News

Legal basis in HR The sunset clause is applied under the provision of the Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14) in HR.  According to this Act, if a medicinal product has not been placed on the market in the Republic of Croatia for three years since the date of the granting of a marketing...

The EDQM has organised a Webinar for January 17th on elemental impurities to assess the impact of the implementation of ICH guideline Q3D, which is applicable for new marketing authorisations since June 2016, on the texts of the European Pharmacopoeia and on the assessment of CEP applications.  More info available here. The eCTD specifications of EU Module 1 changed to version...

The 10th Italian National Meeting of Qualified Persons, promoted by a trade association, took place in Rome on the 25th November, 2016. One of the topics discussed during the meeting was the data integrity.  The Italian Medicine Agency (AIFA) defined this as a key element within their inspections.  In fact, many Italian manufacturing sites are also authorised by the US FDA...

This quarter marks the breakthrough of data-integrity as a new, important element of GMP-systems worldwide. While the MHRA already issued its Guidance for Industry in March 2015, in April 2016 the FDA issued a similar guideline. So we will have to prepare ourselves for this theme to arrive on the table during GMP-audits. For that reason, we will have to...

Jan 2016 – CESP submission is accepted for HU in the case of new marketing authorisation applications for human medicinal products (in either eCTD or NeeS) for MRP/DCP and national applications only. Jan 2016 – eAF is mandatory in case of registration, variation and renewal.  In addition a paper copy is still required if eAF does not contain e-signature 13 June 2016...

February 2016 (not added on our website yet) : EU Module 1 eCTD specifications changed to version 3.0.1, and are in force since July 1st, 2016. eCTD validation criteria also changed to version 6.1, to be in line with the updated EU M1. Medipha Santé will be attending the CPhI congress 2016, which will take place in Barcelona from October 4th...

The new decree (210/1016) on fees chargeable by Fimea entered into force on 1 April 2016. Most notably, there are no increases in fees.  In addition, the pharmacy dispensary licence fee and the following type IB variation application fees have decreased. Human medicines, type IB variations National type IB variation fee decreased from EUR 500 to EUR 450. Finland, CMS...

EuDRAcon is pleased to announce the launch of its new and improved website. Covering 28 Member States, EuDRAcon is a network of highly professional and experienced regulatory affairs specialists, with experience in all aspects of drug development, from cradle to grave.  We can advise you on those tricky national issues as well as all aspects of drug quality, safety and efficacy...