MA withdrawal: voluntary withdrawal of a marketing authorisation

A holder may ask for its marketing authorisation to be withdrawn at any time. Article 23a of Directive 2001/83/EC requires the holder to notify the competent authority when the product ceases to be placed on the market, temporarily or permanently, at least two months before the interruption, except in exceptional circumstances; Article 13(4) of Regulation (EC) No 726/2004 sets the same duty towards EMA for centrally authorised products. Article 123(2) of the Directive adds that the holder must forthwith notify the Member States concerned of any action to suspend marketing, withdraw the product from the market, or request the withdrawal of the authorisation, together with the reasons, and must state whether the action relates to efficacy or safety.

Withdrawal of an authorisation is distinct from withdrawal of a product from the market, from a recall of batches, and from the withdrawal of an application during assessment. For centrally authorised products the holder writes to EMA, the CHMP takes note and the European Commission adopts a decision that removes the product from the Union register. For national, MRP and DCP authorisations each Member State has its own form and procedure, and in MRP the RMS should be told so that the assessment history stays coherent for the remaining countries.

The decision has consequences beyond the authority. Pharmacovigilance obligations continue until the authorisation ends, parallel distributors and importers must be informed, remaining stock may be sold under conditions the authority sets, and the holder must consider patients who depend on the product. Where the product is the only one of its kind, authorities may ask the holder to delay or to transfer the authorisation to another company instead.

What goes wrong: notifying the withdrawal less than two months before supply stops; forgetting that a withdrawal for safety reasons must be declared as such, which triggers EU-wide information under Article 107i; leaving pending variations and renewals open, so fees are charged for a product that no longer exists; and withdrawing in one country while the same product remains authorised in others without a plan for the harmonised product information.

Under the new pharma package (not yet in force), a holder must notify at least twelve months before permanently ceasing supply or requesting withdrawal, and must publicly offer to transfer the authorisation before withdrawing a critical medicine; see shortage changes.