DILI, 16 december 2024 (TATOLI) – The Council of Ministers has approved a draft Decree-Law, presented by the Minister of Health, Elia A. A. dos Reis Amaral, concerning the regime for importing, storing, distributing, selling, and exporting pharmaceutical products and medical equipment.
This Decree-Law aims to replace Decree-Law 12/2004 of May 26th, adapting the legal framework to social, economic, and regulatory changes, both domestically and internationally.
“The new regulations promote separating import, storage, and distribution activities from pharmacy retail sales, ensuring greater specialization and strengthening public health protection. The activity of selling pharmaceutical products and medical equipment is also separated from the activity of providing medical, nursing, diagnostic, or therapeutic healthcare in pharmacies, the latter being prohibited in pharmacies,” said a statement.
There is also a ban on the ownership of more than one pharmacy per municipality and price coordination, preventing situations of oligopoly or monopoly that could jeopardize the population’s access to pharmaceutical products.
Among the main amendments is the requirement for specific conditions for storing and selling pharmaceutical products, such as strict temperature control, humidity, and light. The law also provides for differentiated spaces, both for storage and retail sales, for the storage and preservation of narcotics and psychotropic substances, and for pharmaceutical products ordered to be withdrawn from the market, expired, falsified, adulterated, or broken.
The Decree-Law also establishes the mandatory existence of a permanent and exclusive technical director, a pharmacist, and the submission of monthly reports to the Ministry of Health, which should include import, storage, and sales activities.
The new regime introduces reinforced inspection measures and penalties, intending to ensure the quality and safety of pharmaceutical products available on the market. It also provides for a 180-day transition period, allowing organizations currently operating to adapt to the new rules. The law comes into force the day after its publication, revoking Decree-Law 12/2004, of May 26th.
TATOLI
