PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
site. It suppresses any commercially confidential infor- mation and allows access to the summary of product characteristics, the package leaflet and information on the medical devices placed on the market. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Fast-track procedures for the registration of medi- cines and medical devices may be established and applied in very specific circumstances, such as those arising from the COVID-19 pandemic. However, the Portuguese regulatory framework does not generally provide for a specific fast-track mechanism for the registration of medicines and medical devices. In the case of medicines, the applicant may submit a reasoned request for the accelerated assessment procedure, which reduces the assessment period of the application, based on a major public health inter- est, from the perspective of therapeutic innovation, as provided for in Regulation (EC) 726/2004 of the Euro- pean Parliament and of the Council of 31 March 2004. 4.2 Regulatory Reliance INFARMED has not issued authorisations based on specific Portuguese regulatory reliance rules. Nev- ertheless, as an EU member, Portugal is covered by the mutual recognition agreements between EU and third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice inspections and batch certification of human and veterinary medicines. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants The manufacture of medicines, experimental medi- cines and medical devices requires authorisation from INFARMED.
Facilities used to manufacture medicines must be spe- cifically licensed for that purpose and are required to comply with good manufacturing practices. The facili- ties are subject to periodic inspections by INFARMED, which certifies their compliance and issues a certifi- cate of good manufacturing practices, valid for three years. For medical devices, facilities must obtain an indus- trial activity licence in accordance with the applicable legislation and have an industrial activity code associ- ated with the categories of medical devices produced in conjunction with the respective manufacturing activities performed. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices INFARMED issues authorisation for the wholesale of medicines. It covers supplying, holding, storing, or delivering medicines for processing, resale, or use in medical services, healthcare facilities, and pharma- cies, excluding the supply to the public. It specifies the facilities from which distribution is carried out and is subject to the validity of the certificate of good dis- tribution practices, which must be renewed every five years. The wholesale of medical devices is subject to prior notification to INFARMED. It covers supplying, hold- ing, storing or supplying medical devices for resale or use in medical services, healthcare facilities, pharma- cies and other points of sale to the public, excluding supply to the public. MA Holders can be granted a simplified registration to distribute their own medicines through authorised third-party logistics operators. 6.2 Different Classifications Applicable to Pharmaceuticals For dispensing to the public, medicines are classified into prescription-only medicines (MSRMs) and non- prescription medicines (MNSRMs). The former can also be classified as renewable, special or for restrict-
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