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Parliamentary question - P-004529/2021(ASW)Parliamentary question

Answer given by Mr Reynders on behalf of the European Commission

The acceptance of COVID-19 certificates issued by San Marino and covered by Commission Implementing Decision (EU) 2021/1273[1] is subject to the same rules as the acceptance of EU Digital COVID Certificates issued by Member States.

According to the EU Digital COVID Certificate Regulation[2], where Member States accept proof of vaccination in order to waive travel restrictions, they are obliged to accept certificates for EU-authorised vaccines. Member States may also waive restrictions for holders of certificates indicating other vaccines.

San Marino is issuing vaccination certificates for COVID-19 vaccines Comirnaty, Moderna, Vaxzevria, Janssen and Sputnik V[3]. Whether or not their acceptance by Member States is mandatory or optional will thus depend on the vaccine administered.

The European Medicines Agency (EMA) rolling review for the Sputnik V is currently ongoing[4]. The timetable of the review depends on when the company is able to supply the required data and respond to any questions raised by EU experts during the evaluation. Once EMA’s Human Medicines Committee (CHMP) decides that sufficient data is available, the company can submit a formal marketing authorisation application (MAA), which is then processed under a shortened timetable. The same steps were followed for all the other COVID-19 vaccines that are currently authorised in the EU.

EMA will update its website[5] to announce the start of the evaluation when the MAA for the vaccine has been submitted.

As test and recovery certificates are also covered by Commission Implementing Decision (EU) 2021/1273, citizens of San Marino that have been vaccinated with Sputnik V can use those certificates when travelling within the EU.

Last updated: 1 December 2021
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