EMA Has Not Received Covishield Approval Request: EU Official

The EU official reportedly said EMA does not probe new drugs on its own unless asked by the relevant companies.

The European Medicines Agency (EMA) has not received any request for approval of authorisation of the Covishield vaccine, ANI reported on Tuesday, 29 June, quoting a European Union (EU) official.

"Concerning a possible EMA authorisation for Covishield, as of yesterday, the European Medicine Agency (EMA) stated that it had not received a request for approval. It will examine any such request when received, as per its procedures."

EU official to ANI

Further, the official informed ANI that the EMA does not investigate new drugs on its own, unless it is asked to do so by the relevant companies.

WHAT ABOUT TRAVEL TO EU COUNTRIES FROM INDIA?

With regard to travel to the EU countries from India, the official said:

”…temporary restrictions on non-essential travel to the EU are currently in place from many non-EU countries, including India, due to COVID. EU member States shall gradually lift these temporary travel restrictions at the external borders, based on developments of the health situation.”

The European Union is now introducing the EU Digital COVID Certificate.

While the aim of the EU Digital COVID Certificate is to facilitate free and safe movement inside the EU, amid the pandemic, it is reportedly not a pre-condition to travel.

The EU official has also, as per ANI, confirmed that member states of the EU will have the option to accept vaccinations that have been authorised by the World Health Organization (WHO), including Covishield.

PREVIOUSLY

A day after Europe announced a 'green pass' for travellers vaccinated with Pfizer, Moderna, AstraZeneca and J&J COVID-19 vaccines, CEO of Serum Institute of India (SII), Adar Poonawalla, on 28 June, Monday, reassured Covishield-vaccinated Indians facing trouble with travel to the European Union that the matter will be resolved soon.

"I realise that a lot of Indians who have taken Covishield are facing issues involving travel to the EU. I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries," Poonawalla said in a tweet.

(With inputs from ANI.)