Outpatient-prescribed medicinal products

Decree-Law 138/2023, of December 29, established the new local dispensing regime for prescribed medicinal products and other health products for hospital outpatients in the National Health Service (“NHS”). More recently, the regulations for implementation of the regime were published, i.e., Ordinance 104/2024/1, of March 14, and Ordinance 106/2024/1, of March 14.

The local dispensing regime allows patients to choose the location for dispensing medicinal products and other health products prescribed in a healthcare unit of the NHS, based on professional assessment.

Local dispensing of medicines and health products can take place in healthcare units of the NHS, community pharmacies and, in exceptional and duly justified cases, other dispensing locations.

Management and storage of medicines stocks are the responsibility of the Service of Common Usage of Hospitals (Serviço de Utilização Comum dos Hospitais - SUCH) and distribution at dispensing locations is ensured by a wholesale distributor.

The costs associated with storage, transportation and local dispensing of medicines are borne by the hospital unit responsible for the prescription, with funding being processed through a centralized mechanism managed by the Central Administration of the Health System (Administração Central do Sistema de Saúde - ACSS).

Local dispensing of medicines is supported by a technological system that will be developed by the Shared Services of the Ministry of Health (Serviços Partilhados do Ministério da Saúde - SPMS) and will allow registration of patients’ clinical information to be shared by the healthcare professionals involved in the process.

Locations that wish to adhere to the local dispensing regime must accept and comply with the following requirements:

• Registering information on local dispensing in the patient’s clinical record;

• Ensuring compliance with all storage conditions so that the medicines or health products maintain their quality, safety and efficacy;

• Communicating to the hospital pharmaceutical services the origin of any event verified during the use of the medicines or health products; and

• Complying with current legislation.

To join the dispensing regime, community pharmacies must register on the Infarmed licensing portal and participate in specific supplementary training on local dispensing recognized by Infarmed or by the Board of Pharmacists.

Although this regime came into force in May 2024, the technological system for local dispensing may not be available until the end of June 2024. In the meantime, the systems and processes of the existing dispensing regimes in hospital units of the NHS remain applicable.