Supplying medicines across legal boundaries
Supply of medicines across a legal boundary i.e. from one legal entity to another, is subject to regulatory control. An MHRA Wholesale Dealers Licence (WDL), also termed a Wholesale Dealers Authorisation or Wholesale Dealers Licence for Human Medicines [WDA(H)], is required.
Supplying vaccines within the same organisation
Supply of vaccines from one part of an organisation to another part of the same organisation is not regulated but is subject to organisational controls and must still comply fully with the principles of MHRA Good Distribution Practice and manufacturer’s requirements for safe transport and storage.
Relabelling may be carried out under a WDA(H) if the vaccine is intended for supply to another legal entity
Relabelling (only) to reflect a revised shelf-life as a result of thawing a frozen vaccine may be carried out under a WDA(H) if the vaccine is intended for supply to another legal entity. The WDA(H) requirement is waived under Regulation 19(4A) if supply is under mutual aid or at the direction of NHSEI, to a user at the end of the supply chain. Relabelling may be carried out under S10 or Reg 3A exemption if onward supply is within the same legal entity.
Repacking for supply to another legal entity must be performed under an MHRA Licence (MIA or MS).
Repacking/”packing down” of medicines in bulk for supply to another legal entity is classed as manufacturing (assembly) , is also subject to regulatory control and must be performed under a Manufacturing Licence (MIA) or a Manufacturing (Specials) Licence (MS). Packing a specified number of vials into a cool box in response to daily orders or requisitions from a vaccine site or from a roving vaccination team who then collect and take the vaccine to a care home or school for administration that day, isn’t packing down in regulatory terms but a business-as-usual medicines distribution activity.
Repacking/ “packing down” on a hospital site for supply only within the same legal entity
must be performed under the direct Supervision of a Pharmacist (Sec 10 of the Medicines Act). The MHRA is clear that if this provision is to be used, they expect compliance with principles of Good Manufacturing Practice “in more than name only”. This requires the use of controlled worksheets and labelling systems, SOPs and a pharmaceutical quality management system. Many pharmacy teams would not necessarily have the expertise to meet this requirement.
Packing of a small number of vials for supply from an LVS or VC to a site within a legal entity.
Repacking/”packing down” of a small number of vials for supply from an LVS or VC site to a temporary site (within the same legal entity) must be carried out under Regulation 3A(1) of Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 under the supervision of a doctor, registered nurse or pharmacist. For further information see Transporting Comirnaty Adult and Adolescent from PCN Designated Sites to end user location
AstraZeneca vaccine is currently being used in the NHS under temporary authorisation.
AstraZeneca vaccine is currently being used in the NHS under temporary authorisation under Regulation 174 of the Human Medicines Regulations 2012. In Autumn 2021 it will be available under a Conditional Marketing Authorisation branded as Vaxzevria. Moderna vaccine (branded as Spikevax® from Autumn 2021) is being used under a Conditional Marketing Authorisation. From August 2021 Pfizer vaccine originally authorised under Regulation 174 is being progressively replaced by stock approved under a Conditional Marketing Authorisation and branded as Comirnaty®. Regulation 174 imposes additional regulatory constraints on all aspects of handling relevant vaccines.
When delivered at -20C, Moderna (Spikevax) vaccine needs to be relabelled with a post-thaw expiry date.
The Pfizer vaccine may need to be thawed, packed down and re-labelled with a new post-thaw expiry date. Undiluted Comirnaty® may be moved for a total of no more than 12 hours at 2-8C with no limit on the number of journeys. When delivered at -20C, Moderna vaccine needs to be relabelled with a new post-thaw expiry date. If product is for onward supply to another legal entity this is categorised by MHRA as an assembly activity which needs the agreement of the original manufacturer. This is the model that Alloga and AAH are using for supply of 15-vial packs of thawed vials to PCNs and Community Pharmacy. Very few NHS Trusts hold an MIA and have the facilities / systems to perform repacking under the required cold storage conditions. In August 2021 MHRA has agreed that NHS Organisations with appropriate facilities and capacity can pack down vaccine under an MS Licence.
All COVID-19 vaccines include fragile molecular structures
Senior pharmacists are also reminded that all COVID-19 vaccines include fragile molecular structures which may be damaged if subject to excessive mechanical stress. Every vaccine is therefore, subject to limits on how far and how frequently it can be moved or transported. The limits applying to each vaccine are specified by the manufacturer and are reflected in the conditions of regulatory authorisation.
