Market authorisation holder (MAH) and Protocol on Ireland/Northern Ireland

Question for written answer  E-001432/2021
to the Commission
Rule 138
César Luena (S&D)

A current major challenge concerns the interpretation of Directive 2001/83/EC as listed in Annex 2 of the IE/NI Protocol, according to which the MAH for any pharmaceutical product placed on the market in Northern Ireland must be established in the EU, the EEA or in Northern Ireland, but may not be established in Great Britain. This will have impacts on pharmaceutical operators and authorities, with regulatory, fiscal, operational and financial consequences, while the standards regarding safety and efficacy will not be impacted, as this only concerns the location of the MAH. It is estimated that the request to change the MAH may affect around 9 000 marketing authorisations, potentially impacting access to medicines for patients in NI and disrupting access for neighbouring countries such as Ireland.

Is the Commission analysing the possibility of introducing a derogation for the duration of the applicability of the IE/NI Protocol to allow an entity established anywhere in the UK to act as MAH for marketing authorisations valid in Northern Ireland, given the fact that the regulatory authority for Northern Ireland is the UK’s regulatory authority?