Importing Medicines to GB 2021 UK Guidance

by
MedicinesUK Post-Exit Guidance Notes [2020]
Guidance

Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021

The actions to take for sourcing medicines in different circumstances.

Published 1 September 2020
Last updated 20 October 2020 — see all updates
From:
Medicines and Healthcare products Regulatory Agency

New rules for January 2021

The UK has left the EU, and the transition period after Brexit comes to an end this year.

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.

For current information, read: Good manufacturing practice and good distribution practice

You can also read about the transition period.

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

From 1 January 2021, Qualified Person (QP) certified medicines from the European Economic Area (EEA) will be 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 will remain in force from 1 January 2021

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

The licence granted to a wholesaler in Great Britain will permit the importation of medicinal products from a country which is on an approved country for import list (initially, this will be countries in the European Economic Area (EEA)) if you undertook this activity before 1 January 2021 and take the following actions:

  • within 6 months from 1 January 2021, notify MHRA in writing of your intention to continue to import medicinal products from a country on the list
  • within 2 years from 1 January 2021, nominate and have named on your wholesale dealer’s licence a Responsible Person (import) (RPi) who will carry out specific functions

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 as an introduced medicine. This is because of an exemption in relation to the need for an RPi.

In this case you must, within 6 months from 1 January 2021, notify MHRA in writing of your intention to only import medicinal products from the listed country, to which this exemption applies.

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.

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. 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 wish to import a licensed medicine from a listed country.

Further information on a country on the list

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

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 or Great Britain 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 or Great Britain Marketing Authorisation, certificate of registration or traditional herbal registration) in Great Britain and intended for the Great Britain 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 or GB Marketing Authorisation, certificate of registration or traditional herbal registration) in Great Britain and intended for the Great Britain 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 as an introduced medicine

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

4.1 Importing medicines licensed in the listed country as an introduced medicine

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

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

  • 1.1 With “an authorisation” (a UK or Great Britain 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

4.2 Importing medicines not licensed in the listed country or the UK for export as an introduced medicine

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 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.

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

If you import a medicine from a country on the list, for supply to the Great Britain 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 designed Great Britain 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

Rules for importing medicines to Northern Ireland are different because of the Northern Ireland Protocol. Further guidance will be published in due course.

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 to a third country, 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:

Published 1 September 2020
Last updated 20 October 2020