“Variation workshop in Zagreb”
In collaboration with HALMED and the Croatian Pharmaceutical Industry, in Zagreb on 4th and 5th May 2017., was held two-day workshop entitled “Variation Workshop”.
The EU variation regulation went through a major revision in 2008 and was further amended in 2012. Now, almost 10 years later it can still be difficult for
authorities and industry to have a common interpretation of the regulation. This workshop addressed a number of the questions that marketing authorization holders (MAHs) may have on variation procedures and provide an overview of the EU legislation concerning the different types of variations.
The main focus was on the variation guideline, how to classify a variation according to the guideline, how and when to submit a variation and finally how to implement changes. Moreover, there was a session on work-sharing and grouping as well as on when to use these submission pathways. Meeting Croatian and other National European Authorities and Industry Leaders The workshop was having lecturers from different European authorities such as
HALMED/Croatia and BfArM/Germany as well as the industry, and it was discussion regarding challenges seen both from the perspectives of authorities and industry. We mainly cover submissions via the MRP/DCP and national procedure.
What Regulation and Guidelines were Covered?
The workshop took its off-spring in Regulation 1234/2008, amended with Regulation 712/2012 as the legal basis and also the guidelines on the Details of the Various Categories of Variations, on the Operation of the Procedures Laid Down in Chapters II, IIa, III and IV of 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 and on the Documentation to be Submitted Pursuant to Those Procedures.
The conference was held in Zagreb on 04th and 05th May 2017.
Clinres attended this conference.