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Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless the import is from outside the EEA for reasons of unavailability of the medicine throughout the EEA.

The correct method of distribution of Centrally Authorised medicines is by means of the EMA procedures for parallel distribution.   We posted about this topic in July last year - Importation of unlicensed medicines and centrally authorised products - A helpful reminder

Occasionally, we receive notifications for import of Centrally Authorised medicines for supply to other Member States where the medicine is not yet available in the correct pack for their market and where the Member State may regard the supply to be intended to meet special needs of individual patients in the absence of an available licensed medicine.

The MHRA will object to notifications for import of an unlicensed medicine submitted in this manner on the grounds that the medicine is in fact licensed and available. Consequently, it cannot be notified for import as an unlicensed medicine.

Our previous advice applies as to the correct procedures for distribution and supply of Centrally Authorised medicines.

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Access our guidance on good practice for information on the inspection process and staying compliant.

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