News

21 Feb

Posted at 15:24h in News

Agency for Medicinal Products and Medical Devices of Croatia (HALMED) had successfully fulfilled all conditions within the evaluation conducted by the Canadian regulatory body Health Canada with the purpose of implementation of the Mutual Recognition Agreement with Canada (EC-Canada MRA) in the area of conformity of good manufacturing practice (GMP) programs. The operational phase of the agreement begins on 1...

21 Feb

Posted at 15:22h in News

Agency for Medicinal Products and Medical Devices of Croatia HALMED) has been officially confirmed as a member of international organisation Pharmaceutical Inspection and Co-operation Scheme (PIC/S). HALMED's membership had been approved by the PIC/S Secretariat in October 2015 and will formally begin on 1 January 2016. This important achievement confirmed once again the exceptional competence of HALMED's employees who enabled HALMED's...

21 Feb

Posted at 15:19h in 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...

08 Jan

Posted at 19:08h in News

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...

08 Jan

Posted at 19:06h in News

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...

19 Sep

Posted at 12:15h in News

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...

19 Sep

Posted at 12:12h in News

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...

19 Sep

Posted at 12:11h in News

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...

19 Sep

Posted at 12:09h in News

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...