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 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.
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. Moderna vaccine (to be branded as Spikevax® in Autumn 2021) is being used under a Conditional Marketing Authorisation. From August 2021 Pfizer vaccine originally authorised under Regulation 174 will progressively be 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.
Repacking for supply to another legal entity must be performed under a Manufacturing Licence (MIA).
Repacking/”packing down” of medicines 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)
When delivered at -20C, Moderna 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. From August 2021 MHRA has agreed that NHS Organisations with appropriate facilities and capacity can pack down vaccine under an MS Licence.
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 coolbox is recommended to limit the risk of microbial proliferation if contamination occurs during dilution.
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 COVID-19 Vaccine Pfizer-BioNTech from Designated Sites to end user location – SPS – Specialist Pharmacy Service – The first stop for professional medicines advice
Limited quantities of vaccines may be supplied by a legal entity without a WDL to another using strict criteria
In extremis, in the absence of any other means of timely supply, limited quantities of vaccines needed to meet immediate needs of patients may be supplied by a legal entity which does not hold a WDL to another using the strict criteria set out in the NHSEI Mutual Aid policy
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.
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
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.
NHSEI and MHRA are aware of information from the US Centre for Disease Control
NHSEI and MHRA are aware of information from the US Centre for Disease Control which permits transport of Moderna COVID-19 vaccine vials and syringes at 2-8C with a maximum allowed total transit time of 12 hours without limit on the number of journeys. Moderna has not so far submitted to the MHRA as part of its licence application data that would support issue of similar guidance the NHS. Furthermore, Information supplied directly by Moderna to EU government agencies, Ministries of Health and Distributers stipulates that their vaccine should not be moved more than once at 2-8C. This journey has already been used by PHE to deliver the vaccine to NHS vaccination sites other than VCs. Advice to the NHS remains that Moderna vaccine should not be moved again after delivery at 2-8C. If further data is submitted to the MHRA current guidance will be reviewed. Differences of this sort between national medicinal product approvals are not uncommon and can be due to variety of causes such as differences in manufacturing processes and/or raw materials. What can be supported in one country cannot be assumed to be applicable to others.
- minor typo corrected
- Typo corrected
- Updated to correct typos, rearrange paragraphs and reflect the imminent arrival of Comirnaty and Spikevax branded products
- typo correction x 1. Addition of "for 15-vials packs" to para on WDAH supply of Pfizer vaccine.
- "Re-labeling" changed to "re-labelling" throughout, in response to user feedback !