MHRA Seeks Info on Drug Supply Issues Related to COVID-19
To help manage the UK supply of medicines, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday reminded marketing authorization holders (MAHs) that they need to provide information about any supply issues they are experiencing as a result of COVID-19.MAHs should focus on the entire supply chain of the active substance and medicinal product, including manufacturing sites of the starting materials and packaging materials for the medicinal product, as well as any other materials deemed critical through a risk assessment of the manufacturing process, the guidance says.
MHRA also notes EU guidance that says: “Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.”
For GMP supply issues, MAHs should notify the MHRA of any potential disruption to supply by emailing [email protected].
Guidance: Managing potential supply issues with medicines during Coronavirus (COVID-19)