PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
to comply with pharmacovigilance obligations and to make this or other data proving that the benefit-risk relationship of the medicine remains favourable available to INFARMED. Manufacturers of medical devices other than investigational devices must report any field safety corrective action to INFARMED, as well as any serious incident or any statistically signifi- cant increase in the frequency or severity of inci- dents that are not serious incidents or that are expected to have undesirable side effects that could have a significant impact on the benefit- risk analysis, and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices INFARMED publishes information on the status of an MA application and its assessment report on its website. It suppresses any commercially confidential information 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 medicines and medical devices may be created and applied in very specific circumstances, such as those caused by the COVID-19 pandemic. However, the Portuguese regulatory framework does not generally provide for a specific fast- track mechanism for the registration of medi- cines and medical devices.
In the case of medicines, the applicant may submit a reasoned request for the accelerat- ed assessment procedure, which reduces the assessment period of the application, based on a major public health interest, in particular from the perspective of therapeutic innovation, as provided for in Regulation (EC) 726/2004 of the European 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. Nevertheless, as an EU member, Portugal is covered by the mutual recognition agreements between EU and third-country authorities con- cerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manu- facturing practice inspections and batch certifi- cation of human and veterinary medicines. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices The manufacture of medicines, experimental medicines and medical devices requires authori- sation from INFARMED. The manufacture of medicines requires the exist- ence of facilities licensed for the purpose and compliance with good manufacturing practices. The facilities are subject to periodic inspections by INFARMED, which certifies their compliance and issues a certificate of good manufacturing practices, valid for three years.
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