Amendments to the Procedure for Registration of Medicinal Products That Came into Force on 13 April 2018
We would like to inform you, that amendments to the Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” came into force in Latvia on 13 April 2018. The amendments specify the procedure for review, approval and rejection of variations of marketing authorisation (MA) documentation in order to ensure compliance with the European Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of MA for medicinal products for human use and veterinary medicinal products.
The review timelines for primary expertise have been shortened for MA application and renewal documentation of medicinal products authorised via MRP and DCP procedures:
Initiation of primary expertise – 14 days (instead of the 30 days for MA application and 10 days for renewal prior to this).
Primary expertise for licence renewal – 14 days following receipt of application at the State Agency of Medicines. For MA in the national procedure – within 30 days.
The time for conducting of primary expertise on applications for variations – 7 days for applications for type IB variations, for type II variations – 14 days.
Notifications regarding approval or rejection of variations shall be published on the website of the State Agency of Medicines www.zva.gov.lv.
The amendments also lay down the criteria for rejecting transfer of marketing authorisation holder and clarify the data to be submitted in case of transfer of marketing authorisation holder, withdrawing the requirement to submit a document verifying the transfer of marketing authorisation holder in addition to the application.
Lastly – a mandatory requirement was also introduced laying down that from 1 June 2018 marketing authorisations must be issued in the format of an electronic document.