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Marketing Authorization Application Regulatory Requirements

Goodwin

UK’s MHRA Grants Marketing Authorization for Chikungunya Vaccine

Goodwin on

On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

Hogan Lovells on

On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more

Hogan Lovells

EMA warns marketing authorisations holders to notify type I variations earlier

Hogan Lovells on

On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary closure of the EMA. The EMA will relocate from London to Amsterdam and will...more

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