We hereby inform the business community and other interested parties of recent amendments to the legal framework for setting up pharmacies, establishments and pharmaceutical products vending machines for the sale of pharmaceutical products at retail in the country, approved by Resolution no. 18/2025 of April 28, which approves the Regulation on the Legal Framework for the Licensing Establishments for the Sale of Pharmaceutical Products at Retail (the “Regulation”).

In effect, the Regulations, applicable to licensing applications for establishments selling pharmaceutical products at retail, repeals Ministerial Decrees no. 242/2011 of 7 October and 55/2010 of 23 March and establishes that existing pharmacies must adjust to the current requirements in terms of infrastructure, painting and equipment within one year of the publication of the decree.

The Regulations classify establishments according to the type of service they provide, with pharmacies being of type “A”, “B” and “C”.  Pharmaceutical sales outlets are establishments owned by a pharmacy which dispense and sell pharmaceutical specialties at retail and pharmaceutical products vending machines are devices for the packaging and automatic sale of medicines on the restricted list of over-the-counter medicines approved by ANARME.

In order to be licensed under these Regulations, establishments are required to provide proof of legal existence, technical capacity and financial capacity. Compliance with the minimum working equipment and pharmacy equipment is required, as well as technical management.

With the entry into operation of ANARME – the regulatory authority for the medicines sector – the development and increase in regulation in the sector is notable, which is justified, especially as relates to sensitive matter such as public health, which must be widely regulated and monitored. In general, the Regulations are a consequence of ANARME's intensified regulatory activity, but it also demonstrates an openness to the technological world in the sector, by allowing the use of pharmaceutical products vending machines, as can be seen in other parts of the world.