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This publication is available at 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
In the event of the UK leaving the EU without a deal, 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.
The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended). The draft legislation that inserts these regulations in to the HMRs is live: it has not yet been approved by the Houses of Parliament.
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. Acceptable evidence of 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 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
If wholesale dealers import products as starting material for parallel import, use for special clinical need or introduction the RPi should implement a process to confirm the status of the unique identifier for Prescription Only Medicines, (specifying who decommissioned the packs and when this was done) as 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)
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.
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
- biology or
- a related life science
Equivalent qualifications acceptable for RPi candidates include
- Level 5 qualifications from Chartered Institute of Logistics and Transport
- 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.
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 GDP.Inspectorate@mhra.gov.uk.
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.
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.