Acquisition of intended exclusively for the production of parenteral bags
INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags.
This regulatory framework follows the need of holders of a manufacturing authorisation for medicinal products to acquire, within the European Economic Area (“EEA”), medicinal products without a national Marketing Authorisation (“MA”), solely and exclusively for the production of parenteral bags.
The possibility to buy medicinal products without a national MA is subject to the following requirements:
(i) Name of the medicinal products without a national MA acquired, batch, expiry date, quantity, and supplier;
(ii) Quantity of medicinal products used without a national MA, identifying the final product in which they were used, prescription number and respective requesting and receiving hospital;
(iii) Quantity used of medicinal products without national MA in the Quality Control Laboratory, in laboratory analysis, and the quantity stored for retention samples on its premises;
(iv) Quantity remaining of medicinal products without a national MA at the end of each production batch and stored in the raw materials' warehouse;
(v) The rejected quantity of the medicinal products without a national MA that have been acquired.
The obligations concerning communications to INFARMED must be performed by email to bolsas-parentericas@infarmed.pt.
This Decision came into effect on 24 August 2022.