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In the context of the Covid-19 pandemic, the INFARMED has published a set of recommendations that may be enforced by Sponsors, clinical trial centres and research teams on the ongoing clinical trials in Portugal. The purpose of implementing these recommendations is to ensure the safety and protection of the participants.
The recommendations published by the INFARMED are also extended to clinical studies related with the intervention of cosmetics or medical devices.
These exceptional measures relate, inter alia, with aspects, such as the suspension of participant recruitment, the execution of clinical evaluation and clinical trial procedures using telematic means and the direct domicile dispensing of experimental medical products.
The adoption of these exceptional measures should be decided by the Sponsor, jointly with the Investigator, through proportionality and suitability criteria, based on a risk analysis for each clinical trial and taking into account the characteristics of said trial, the trial site and the inherent epidemiological risk.
Decree-Law no. 14-E/2020, of 13 April, established an exceptional and temporary regime for the design, manufacture, import, national commercialization and use of medical devices for human use (“MD”) and personal protective equipment (“PPE”) in the context of the prevention of contamination by SARS-CoV-2. Said Decree-Law should take effect since March 13, 2020.
At an European level, Commission Recommendation (EU) 2020/403, of 13 March 2020, on conformity assessment and market surveillance procedures, had already encouraged the adoption of all necessary measures to support the efforts of providing PPE and MD in the context of COVID-19, in order to respond properly to the increased demand for said products.
To this end, the manufacture, import, placing and availability on the national market of MD and PPE, which are identified in the Annex of the Decree-Law, are subject to procedures for conformity assessment with the legally required health, safety and performance requirements, which result in the affixing of the “CE” marking, being possible for such procedures to be adapted or waived.
Ordinance no. 90-A/2020, of April 9, eases the rules on the dispense of medicines, with the intention of preventing users from travelling to health units with the purpose of renewing the prescription (the validity of which ceases during the state of emergency). In this sense, said Ordinance is aligned with the measures adopted to restrict the movement of persons, simultaneously guaranteeing access, namely by the chronically ill, to prescription medicines.
For this purpose, an exceptional and temporary regime has been established for the electronic prescription of medicines and the respective medical prescription, which should take effect during the period of validity of the state of emergency and also during its eventual renewals.
Electronic medical prescriptions, valid for six months and that expire after the date of entry into force of said ordinance, shall be considered automatically renewed for the same period. The new validity term of the automatically renewed prescription shall be counted from the date of expiry of the initial prescription.
Decree-Law 10-A/2020 established exceptional and temporary rules, in the context of the current epidemiological situation, particularly for public procurement purposes. The objective of this flexible regime is to allow the swift acquisition of the products needed to combat COVID-19.
These exceptional measures are applicable to entities in the corporate public sector and the administrative public sector and, with the necessary adaptations, to local municipalities.
The procedures covered by this flexible scheme are those whose services are aimed to meet the needs of the contracting entities related to actions of prevention, containment, mitigation, treatment of infection by COVID-19, as well as the restoration of normality following the pandemic.
Therefore, and among other available mechanisms, the possibility of using the simplified direct adjustment scheme is extended and the legal limits for repeating adjustments to the same economic operator are eliminated.
It should also be noted that contracts entered into by direct adjustment under this exceptional regime, regardless of whether they are or not in writing, may produce all their effects immediately after being awarded, waiving publicity as a condition for these contracts to take effects.
The European Commission has adopted a proposal to postpone the implementation of Regulation (EU) 2017/745 on medical devices with the aim of allowing Member States, health institutions and economic operators to focus on the combat against the pandemic caused by the new coronavirus. It should be noted that this postponement proposal has already been approved by the Parliament and the European Council.
The European Commission wants to avoid potential market disruption regarding the availability of safe and essential medical devices, as the coronavirus pandemic requires the provision of additional resources considered vital, such as ventilators, assistive devices, technology, and vaccines.
This postponement prevents potential delays in the availability of these medical resources, said delays are inherent to the limitations of the authorities or bodies’ capacity to assess the products’ compliance with the new Regulation.
The application of the Regulation will be postponed for one year, i.e. until 26 May 2021, allowing the manufacturers of the products covered by said Regulation more time to prepare its application.
The content of this information does not constitute any specific legal advice; the latter can only be given when faced with a specific case. Please contact us for any further clarification or information deemed necessary in what concerns the application of the law.