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Newsletter Life Siences Nº2/2020

New Hemp Cultivation and Industrial Exploration Regime in Portugal

The Regulatory Decree No. 2/2020 of August 4th was published, which establishes the authorization system for the cultivation and industrial exploitation of varieties of hemp.

The cultivation of hemp has sparked interest at a national and an international level, particularly for medicinal, cosmetics and industrial purposes. However, there were doubts about the procedure and competent entity for granting the authorization for cultivation.

In this sense, the mentioned Regulatory Decree No. 2/2020 establishes that the authorization should be sought before the Directorate General of Food and Veterinary, and the control functions are carried out by the Institute for Agriculture and Fisheries Financing, I. P, together with the Judiciary Police, the National Republican Guard and the Public Security Police.

The legal diploma also clarifies that the need to obtain authorization for hemp production is due to the fact that the varieties of Cannabis sativa for industrial use are not distinguishable from varieties with tetrahydrocannabinol (THC) contents higher than 0.2%, and there may occur increases in THC contents above those defined by the common organization of markets for industrial hemp.

The Regulatory Decree in question thus responds to the uncertainty, highlighting the economic and agricultural potential of this plant species.

Simplification of the licensing procedure for the production of medical devices and personal protective equipment

In order to promote the mobilization of the national business fabric to collaborate in combating the pandemic, namely through the reconversion of production lines, Decree-Law No. 36/2020 of July 15th was recently published, which simplifies the licensing procedure for industrial establishments producing medical devices, personal protective equipment, ethyl alcohol and disinfectant biocidal products in Portugal.

An exceptional and temporary regime had previously been introduced in Portugal for the design, manufacture, import, marketing and the use of medical devices for human use and personal protective equipment in the context of the COVID-19 pandemic.

This is intended to eliminate the procedural complexity associated with the introduction of changes to the production of these industrial establishments.

With regard to the availability and placing on the market of social masks, the aforementioned Decree-Law no. 36/2020 also stipulates that the manufacture and import of these products will have, as defined for other medical devices for human use and personal protective equipment, to comply with the technical specifications advertised for this purpose in Decree-Law no. 14-E/2020 of April, 13th.

The STAYAWAY COVID App is already available in Portugal

The STAYAWAY COVID is a digital proximity tracking system that is already available and uses Bluetooth technology as a proximity sensor to alert its users that they have been less than 2 meters away, for more than 15 minutes, from the device of another user who was later on diagnosed with the new coronavirus.

After the statements issued by the National Commission for Data Protection (“CNPD”), Decree-Law No. 52/2020 of August 11th established that the Directorate General of Health is responsible for processing data from the mentioned system.

Furthermore, this Decree-Law determines that in order to obtain the pseudo-random legitimation code (for subsequent insertion in the application), no identifiable data of the patient is required, but rather the date of the first symptoms or of the laboratory test (in case the patient is asymptomatic). Once this code has been generated, the user can insert it into the application to signal the positive case.

In the same direction as the CNPD’s statements, this Decree Law notes that the interoperability of STAYAWAY COVID with other mobile systems and applications must ensure respect, among others, for the principle of data minimization.

Fee waiver for temporary and exceptional health care structures in Portugal

In the context of the current epidemiological situation, Ordinance No. 126/2020 of May 26th waives the fees for registration & regulatory contribution associated to temporary and extraordinary health care structures.

The mentioned Ordinance follows the mobilization of different agents to assist in the prevention and mitigation of the pandemic. This mobilization was demonstrated through the initiatives promoted by the local authorities for the installation of tents and pavilions for the reception (if necessary) of people infected with COVID-19 or even the installation of biological material collection stations for the analysis of infection by SARS-CoV-2.

It was therefore considered necessary to establish an exceptional regime of fee waiver of registration fees and regulatory contributions in cases where health care is provided in these facilities.

This fee waiver will be in force until the end of 2021, and will apply to COVID-19 testing centers or units, regardless of the person, natural or legal, who owns, oversees, manages, operates or otherwise exercises control over such structures.

Exceptional and transitional regime for testing and diagnosis of SARS-CoV-2 in Portugal

In the context of the current pandemic, the laboratory diagnosis of SARS-CoV-2 is an essential element regarding the efforts to contain the disease, thus recognizing the need to strengthen and expand the diagnosis network in Portugal.

The collection of biological products for the aforementioned laboratory testing has been carried out in the facilities of the laboratories referenced for the diagnosis of SARS-CoV-2, in available collection stations and in screening centers to COVID-19, which are located in various regions of the country.

However, the verification of technical requirements for the operation of these structures is subject to license, obtained in the context of an ordinary licensing procedure, whose complexity is considered incompatible with the current testing needs.

In this sense, Ordinance no. 218-A/2020, of September 16th, which has been in force since March 2nd, 2020, established an exceptional and transitory regime, which exempts the mentioned entities from the application of the ordinary licensing procedure, for the verification of the technical operating requirements applicable to the valence of molecular pathology.

Furthermore, the screening centers to COVID-19 are authorized to collect and harvest for the laboratory diagnosis of SARS-CoV-2, outside the facilities of the referenced laboratories.

Conducting clinical trials of medicines with GMOs in the EU

Regulation 2020/1043 was recently approved by the Parliament and the European Council and aims to accelerate the conduct of clinical trials in the European Union on experimental products containing or consisting of Genetically Modified Organisms (GMOs) that can be used in therapies and vaccines for the treatment of VOCID-19.

This Regulation followed the proposal put forward by the European Commission, according to which, during the pandemic and by way of derogation from Community legislation on GMOs, prior environmental risk assessment or consent from national authorities should not be required for such clinical trials.

Regulation 2020/1043 thus stipulates that none of the operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent VOCID-19, with the exception of the manufacture of investigational medicinal products, require prior environmental risk assessment or authorization.

Authors:

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.

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