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:
- The production of parenteral bags can only be carried out in the facilities already authorised for the manufacture of medicines, and there can be no subcontracting in this respect;
- Medicines without a national MA must be stored in the warehouses of raw materials for the production of parenteral bags of the MA holders in a segregated, controlled, and restricted-access area.
- A record of the destruction of medicines without a national MA purchased in the EEA and not used due to the expiry date or because they have been rejected must be sent to Infarmed on an annual basis.
- In the production of these parenteral bags, it is not possible to use medicines without the qualification process for medicine suppliers having been concluded.
- The report on the qualification process of suppliers of medicines without a national MA acquired in the EEA used must be available at the production facilities of batches of parenteral bags in order to be made available to Infarmed for inspections.
- A detailed report must be sent to Infarmed every six months, containing the following information:
(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 content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.