PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices 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 trans- portation and distribution. The MDR and Decree- Law 29/2024 apply to medical devices. INFARMED is the entity responsible for monitor- ing compliance with these regulations. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Any natural or legal person can be an importer of medicines 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 medi- cal devices require the economic operator to be licensed by INFARMED for that purpose. For personal use, medicines can be transported only for the necessary period, provided that they are accompanied by a medical prescription, when necessary. In the case of emergencies or dona- tions, INFARMED will assess each case individu- ally. 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 cus- toms territory of the European Union:
For medical devices, facilities must obtain an industrial activity licence in accordance with the applicable legislation and have an industrial activity code associated with the categories of medical devices produced in conjunction with the respective manufacturing activities per- formed. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices INFARMED issues authorisation for the whole- sale of medicines. It covers supplying, holding, storing, or delivering medicines for processing, resale, or use in medical services, healthcare facilities, and pharmacies, excluding the sup- ply to the public. It specifies the facilities from which distribution is carried out and is subject to the validity of the certificate of good distribu- tion practices, which must be renewed every five years. The wholesale of medical devices is subject to prior notification to INFARMED. It covers supply- ing, holding, storing or supplying medical devic- es for resale or use in medical services, health- care facilities, pharmacies and other points of sale to the public, excluding supply to the public. 6.2 Different Classifications Applicable to Pharmaceuticals For dispensing to the public, medicines are clas- sified into prescription-only medicines (MSRMs) and non-prescription medicines (MNSRMs). The former can also be classified as renewable, spe- cial or for restricted use in specialised monitored conditions, and the latter as MNSRMs for dis- pensing only in pharmacies.
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