IMPLEMENTING MHRA’S NEW GUIDANCE FOR OWN BRAND LABELLING OR ”VIRTUAL MANUFACTURERS”

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance which redefines Own Brand Labelling (OBL) as “Virtual Manufacturers” and contains more stringent requirements for demonstrating compliance. Virtual manufacturers with marketed products in the UK are now required to provide full technical documentation and audit quality management systems to corroborate alignment with the mandated regulations. The guidance reflects the EU’s initiative to increase product scrutiny and is expected to have a significant effect on the collaborations between “Original Equipment Manufacturers” (OEM) and OBLs. With the guidance coming into force on September 1, 2017, OEMs and virtual manufacturers have a significant undertaking ahead.

• Defining and fulfilling requirements for full technical documentation
• Approaches for handling proprietary data and justification for redaction
• Improving partnership agreements to ensure universal compliance

Speaker:
Theresa Jeary
Head of the Notified Body for Medical Devices
LRQA