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As the regulatory landscape continues to evolve post-Brexit, importing medicines into Great Britain from European Economic Area (EEA) states on the approved country list has its own set of requirements. To ensure compliance with UK regulations, companies importing medicines must follow specific guidelines outlined by the Medicines and Healthcare products Regulatory Agency (MHRA). In this blog, we will walk through the key steps and requirements for importing medicines from approved countries and the roles of Responsible Persons (RPs) and Responsible Persons for Import (RPis).
1. Importing Medicines from the EEA: Key Requirements:
Medicines certified by a Qualified Person (QP) in the European Economic Area (EEA) are accepted in Great Britain (England, Wales, and Scotland) provided certain checks are met. These checks are described in the MHRA’s guidance on the responsibilities of wholesale dealers.
Importantly, QP-certified medicines from the EEA will not need re-testing or re-certification by a UK QP if the importing and checking processes are handled by a licensed wholesale dealer in Great Britain.
If you already hold a wholesale dealer’s licence, this licence remains valid, but there are some key steps to ensure continued compliance when importing medicinal products from countries on the approved list.
1.1. Steps to Permit Importation from Approved Countries:
To import medicines from countries on the approved list, you must:
Apply for a variation to your wholesale dealer’s licence to include products imported from the approved countries.
Ensure the imported products are certified under Article 51 of Directive 2001/83/EC.
Nominate a Responsible Person for Import (RPi) to carry out specific duties related to imported medicinal products.
For those licence holders who notified their intention to continue importation by the June 30, 2021 deadline, there is a grace period until December 31, 2022, to nominate an RPi.
Note: If the imported medicine is not licensed in the UK or the approved country and is being imported as a “special” or for export, an RPi is not required.
2. Importing UK or GB-Authorised Medicines from Approved Countries
If you are importing UK or Great Britain authorised medicines from a country on the approved list, your wholesale dealer’s licence must be extended to cover these imports.
Your licence must cover activities that involve:
The importation of products certified under Article 51 of Directive 2001/83/EC.
Handling of medicinal products with a valid UK, Great Britain, or Northern Ireland marketing authorisation (MA).
You will also need to nominate an RPi to oversee these operations and ensure compliance with UK import regulations.
3. Importing Special Medicinal Products:
For medicines imported as special medicinal products, which are typically unlicensed medicines required for specific patient needs, the process varies depending on the medicine's licence status in the listed country:
If the medicine is licensed in the listed country, an RPi is required.
If the medicine is not licensed in the listed country, you will need an ordinary Responsible Person (RP) to handle the importation.
Your licence must cover handling medicinal products from countries on the list, whether or not they are certified under Article 51 of Directive 2001/83/EC.
4. Importing Medicines for Export:
When importing medicines with the intention of exporting them outside the UK, specific guidelines apply:
If the medicine is licensed in the UK or a listed country, you will need an RPi to manage the importation and export process.
For medicines not licensed in the UK or the listed country, an RP will oversee the import/export activity.
In either case, your wholesale dealer’s licence must authorise both the import and export of medicinal products, certified under Article 51 of Directive 2001/83/EC, where applicable.
5. Parallel Importing of Medicines:
Parallel importing refers to importing a medicine from an approved country to be re-labelled or re-packaged for the UK market. To import for parallel trade, your wholesale dealer’s licence must authorise the import of medicinal products with a marketing authorisation in EEA member states.
For supply to the UK Parallel Import (PLPI) market, the licence must cover:
Products certified under Article 51 of Directive 2001/83/EC.
Activities related to the importation of licensed medicines, and re-packaging/re-labelling.
An RPi will be required to ensure that the product complies with UK regulations before it is supplied to the UK market.
6. Importing Medicines from Northern Ireland to Great Britain:
Medicinal products sourced from Northern Ireland can be imported into Great Britain under specific conditions:
For wholesale purposes, an RP (not an RPi) is required to supervise the activity.
Medicines authorised under the Unfettered Access scheme, which grants automatic authorisation in Great Britain for Northern Ireland-licensed products, must display the (UA) suffix on their packaging. These products can only be sourced from a Northern Ireland manufacturer or wholesaler.
Additionally, for sourcing biological medicines, a national batch release certificate from the National Institute for Biological Standards and Control (NIBSC) must be obtained for each batch.
Conclusion:
Importing medicines into Great Britain from an EEA state or another country on the approved import list requires careful adherence to MHRA guidelines. Key steps include ensuring the necessary variations to your wholesale dealer’s licence, nominating a Responsible Person for Import (RPi), and validating that imported products are certified in line with regulatory standards. Whether importing for the UK market or export, compliance with these requirements is crucial for maintaining product quality and meeting legal obligations.
At PharmaGXP Services Limited, we can support you through the complex regulatory landscape, ensuring your importation processes align with UK guidelines and best practices. Contact us to learn more about how we can assist in managing your importation needs efficiently and compliantly.
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