Please note that pursuant to Regulation (EU) no. 568 of 23 April 2020, in view of the protracted epidemiological crisis and the need to ensure the European Union the availability of personal protective equipment referred to in Annex 1 of the aforementioned Regulation, the export of the same to non-EU countries will continue to be subject to authorisation by this Administration, for a further period of 30 days from 26 April 2020. Compared to Regulation (EU) 402/2020 there is a reduction in the number of health care devices subject to authorisation (Annex 1) as well as an increase in the number of countries for which such authorisation will not be necessary (art. 2 paragraph 4 and paragraph 5).
Applications must be sent by certified e-mail to email@example.com.
In the presence of the necessary conditions listed in art. 3 par. 3 of the above-mentioned Regulation (EU) n. 568/2020, the granting of authorisations will take place - as before - (except in exceptional cases where the deadline can be extended by a further 5 days) within 5 working days from the receipt of the PEC, in coordination with the Civil Protection Department. However, if the protection devices are located in another EU Member State other than Italy, the authorisation of the Member State must be previously acquired by this Administration, which may grant or deny it within 10 days of the request. Finally, if the export of products for humanitarian reasons is involved, the authorisation procedure will be completed within two working days.
Applications will have to be submitted according to the authorisation form in Annex II of the Regulation, each field correctly filled in according to the explanatory notes. For humanitarian shipments, field 6 must necessarily be compiled.
The application may be submitted by the legal representative of the exporting company or by an intermediary trader expressly delegated by the exporter (accompanied by an identity document) to export personal protective equipment. In the case of shipment of products to a relative, a request from the person making the shipment will be enough.
The application for authorisation must be accompanied by:
- Commercial evidence proving that the sale of the goods takes place only in the cases referred to in art. 3 paragraph 3 of the Regulation, and from which the type of goods, the quantity, the units, the customs of departure of the goods, and the country of destination are clearly indicated.
- Possible delegation of the exporter.
- Self-certification by the exporter or economic operator who declares:
a) that the information contained in the application form is accurate and provided in good faith;
b)that the documents produced correspond to those in his possession and that he undertakes to keep them for five years;
c)that he is established in Italy.
- Consent to the processing of personal data under and for the purposes of Article 13 of EU Reg. 2016/679.
For any information, please write to the following e-mail address and indicate a possible address: