Guidance

Importing medicines on an approved country for import list in a no-deal Brexit

Updated 9 October 2019

This guidance was withdrawn on 24 February 2020

For current information see Good manufacturing practice and good distribution practice

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

If you hold a wholesale dealer’s licence on the day the UK leaves the EU it will remain in force after exit day.

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

This licence will also 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 exit day and take the following actions:

• within 6 months from exit day, notify MHRA in writing of your intention to continue to import medicinal products from a country on the list
• within 2 years from exit day, 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 a RPi if the medicine imported from the listed country is not licenced in 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 a RPi.

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

If you do not hold a wholesale dealer’s licence before the UK leaves the European Union, in order to wholesale deal medicine you will need to apply for a wholesale dealer’ licence. The requirement to name a RPi on the wholesale dealer’s licence will apply immediately to all new licence applications made after exit day if you wish to import a licensed medicine from the listed country.

Further information on a country on the list.

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

If you import a UK 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 Marketing Authorisation, certificate of registration or traditional herbal registration)

Your licence must authorise wholesale distribution operations, including:

• 2.5 Products imported from countries on a list,
• 2.5a 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 in the UK, 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 a RPi.

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

• 1.2 Without “an authorisation” (a UK Marketing Authorisation, certificate of registration or traditional herbal registration) in the UK and intended for the UK market

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

• 2.5 Products imported from countries on a list

• 2.5a 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 listed country, you will need an ordinary Responsible Person and not a RPI.

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

• 1.2 Without “an authorisation” (a UK Marketing Authorisation, certificate of registration or traditional herbal registration) in the UK and intended for the UK market

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

• 2.5 Products imported from countries on a list

• 2.5b 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 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

• 1.2 Without “an authorisation” (a UK Marketing Authorisation, certificate of registration or traditional herbal registration) in the UK and intended for the UK market

Your licence will also need to authorise wholesale distribution operations covering

• 2.5 Products imported from countries on a list,
• 2.5a Products certified under Article 51 of Directive 2001/83/EC.

4.2 Importing medicines not licensed in the listed country as an introduced medicine

If the medicine is not the subject of a marketing authorisation you will need an ordinary Responsible Person and not a RPi.

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

• 1.2 Without “an authorisation” (a UK Marketing Authorisation, certificate of registration or traditional herbal registration) in the UK and intended for the UK market.

Your licence will also need to authorise wholesale distribution operations covering

• 2.5 Products imported from countries on a list,
• 2.5b Products not certified under Article 51 of Directive 2001/83/EC.

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

If you import a medicine from a country on the list, 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 designed UK 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 UK parallel import market

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

• 2.5 Products imported from countries on a list
• 2.5a Products certified under Article 51 of Directive 2001/83/EC

You will need a RPi.