Supply 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 usually required. Supply must also be in accordance with NHSE guidance.
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.
Relabelling may be carried out under Section 10 exemption from the Medicines Act 1968 or Reg 3A exemption from the Human Medicines Regulations 2012 if onward supply is within the same legal entity.
Repacking, or ”packing down”, of medicines in bulk for supply to another legal entity is classed as manufacturing (assembly). This is also subject to regulatory control and must be performed under a Manufacturing Licence (MIA) or a Manufacturing (Specials) Licence (MS).
Supply 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. It must still comply fully with the principles of MHRA Good Distribution Practice and the vaccine manufacturer’s requirements for safe transport and storage. Supply must also be in accordance with NHSE guidance.
Repacking on a hospital site
The activity of repacking, or “packing down” must be performed under the direct Supervision of a Pharmacist (Section 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 will not necessarily have the expertise to meet this requirement.
Packing vials on a vaccination site
It should be noted that packing a number of individual vials into a cool box isn’t a licensable activity in regulatory terms, but business-as-usual medicines distribution when performed in response to daily orders or requisitions from another site within the same legal entity, or from a roving vaccination team who then collect and take the vaccine to a care home or school for administration that day.
Packing a specified number of vials for supply from a vaccination site to a temporary site must be carried out under Regulation 3A(1) of Human Medicines (Coronavirus) (Further Amendments) Regulations 2022 under the supervision of a doctor, registered nurse or pharmacist. Supply must also be in accordance with NHSE guidance.
Moving punctured vials
If it is essential to transport a vial of any vaccine after first puncture, it should be in a cool box at 2 to 8°C and the vial must be used within 6 hours of first puncture. If a vaccinator has punctured and unpunctured vials in their possession, it is essential they are stored and transported separately to avoid the risk of confusion.
COVID-19 vaccines should be moved with care
All staff are remind reminded that 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 manufacturer’s SPC.
The following resources are available for information on the detailed characteristics of each vaccine or general guidance on transportation while maintaining the cold chain:
- Content rationalised and reformatted. Page title and para headings x 4 shortened. Paras 1 and 2 of "packing on a vaccination site" inverted.
- 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
- 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 !