Importing unlicensed and EMA centrally authorised medicines intended for other EU member states

In the latest blog from the MHRA’s Inspectorate, Mark Birse issues a reminder the about the importation of unlicensed and centrally approved medicines.

Centrally authorised medicines that have an EU marketing authorisations issued by the EMA, cannot be notified to the MHRA for importation as unlicensed medicines.  EMA approval is valid in all Member States so these products should not be considered unlicensed.  Only if importation is from outside the European Economic Area (EEA) for reasons of unavailability of the medicine throughout the EEA could such as an importation take place.

The right approach for distribution of centrally authorised medicines is by means of the European Medicines Agency (EMA) procedures for parallel distribution.  Parallel distribution is when a centrally authorised medicine on the market in one member state is distributed to another member state by a company independent of the marketing authorisation holder.  To be able to sell a medicine in other member states, parallel distributors must ensure that the packaging and labelling of the medicine is appropriate.  This means that the label, box and package leaflet are up-to-date and in the correct language for the country concerned.

The MHRA say that from time to time they receive notifications for importation of centrally authorised medicines for supply to other EU member states where the medicine is not yet available, where the supply will be to meet special needs of individual patients in the absence of an available licensed medicine.

The MHRA advises that they will object to notifications for import of an unlicensed medicine submitted in this manner on the grounds that the medicine is licensed and therefore technically available.

Click here to read the article.