Medicines shortages: regulatory processes to manage supply disruptions
Published 23 May 2022
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This publication is available at https://www.gov.uk/government/publications/medicines-shortages-regulatory-processes-to-manage-supply-disruptions/medicines-shortages-regulatory-processes-to-manage-supply-disruptions
Expedited assessments
New applications for Marketing Authorisations and product variations can be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC).
Contact us to discuss your fast track application.
New marketing authorisation application tools and guidance
- Marketing authorisation application guidance
- Pre-submission checklist
- Electronic Application Form and Cover Letter Tool
- Extedo EURs validator
- Lorenz eValidator
- Handling of Active Substance Master Files and Certificates of Suitability
- Summary of Product Characteristics (SmPC) MS Word Template
Product variation application tools and guidance
- Medicines: apply for a variation to your marketing authorisation
- Marketing Authorisation Variations - Supplementary Guidance
- When the unexpected happens: Batch Specific Variations
Temporary exemptions to labelling requirements
Marketing authorisation holders (MAHs) can apply for an temporary exemption to supply packs intended for another country to Great Britain (GB) or Northern Ireland (NI) to mitigate supply disruptions.
Exemptions are granted for a defined period of time or to cover specific batches.
The product supplied must be identical to the UK licensed product, except for the packaging.
Apply for an exemption.
Importation of licensed medicines
Licensed medicines may be imported to an alternative authorised site under quarantine with appropriate quality controls whilst testing concludes.
Products should not be placed on the market until they has been QP[footnote 1] certified.
Unlicensed medicines
Manufacturers can apply to import unlicensed medicines for the UK market to meet a patient’s individual needs.
Unlicensed medicines importation applications and guidance
Inspections
Manufacturers and distributors can apply to vary licences to mitigate supply disruptions.
Contact us to discuss your application.
Community pharmacies and wholesalers
Pharmacists may supply small quantities of a medicine to another pharmacist to meet a patient’s individual needs without the requirement of a Wholesale Dealer’s Licence
Wholesalers are encouraged to use quotas to ensure fair distribution of medicines to mitigate supply disruptions
Further guidance on regulatory processes to manage supply disruptions
In May 2022 the MHRA supported the work of the Department of Health and Social Care’s HRT supply taskforce to make sure women can continue to access vital Hormone Replacement Therapy (HRT) products. We supplemented existing guidance on regulatory processes to respond to supply disruptions by holding workshops.
See further information in our HRT supply workshop guidance
Contact
Contact us via email to receive further information before making an application for any of the above processes, or call (weekdays 9am to 5pm): 020 3080 6000
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A Qualified Person (QP) is responsible for assuring the quality of medicines ↩