Form: Decentralised Manufacture: The designation step application form

The Access Consortium — comprising regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland — works together to streamline regulatory processes, support innovation and improve global public health outcomes.

There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus ® tablets, with different stated mg dose but similar bioavailability, will both be available on the market.

The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.

How to comply with the regulatory requirements for manufacturing custom-made medical devices.

The appointment will involve a time commitment of approximately 22 days per year including 11 meetings. Remuneration for the roles will be at a rate of £325 per meeting.

List of Field Safety Notices from 23 to 27 June 2025.