Amendments to the Procedure for Registration of Medicinal Products

Amendments to the Procedure for Registration of Medicinal Products

Please note that the amendments to the Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” came into force on 13 April 2018.

The amendments specify the procedure for review, approval and rejection of variations of marketing authorisation 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 marketing authorisations for medicinal products for human use and veterinary medicinal products.

The amendments also introduce a decrease in the time for primary expertise to review marketing authorisation and renewal documentation of medicinal products authorised in the mutual recognition procedure (MRP) and decentralised procedure (DCP). From now on these applications shall be reviewed within 14 days following receipt of the information from the reference member state regarding initiation of primary expertise (instead of the 30 days for marketing authorisation and 10 days for renewal prior to this). Primary expertise for renewal of medicinal products authorised in the national procedure shall also be carried out within 14 days following receipt of application at the State Agency of Medicines. For marketing authorisation in the national procedure – within 30 days.

The time for conducting of primary expertise on applications for variations to marketing authorisation documentation has also been specified: 7 days for applications for type IB variations, for type II variations – 14 days.

The new amendments also foresee changes in the procedure for submission of applications for approval of marketing authorisation, renewal and variations, as well as in the procedure for notifications regarding approval of variations in marketing authorisation documentation.

From now on notifications regarding approval or rejection of variations to medicines authorised in the national procedure, as well as medicines authorised in DCP and MRP procedures where Latvia is the reference member state shall be published on the website of the State Agency of Medicines www.zva.gov.lv. Whereas in case of rejection of variations, in addition to the published information the State Agency of Medicines shall send the decision regarding rejection of variations to the marketing authorisation holder.

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.

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.

Technical amendments have also been made.

* Cabinet of Ministers Regulation No. 210 of 10 April 2018 “Amendments to the Cabinet of Ministers Regulation No. 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” in Latvian.