PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
ed use in specialised monitored conditions and the latter as MNSRMs for dispensing only in pharmacies.
• Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015. 7.5 Trade Blocs and Free Trade Agreements Portugal is part of the EU and a single European mar- ket. It applies the principle of free movement of goods and services and has harmonised regulatory rules for medicines and medical devices. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Price Control for Medicines Non-reimbursed medicines have free pricing arrange- ments, whereas all other medicines are regulated and subject to maximum or notified price rules. They can- not be sold unless the MA holder obtains a retail price (RP). The RP of the medicine is composed of: • the ex-factory price (EFP), which is the maximum price at the stage of production or import and has fixed rules for its determination; • the wholesalers’ and retailers’ selling margins, as fixed by ministerial order; • the tax on the sale of medicines; and • value-added tax (VAT). MSRMs intended for use in National Health Service (NHS) establishments are also subject to maximum price rules. Their final price is composed of: • the EFP; • the sales tax; and • the VAT. The prices of medicines subject to the maximum price rules are reviewed annually. The pricing rules for medi- cines are set out in Decree-Law 97/2015 of 1 June 2015 and regulated by several Ministerial Orders, in particular: • Ministerial Order 195-C/2015 of 30 June 2015; and • Ministerial Order 154/2016 of 27 May 2016.
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The import and export of medicines is regulated by Decree-Law 176/2006 of 30 August 2006 and by related legislation on good practice in transportation and distribution. The MDR and Decree-Law 29/2024 apply to medical devices. INFARMED is the entity responsible for monitoring compliance with these regulations. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Any natural or legal person can be an importer of med- icines and medical devices if they are duly authorised and licensed for that purpose by INFARMED. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The import and export of medicines and medical devices require the economic operator to be licensed by INFARMED for that purpose. For personal use, medicines can be transported only for the neces- sary period, provided that they are accompanied by a medical prescription when necessary. In the case of emergencies or donations, INFARMED will assess each case individually. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The following regulations are to be considered upon the importation of any products into the Portuguese territory, which is part of the customs territory of the European Union: • Regulation (EU) 952/2013 of the European Parlia- ment and of the Council of 9 October 2013, which approves the Union Customs Code; • Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015; and
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