From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’. Great Britain is England, Wales and Scotland.

This guidance describes:

• how you can apply to be an RPi,
• how to verify that QP certification of a medicine has been done in the EEA
• how to verify that biological products (vaccines and medicines derived from human blood or plasma) have an independent batch release certificate

RPi applications may be submitted through the MHRA Portal from 1 January 2021.

Products which do not require RPi oversight

Medicinal products sourced from Northern Ireland for wholesale purposes are out of scope of this guidance. This is permitted under the supervision of a Responsible Person (RP).

Products with a UK or Great Britain marketing authorisation that are imported into Great Britain from outside the UK without QP certification from a country on the list will require QP certification under a UK manufacturing and import authorisation before being placed on the market.

Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance. Importation of such products is permitted under the supervision of a Responsible Person (RP), with notification to the MHRA of each importation that is for supply to the Great Britain market.

1. Introduction

The RPi is responsible for implementing a system to confirm for products that have been imported into Great Britain from countries on an approved country for import list (initially, this will be countries in the EEA):

• that the required QP certification has taken place
• that the required independent batch release certificate is available for biological products (described on a wholesale dealer’s license as ‘immunologicals and blood products’)

The RPi may delegate the activity of checking this certification has taken place but remains responsible for ensuring the effectiveness of these checks.

The RPi is required to implement a system for confirming QP certification and independent batch release certification (for biological products) has taken place when importing into Great Britain the following products from a listed country:

• A UK or Great Britain licensed medicine for use in Great Britain
• A UK or Great Britain licensed medicine for supply to another third country
• A Northern Ireland or approved country licensed medicine for supply to fulfil special clinical needs
• A Northern Ireland or approved country licensed medicine imported as an introduced medicine for supply to another third country
• A Northern Ireland or approved country licensed medicine for use as a parallel import

2. What evidence can be used for QP certification

The RPi should ensure that written evidence is available to demonstrate that each batch of product has been QP certified as required in Article 51 of Directive 2001/83/EC.

Not all options listed below may be suitable for different supply chain relationships, however just one of these pieces of evidence is sufficient to satisfy the requirements of regulation 45AA of the Human Medicines Regulations 2012. Other evidence may be acceptable provided it confirms that QP certification has taken place for the batch in question.

2.1 Evidence for Great Britain Wholesale Dealers Licence (WDA(H)) holders importing a UK, Northern Ireland, Great Britain or EEA licensed medicine from a listed country

Batch certification by a QP may be confirmed using evidence such as:

• Batch certificate confirming QP certification in accordance with Article 51 of Directive 2001/83/EC)
• A copy of the ‘control report’ (Appendix II to EU Good Manufacturing Practice Annex 16)
• Statement of certification (ad-hoc, confirming certification in accordance with Article 51 of Directive 2001/83/EC)
• Reference to company internal systems (e.g. global Enterprise Resource Planning system) that shows batch certification
• Confirmation that the final manufacturing step (other than batch certification) of an authorised medicine has been performed by a Manufacturing and Import Authorisation holder in a listed country. A copy of the Marketing Authorisation and technical agreement with the manufacturer should be available to place reliance on this supply chain control
• For medicines authorised in a listed country, batch certification may be verified by confirming that the medicine has been purchased from an authorised wholesaler after it has been ‘placed on the market’ in the listed country

3. What evidence can be used for independent batch release certification

Biological products requiring independent batch release certification are listed on the European Directorate for Quality of Medicines website.

Independent batch release may be confirmed using evidence such as:

• a statement from the marketing authorisation holder confirming that a batch certificate has been issued by NIBSC or a Mutual Recognition Agreement partner
• a copy of the batch certificate issued by NIBSC or a Mutual Recognition Agreement partner
• confirmation from NIBSC that a batch certificate has been issued. Enquiries should be sent to CPB@nibsc.org.

Batches of QP certified biological medicines that require independent batch release should not be sold or supplied by the importing wholesale dealer in Great Britain until independent batch release certification is also confirmed.

4. Additional guidance

4.1 Supply chain security

Checks on products imported from a listed country should also ensure that the product is not the subject of a recall or reported as stolen and is available on the market within the listed country’s licensed supply chain. Good Distribution Practice (GDP) requirements for supplier qualification set out in GDP 5.2 must be maintained. The MHRA’s supplier verification blog provides additional information. Products that have been certified by a QP but have been diverted to countries not within a listed country or Northern Ireland must be imported by the holder of an MIA and recertified by a QP.