Vaccines must always be transported in line with their respective Conditions of Authorisation
and in accordance with the Specialist Pharmacy Service SOPs. After first delivery at 2-8C to the NHS by the Specialist Logistics Provider, onward transport should always be kept to an essential minimum and vails should be packed securely to minimise movement and shaking. Thawed Moderna (Spikevax) and thawed Comirnaty vaccine should be moved only in unopened Original Packs because the vials will not be individually labeled with the post-thaw expiry date. Because they are never stored at ULT, AstraZeneca (Vaxzevria) vaccine vials are factory-labeled with the correct expiry date and individual vials may be moved under Mutual Aid provisions if this is deemed essential ( see below)
Moving diluted Comirnaty® vaccine.
The SPC for Comirnaty® permits movement of after dilution for a maximum total of 6 hours but states no limit on the number of journeys allowed. The inherent fragility of the vaccine molecule remains unchanged. The aim should therefore still be to limit movements to an essential minimum. Since dilution necessitates puncture of the vial, transport at 2-8C using a cool box is recommended to limit the risk of microbial proliferation if contamination occurs during dilution.
Moving punctured vials of any vaccine
If it is essential to transport a vial of any vaccine after first puncture, it should be in a cool box at 2-8C and the vial must be used within 6 hours of first puncture. If a vaccinator has in their possession punctured and unpunctured vials, it is essential they are stored and transported separately to avoid the risk of confusion.
Moving thawed Moderna (Spikevax) vials
Since relevant data was submitted to MHRA, Moderna (Spikevax) vials may be transported at 2-8C for a maximum cumulative journey time of 12 hours without limit on the number of journeys.
Mutual aid is allowed under Regulation 19(4A) of the HMR 2012
Mutual aid is allowed under Regulation 19(4A) of the HMR 2012 amended (The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 Statutory Instruments 2020 No.1125) to provide additional exemptions from the requirement to hold a wholesale dealer’s licence, where a medicine is to be used for vaccination against coronavirus or flu. This allows a person to supply without a WDL if:
- They had been supplied the vaccine under the relevant arrangements, and
- They supply it directly to the vaccinator to administer or to the organisation the vaccinator works for, under relevant arrangements.
Under Mutual, Aid, Pfizer (Comirnaty) and Moderna (Spikevax) vaccines should be moved in Original Packs labeled with the post-thaw expiry date at 2-8C. Because they are never stored at ULT, AstraZeneca (Vaxzevria) vaccine vials are factory-labeled with the correct expiry date and individual vials may be moved under Mutual Aid provisions if this is deemed essential (see below)
Exemption provided by Regulation 19(4A) applies specifically to supply in extremis
The exemption provided by Regulation 19(4A) applies specifically to supply in extremis, for immediate use in circumstances where vaccine would otherwise be unavailable to patients. The regulatory flexibilities which allow for mutual aid, DO NOT exempt (packing down or) routine supply across legal boundaries under any other circumstances. Mutual aid is designed specifically and exclusively to allow an immediate patient need to be met in exceptional cases only, where planned supplies cannot, or if waste of viable vaccine can be avoided in no other way. No site may order vaccine with the specific intent of onward supply as mutual aid.
Other existing flexibilities or exemptions
Other existing flexibilities or exemptions used by NHS Specials units for repackaging and supply within the NHS cannot be used.
Mutual aid is defined in NHSEI policy as the transfer of COVID-19 vaccine by one organisation or provider providing NHS COVID-19 vaccination services to another. For example, where, in extremis, a Hospital Hub transfers vaccine to a Local Vaccination Service; or where one Local Vaccination Service PCN grouping transfers vaccine to another PCN grouping or a local hospital to meet an immediate patient need. See NHSEI Mutual Aid policy
- Heading changed: Relabelling for supply to another legal entity must be carried out under an MIA or MS
- Amendment: The WDA(H) requirement is waived under Regulation 19(4A) if supply is under mutual aid..... OR AT THE DIRECTION OF NHSEI..... to a user at the end of the supply chain.
- Link to NHSEI Mutual Aid Policy updated
- major revision to clarify MHRA licence requirements for packing and labelling for supply across legal boundaries, to add brand names, reflect provision to allow Moderna to be moved at 2-8C, and to clarify that opened packs of AZ ONLY may be moved under MA.
- minor typo corrected
- Typo corrected
- Updated to correct typos, rearrange paragraphs and reflect the imminent arrival of Comirnaty and Spikevax branded products
- "Re-labeling" changed to "re-labelling" throughout, in response to user feedback !
- typo correction x 1. Addition of "for 15-vials packs" to para on WDAH supply of Pfizer vaccine.