On 24 August 2022, the Portuguese National Authority for Medicines and Healthcare Products (Infarmed) adopted Decision 089/CD/2022, which concerns the regulatory framework that sets out how holders of a manufacturing authorisation for medicinal products may acquire medicinal products without a national marketing authorisation (MA) in the European Economic Area. The regulatory framework is intended 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:
- Parenteral bags can only be produced in facilities that are authorised for the manufacture of medicines, and there can be no subcontracting in this respect.
- Parenteral bags without a national MA must be stored in a segregated, controlled and restricted-access area in MA holders' raw materials warehouses.
- Where medicines without a national MA have been purchased in the EEA but are not used due to the expiry date having passed or because they have been rejected, they must be destroyed and a record of the destruction must be sent to Infarmed on an annual basis.
- Medicine suppliers must be fully qualified prior to supplying medicines for the production of parenteral bags.
- A report on the qualification of suppliers of medicines without a national MA acquired in the EEA must be available at facilities where batches of parenteral bags are produced. Such reports must be made available to Infarmed for inspections.
- A detailed report must be sent to Infarmed every six months, containing the following information:
- the name of any medicinal products without a national MA acquired, the batch number, the expiry date, the quantity and the supplier;
- the quantity of medicinal products without a national MA used, including the final product in which they were used, the prescription number and the respective requesting and receiving hospital;
- the quantity of medicinal products without a national MA used for analysis in the quality control laboratory and the quantity stored for retention samples on its premises;
- the quantity of medicinal products without a national MA remaining at the end of each production batch and the quantity stored in the raw materials' warehouse; and
- the quantity of medicinal products without a national MA that were rejected.
Communications to Infarmed must be made by email to [email protected].
For further information on this topic please contact Eduardo Nogueira Pinto, Ricardo Rocha or Rita Antunes da Cunha at PLMJ by telephone (+351 213 197 300) or email ([email protected], [email protected] or [email protected]). PLMJ website can be accessed at www.plmj.com.