01/07 16:00 EBA Health Care Committee Registration Subcommittee
On 1 July 2008 the Healthcare Committee members met with Head of the State Pharmacological Center Viktor Chumak. Mr Chumak made a presentation highlighting a wide range of the healthcare sector problematic issues to be sorted out and also offered approaches to solution to various problems. Moreover, the meeting covered a number of issues Registration Subcommittee members were dealing with. Among other things the Committee representatives dwelt on SPC (Summary Product Characteristic) and instruction list coexistence; also they discussed the terms of expertise and signature of instructions. Answering the question Mr Chumak informed the attendees that one of possible variants to solve a problem was to edit a special healthcare reference containing all data on SPC of every medical drug registered in Ukraine. However, this initiative failed since it has never been put into practice before. He also stressed that according to the amendments to the Order No. 426 issued by the Ministry of Health on 26 August 2005, the SPC availability will be revised only by a producer’s consent. Producers of generic medical drugs shall be obliged to provide all the necessary information on every change made to the instruction list of the original product. As regards expertise terms, the participants were informed that the State Pharmacological Center would try to simplify the procedure by cancelling a three-phase expertise practice. Mr Chumak noted that a clear methodological regulation should be introduced to define prints and spacing between lines and also added that it is worth using universally millimetres instead of Dido points. However it takes more time and further amendments to the legislation. Also the attendees considered the AND problems (Analytical Norm Documentation). The relevant officials of the State Pharmacological Centre marked that the problem could be solved if the methods described in State Pharmacopeias were properly regulated and correlated. Otherwise, lack of common control methods may incur various difficulties. It was stated that companies need to submit the AND title list and specify their control methods as envisaged in the Order of the Ministry of Health No. 426 dated 26 August 2005. Registration Subcommittee members also studied the practice of parallel registration in Ukraine and in the EU. It was emphasised that it is actually possible following some real registration practice precedents. However the participants found such a procedure inconvenient since it requires a clinical test result.
General Membership Meeting with local authorities “Small and middle-scale business in crisis situation - EBA Dnipropetrovsk Branch
was held on Thursday, 20.11.2008 at 17:00.
