We announce the applicants that the Commission Regulation (EC) No. 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products enters applies from January 1st, 2010. The said Regulation amends previous Regulations No. 1084/2003 and 1085/2003.
The State institute for drug control will apply the provisions of the said Regulation for all types of procedures from January 1st, 2010.
The SIDC gives the following information to make clear the procedure of administration of in-process Applications for variations in the eApplication system before December 31st, 2009 and after this date:
1. All Applications semi-finished by the applicants for MA and by the applicants for variations in the MA till December 31st, 2009 will be administered according to up the date valid Regulations in the case they fulfil valid requirements (the applicant filled-in the eApplication and the system allowed to print out the Confirmation on data validity in the eApplication system).
2. All Applications for MA and for variations in the MA semi-finished by the applicants till December 31st, 2009 which, however, do not fulfil the criteria valid till December 31st, 2009 (the system did not allow to print out the Confirmation on data validity - due to missing data or documents) must be newly processed by the applicants in the eApplication system according to are obliged to the Commission Regulation (EC) No. 1234/2008 coming to force from January 1st, 2010.
3. All applications submitted to the SIDC after December 31st, 2009 should be processed in the new eApplication system according to the Commission Regulation (EC) No. 1234/2008 coming to force from January 1st, 2010.
Concurrently new documents are put into practice from January 1st, 2010:
This practically means that the applicants for MA and the applicants for variations in the MA fill-in the Applications according to new method in the system eApplication from January 1st, 2010.
In the case of questions, contact us at: evar@sukl.sk.
Bratislava, December 31st ,2009, Department of Registration, State Institute for Drug Control
