Britain. The sale and supply to an authorised person (hospital, doctor or retailer) must be from a UK licensed wholesaler.

Further information on a county on the list

2. Importing UK or Great Britain authorised human medicines from a country on the list

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.

This licence will need to cover the following activities of handling medicinal products:

  • 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, certificate of registration or traditional herbal registration).

Your licence must authorise wholesale distribution operations, including:

  • Products imported from countries on a list
  • Products certified under Article 51 of Directive 2001/83/EC

You will need a Responsible Person (import).

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

If you import a medicine from a country on the list, for use as a special medicinal product, you will need to hold a wholesale dealer’s licence that authorises import.

3.1 Importing medicines licensed in the listed country

If the medicine is licensed in the listed country, you will need an RPi.

Your wholesale dealer’s licence will need to cover the following activities of handling medicinal products:

  • 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:

  • Products imported from countries on a list
  • Products certified under Article 51 of Directive 2001/83/EC

The current notification of intent to import an unlicensed medicine remains the same.

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 an ordinary Responsible Person and not an RPI.

Your wholesale dealer’s licence will need to cover the following activities of handling medicinal products.

  • 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:

  • Products imported from countries on a list
  • Products not certified under Article 51 of Directive 2001/83/EC

The current notification of intent to import an unlicensed medicine remains the same.

4. Importing human medicines from a country on the list for export

If you import a medicine from a country on the list, that you will export, you will need to hold a wholesale dealer’s licence that authorises import and export.

Introduced medicine is a term used previously for the category 1.3. To be clear, a wholesaler could not “import” from a third country as that is a manufacturing activity. A wholesaler could, with the correct customs procedures, “introduce” the product for direct supply to a customer in a third country.

4.1 Importing medicines licensed in the listed country

If the medicine is licensed in the UK or a listed country, you will need a Responsible Person (import).

For medicines licensed in the UK: your wholesale dealer’s licence will need to cover the following activities of handling medicinal products:

  • 1.1 With “an authorisation” (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:

  • Products imported from countries on a list
  • Products certified under Article 51 of Directive 2001/83/EC
  • Export

For medicines licensed in a listed country: your wholesale dealer’s licence will need to cover the following activities of handling medicinal products:

  • 1.3 Without “an authorisation” (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:

  • Products imported from countries on a list
  • Products certified under Article 51 of Directive 2001/83/EC
  • Export

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

If the medicine is not the subject of a marketing authorisation in the UK or a listed country then you will need an ordinary Responsible Person and not an RPi to import it into Great Britain for export outside the UK.

Your wholesale dealer’s licence will need to cover the following activities of handling medicinal products.

  • 1.3 Without “an authorisation” (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.

Without “an authorisation” (a UK or Great Britain 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:

  • Products imported from countries on a list
  • Products not certified under Article 51 of Directive 2001/83/EC
  • Export

5. Importing medicines from a country on the list for supply to the United Kingdom Parallel Import market

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 dealer’s 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).

Your licence will need to cover the following activities of handling medicinal products:

  • 1.4 With a Marketing Authorisation in EEA member state(s) and intended for the GB parallel import market Your licence will also need to authorise wholesale distribution operations covering:
  • Products imported from countries on a list
  • Products certified under Article 51 of Directive 2001/83/EC

You will need an RPi if located in Great Britain.

6. Sourcing a medicine from Northern Ireland to Great Britain

6.1 Sourcing for wholesale

Medicinal products sourced from Northern Ireland for wholesale purposes are permitted under the supervision of an ordinary Responsible Person (RP) and not an RPi.

If you hold a WDA with sites in Northern Ireland and Great Britain, an RPi will be required for activities conducted in Great Britain.

6.2 Products granted an authorisation under the Unfettered Access scheme

To facilitate unfettered access for Northern Ireland products to the Great Britain market, medicines authorised within Northern Ireland will be granted an authorisation in Great Britain. The 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.

6.3 Sourcing for parallel trade 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, you will need a wholesale dealer’s licence. You will need an ordinary Responsible Person and not an RPi.

6.4 Sourcing biological medicines

A Northern Ireland manufacturer or wholesaler who supplies a biological medicines to Great Britain will need to confirm that a national batch release certificate has been issued by NIBSC for each batch.

Further advice on independent batch release in the United Kingdom from 1 January 2021.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Updates to this page

Published 31 December 2020
Last updated 22 December 2021 + show all updates

  1. Update to post-Brexit protocols

  2. First published.

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