The measure, initially established with effect from January 30, 2021, has been extended through the EU Commission Implementing Regulation 2021/442, of March 11, 2021, arguing as its main motivation, the latent risk in the lack of supply of vaccines against Covid-19 in EU member states.
Thus, both the vaccines entirely manufactured in the EU, as well as the active principles (including banks of standard cells, working cells and samples) of these, originating in the EU or from a third country (previously imported into the EU) that have been used in the manufacture of these vaccines will be subject to an export authorization that must be presented when the goods are declared for export and, at the latest, at the moment in which the control customs office declares the release.
The HS Codes of the EU Combined Nomenclature affected by this regulation are the following: 3002.20.10, ex 2933.99.80, ex 2934.99.90, ex 3002.90.90 and ex 3504.00.90.
The export authorization must be completed by the exporter, stating, among other information, the name of the manufacturer identified in Annex II of said Regulation.
It is important to note that, for the purposes of this Regulation, filling and packaging activities within the EU are considered manufacturing operations, which is why both the titular laboratories in charge of the manufacture of the vaccine and those whose activity of manufacturing consists of filling and packaging, are capable of being individually identified for the purposes of Annex II of this Regulation.
The Regulation exempts from the presentation of authorization to shipments of vaccines that are destined for a country in Continental Europe, from COVAX (Global Access Fund for Vaccines), from the Pan-Mediterranean region and from North Africa, mainly.
Finally, it should be noted that, without the presentation of the valid export authorization, the export of pharmaceutical preparations classified in the aforementioned HS codes from the customs territory of the EU is prohibited.
Salinas & Partners, with more than 30 years of experience advising on Customs and International Trade, is at your disposal if you want more information, advice or assistance in relation to the content of this informative note.
