Information for marketing authorisation holders

14.11.2013.

The State Agency of Medicines (hereinafter - SAM) reminds you that the requirements regarding procedure for examination of variations for nationally authorised medicinal products laid down by the Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products (hereinafter - Regulation), Chapter IIa “Variations to purely national marketing authorisations” shall come into force on August 4th, 2013.

Information regarding the most significant amendments to the Regulation was provided on SAM website on July 19th, 2013. A procedure has been established for the worksharing procedure regarding medicinal products with purely national marketing authorisations in accordance with the updated Chapter 7, CMDh Best Practice Guide on Worksharing (Doc. Ref.: CMDh/297/2013/Rev.21 October 2013) of the CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure:

identical type IB or type II variations concerning medicinal products with purely national marketing authorisations can be grouped together in a single application and submitted as an application under worksharing;
if the medicinal products indicated in the application are authorised via national procedure in different countries, the Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMD-h) has to be notified before the submission of such an application so that the CMDh can appoint a reference member state and assign a variation procedure number;
if the medicinal products indicated in the application are authorised via national procedure in a single country, the competent authority of the relevant country has to be notified to approve the procedure and receive a procedure number;
if product information has to be changed as a result of the proposed changes, the relevant sections of the product information have to be indicated in English in the present/proposed section of the application for variations, but harmonisation of the whole product information is not necessary;
validation of application for variations and examination of variations is carried out by a reference member state approved by the CMDh in accordance with the time limits for type II variations laid down in Annex 2 and 5 of the aforementioned guidelines.

During the worksharing procedure the marketing authorisation holder shall not withdraw the medicinal product included in the application from medicinal product registers in any of the concerned member states. In that case these medicinal products shall be withdrawn from medicinal product registers in all of the concerned member states.

The full version of CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure, Chapter 7, CMDh Best Practice Guide on Worksharing (Doc. Ref.: CMDh/297/2013/Rev.21 October 2013) is available here