* Medicines & Healthcare products Regulatory Agency Guidance ACTING AS A RESPONSIBLE PERSON (IMPORT) AFTER BREXIT Updated 9 October 2019 THIS GUIDANCE WAS WITHDRAWN ON 24 FEBRUARY 2020

For current information see Good manufacturing practice and good distribution practice CONTENTS * 1. Introduction * 2. What evidence can be used for QP certification * 3. Additional guidance

* 4. Products not covered by the WDA(H) importation model * 5. Working as a Responsible Person (import) * 6. Becoming a Responsible Person (Import). Print this page © Crown copyright 2019

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit

https://www.gov.uk/government/publications/importing-medicines-from-an-eea-state-which-is-on-an-approved-country-for-import-list/guidance-for-the-role-of-the-responsible-person-import If

there is a no-deal Brexit, a wholesale dealer may import Qualified Person (QP) certified medicines form the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person

(import) (RPi)’. This guidance describes how you can apply to be a RPi, and how to verify that QP certification has been done in the EEA. RPi applications may be submitted through the MHRA

Portal after the UK leaves the EU. 1. INTRODUCTION The RPi is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been

imported into the UK from countries on a list (initially, this will be countries in the EEA). The RPi may delegate the activity of checking QP 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 has taken place when importing into the UK the following

products from a listed country: * A UK licensed medicine for use in the UK * A UK licensed medicine as an introduced medicine for supply to another third country * An EEA licensed medicine

- supply to fulfil special clinical needs * An EEA licensed medicine imported as an introduced medicine for supply to another third country * An EEA licensed medicine for use as starting

material for 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

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. Other evidence may be acceptable provided it confirms that QP certification has

taken place for the batch in question. 2.1 EVIDENCE FOR UK WHOLESALE DEALERS LICENCE (WDA(H)) HOLDERS IMPORTING A UK OR EEA LICENCED MEDICINE FROM A LISTED COUNTRY Batch certification by a

Qualified Person 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 licenced 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. ADDITIONAL GUIDANCE 3.1 SUPPLY CHAIN SECURITY

Checks on product 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 guidance. Products that have been certified by a QP but have been diverted to countries not within a listed country must be imported by the holder of an MIA and

recertified by a QP. 3.2 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: * as starting material for parallel import * for use for special clinical need or introduction This is required by the EU’s Falsified

Medicine Directive Products that are supplied as decommissioned must be decommissioned by the final EEA supplier and not at any other point in the supply chain. 3.3 UK WDA(H) HOLDERS ACTING

AS OR ON BEHALF OF THE UK MARKETING AUTHORISATION HOLDER (MAH) For UK WDA(H) holders acting as or on behalf of the UK MAH, the expectation is that products have been certified prior to

importation. Shipment to the UK under pre-certification quarantine is not acceptable for the WDA(H) importation model. 4. PRODUCTS NOT COVERED BY THE WDA(H) IMPORTATION MODEL Products with a

UK marketing authorisation and imported into the UK without EEA QP certification are out of scope of this guidance. A UK MIA and QP certification is required before placing the product on

the market. Products without a marketing authorisation in the UK or EEA are outside the scope of this guidance. Importation is permitted under the supervision of a Responsible Person (RP),

with notification of each importation to the MHRA. Products without a marketing authorisation in a listed country for supply as introduced product to another third country are outside the

scope of this guidance. Importation is permitted under the supervision of a Responsible Person (RP). 5. WORKING AS A RESPONSIBLE PERSON (IMPORT) If you are named as a RPi on a wholesale

distribution authorisation (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 certified by a Qualified Person prior to being placed

on the UK 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 A RESPONSIBLE PERSON (IMPORT). There are two stages to becoming named as a Responsible Person (Import) 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 a Responsible Person (import). 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 [email protected]. 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 wholesale dealers licence. 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 [email protected]. 6.1.3.

QUALIFIED PERSONS ACTING AS RESPONSIBLE PERSON (IMPORT) If you are a person named on the Qualified Persons register you will also be eligible to act as a 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 A RESPONSIBLE PERSON (IMPORT) RPi applications may be submitted through the

MHRA Portal after the UK leaves the EU. The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended). This guidance

will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. Back to top