4.2 Products imported for parallel import or special need

The RPi should implement a process to confirm the status of the unique identifier for Prescription Only Medicines, if wholesale dealers are importing products:

• for parallel import
• for use for special clinical need or introduction

This is required by the EU’s Falsified Medicine Directive. Confirmation of decommissioning may be provided by using evidence such as National Medicines Verification System records from the supplier.

Products that are supplied as decommissioned must be decommissioned by the final EEA supplier and not at any other point in the supply chain.

4.3 Great Britain WDA(H) holders acting as or on behalf of the UK Marketing Authorisation Holder (MAH)

For Great Britain WDA(H) holders acting as or on behalf of the UK or Great Britain MAH, the expectation is that products have been certified prior to importation. Shipment to Great Britain under pre-certification quarantine is not acceptable for the WDA(H) importation model.

If supply chains require shipment under quarantine prior to QP certification for technical reasons (e.g. products with very short shelf life) the MAH should seek further advice from MHRA by email to GDP.Inspectorate@mhra.gov.uk.

5. Working as an RPi

If you are named as an RPi on a WDA(H) you have an important role in ensuring the safe control of medicines. You have training and an understanding of the industry in order to qualify for the role, where you have the legal responsibility to ensure that batches of authorised medicines imported from countries on a list have been appropriately certified prior to being placed on the Great Britain market.

You will take responsibility for implementing a system for the WDA(H) as a whole. There is no requirement for each site on the WDA(H) to name its own RPi. You do not have to be an employee of the licence holder but must be continuously contactable. Where you are not an employee, there should be a written contract between the licence holder and the RPi specifying responsibilities, duties, authority and time on site.

If you are a contract RPi then you are expected to ensure you do not over-extend yourself and apply to act as RPi for too many companies.

6. Becoming an RPi

There are two stages to becoming named as an RPi.

6.1 Eligibility

You must first demonstrate that you are eligible to act as an RPi. This is through a combination of relevant qualifications and experience. It is also expected that you will be a member of a professional body with a published code of conduct. Once eligibility has been assessed and accepted by MHRA, you can be named on a register; the register will be maintained by MHRA and will include all persons eligible to be named as an RPi.

The regulations set out expectations for qualifications, experience and membership of professional bodies.

Qualifications

Acceptable qualifications are a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in:

• pharmacy
• chemistry
• medicine
• biology or
• a related life science

Equivalent qualifications acceptable for RPi candidates include:

• Level 5 qualifications from Chartered Institute of Logistics and Transport
• A Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor qualification awarded by Chartered Quality Institute

Other qualifications may also be acceptable. These will be checked during the application process. You can check the suitability of your qualifications by email to GDP.Inspectorate@mhra.gov.uk.

6.1.1. Experience

You must be able to demonstrate, for example by providing a curriculum vitae (CV), that you have a minimum of 2 years’ experience in performing the functions of a responsible person on a WDA(H). Evidence of performing other functions, for example a quality assurance role for a pharmaceutical manufacturer, may also be considered equivalent.

6.1.2. Professional bodies

Acceptable professional body memberships are:

• Royal Society of Biology
• Royal Pharmaceutical Society
• Pharmaceutical Society of Northern Ireland
• Royal Society of Chemistry

Additional bodies that the licensing authority considers to be equivalent for RPi candidates include:

• The Chartered Institute of Logistics and Transport
• The Chartered Quality Institute.

Other professional associations may be acceptable. These will be checked during the application process. You can check the suitability of your professional body membership by email to GDP.Inspectorate@mhra.gov.uk.

6.1.3. Qualified Persons acting as RPi

If you are a person named on the Qualified Persons register you will also be eligible to act as an RPi. You must still apply to be named on the RPi register. As an alternative to providing evidence of your qualifications and membership of a professional body you may provide evidence of your QP registration.

6.2 Suitability

You must also demonstrate suitability to be named on a specific WDA(H) licence. At the time of application, MHRA will confirm whether you are named on the register, and check whether your experience is suitable for the proposed licence activity. For example, an eligible RPi without prior experience in parallel importation might not be considered suitable to be named on WDA(H) where the company are importing licensed products for parallel trade.

6.3 Applying to be named as an RPi

RPi applications may be submitted through the MHRA Portal from 1 January 2021.

The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended).

The RPi should be a UK resident. You will need to provide proof of address and identity when you apply.

This guidance will apply 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:

• Association of British HealthTech Industries (ABHI): phil.brown@abhi.org.uk
• Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
• British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
• BioIndustry Association (BIA): regulatory@bioindustry.org
• Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
• Ethical Medicines Industry Group (EMIG): info@emig.org.uk
• Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
• The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk