On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft

This Annex summarizes the GMP requirements applicable to a Manufacturing Import  Authorisation (MIA) holder which imports medicinal products (human and veterinary)  from outside the EU/EEA. The guidance in the main chapters and annexes of the EU GMP also apply, as appropriate for the activities carried out, and should be consulted  for more detailed guidance.
Medicinal products which enter EU/EEA with the intention of export only and which are not processed nor released for placing on the EU/EEA market, are not covered by  this Annex.