# Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/b3a7f433-8c7f-4086-b31a-ab5851cb1e82
Type: Detailed Guide
Published: March 24, 2020

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance regarding the 'packing down' of large medicinal packs into smaller quantities during the COVID-19 pandemic. Normally, Manufacturer Specials (MS) license holders are restricted from packing down for retail sale under General Sales Legislation. However, to prevent shortages, the MHRA permits MS holders to distribute these products to community pharmacies temporarily. Key regulatory requirements include notifying the MHRA via email with a specific Excel spreadsheet detailing the shortage and packaging details. Labels must include the site's MS number, and every pack must contain a Patient Information Leaflet (PIL). All operations must remain compliant with Good Manufacturing Practice (GMP) obligations. Additionally, pharmacists in retail settings may prepare medicines for sale if done on-site and without advertising. This flexibility is strictly limited to the duration of the COVID-19 outbreak. While no specific violations by a single company are listed, the document sets clear boundaries to prevent unauthorized distribution outside these emergency protocols. These measures ensure that local supply chains remain functional while upholding safety and information standards for patients receiving redistributed medications.

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## Content

The MHRA has received several enquiries about whether organisations can ‘pack down’ large packs of licenced medicinal products into smaller quantities for retail sale. Any packs prepared under this guidance cannot be supplied under the General Sales Legislation. Manufacturers Specials ( MS ) licence holders Facilities with a Manufacturers Specials ( MS ) licence, may under normal circumstances pack down for their own use or in response to an order from a registered pharmacy, but not for retail sale. However, given the current COVID-19 situation, the MHRA are mindful that to ensure supply at the local level, some MS holders may be requested to pack down for distribution to community (retail) pharmacies. The MHRA does not object to this activity during the COVID-19 outbreak provided that: The activity is to enable supply continuity during the COVID-19 outbreak only. The MHRA are notified that the activity is taking place with a clear indication of any local shortage and its cause. Notifications should be forwarded to Covid19.GMDP@mhra.gov.uk using Pack-Down Notification ( MS Excel Spreadsheet , 43 KB ) The packaging details are included in that notification, such as pack size and labelling details. Labels should meet routine requirements and include the MS number of the site performing the pack-down operation. A patient information leaflet ( PIL ) is included in each pack This activity is performed in accordance with the GMP obligations for the MS license This guidance only applies during the COVID-19 outbreak. Registered pharmacy dispensing A pharmacist, or someone under their supervision in a retail pharmacy, can prepare or dispense a medicinal product where they are to sell it retail to a customer from that pharmacy premises and the medicinal product has not been advertised by that pharmacy. MHRA guidance on coronavirus (COVID-19) .

## Attachments

- [Pack-Down Notification ](https://assets.publishing.service.gov.uk/media/5e7a2bee86650c3712b47e1b/Notification_Template-v2.xls)