Decree Law No. 36/2020
- Issuer: Presidency of the Council of Ministers
- Diploma Type: Decree Law
- Number: 36/2020
- Pages: 3 - 9
Summary in plain english
This decree-law makes the first amendment to the diploma that establishes an exceptional and temporary scheme for the design, manufacture, import, national marketing and use of medical devices for human use and personal protective equipment.
Given the public health emergency of international scope, declared by the World Health Organization on 30 January 2020, as well as the classification, on 11 March 2020, of the COVID-19 disease as a pandemic, the Government has been approving a set of extraordinary and urgent measures in several matters.What is going to change?
This decree-law provides for a simplified system of industrial licensing, of an exceptional and temporary nature, applicable to changes in industrial establishments, for the manufacture of medical devices, personal protective equipment, ethyl alcohol and disinfectant biocidal products, which are intended to prevent the spread of the new coronavirus (SARS-CoV-2).
The Type 1 establishments, i.e. establishments with the highest relative hazardousness, namely those subject to environmental impact assessment, environmental licence, major accident prevention scheme or operating hazardous waste, as well as Type 2 establishments, i.e. establishments operating non-hazardous waste or with the framework of the European greenhouse gas emission allowance trading scheme are subject only to a change request made by e-mail to IAPMEI - Agency for Competitiveness and Innovation.
This procedure takes place within a maximum of five working days.
For establishments which do not fall under types 1 and 2, and therefore those designated as type 3, there is no need for mere prior communication of change.
It further clarifies the scheme of availability and placing on the market of the products covered by the diploma and, in particular, the manufacturing and marketing scheme applicable to social masks.
It is envisaged that medical devices and personal protection equipment are placed and made available in the national market, whenever the maintenance of their health, safety and performance characteristics is guaranteed, as well as that respiratory protection masks, masks for social use and single-use gloves in automatic machines may be made available.What advantages does it bring?
This decree-law aims to put an end to the complex procedure associated with changes to industrial establishments for the manufacture of this type of products (personal protective equipment, medical devices and disinfectants), thus allowing national entrepreneurs to collaborate with their production lines in the manufacture of these products, in order to fight the COVID-19 disease pandemic.When does it enter into force?
This decree-law enters into force on 16 July 2020 and takes effect from 13 March 2020.
Legal translator is the translation of texts within the field of law