Senior Partner, Legal Alliance Company, Dmytro Aleshko held a seminar “Practice of resolution of issues in connection with incompliance of the font used on package and package insert of pharmaceuticals with the requirements of the Ministry of Health
February 2 this year, Legal Alliance Company together with the Association of Manufacturers of Innovative Pharmaceuticals held the seminar having the subject as follows: “Practice of resolution of issues in connection with incompliance of the font used on package and package insert of pharmaceuticals with the requirements of the Ministry of Health Care of Ukraine”.
Pursuant to Clause 4.1, Procedure for prohibition (suspension) and withdrawal from circulation of pharmaceuticals in the territory of Ukraine as approved by Order No. 497 of the Ministry of Health Care of Ukraine of 12 December 2001, incompliance of pharmaceuticals with the requirements stipulated in regulatory documents creates the grounds for temporary prohibition (suspension) of circulation of such pharmaceuticals.
One of such incompliances may be incompliance of the font used on package and package insert with the requirements set forth in Order No. 426 of the Ministry of Health Care of Ukraine of 26 August 2005.
The temporary prohibition may be imposed by both the State Inspectorate for Supervision over Pharmaceuticals Quality and the regional subdivisions thereof. The control of the font size shall be carried out by relevant inspectorates at the time of import of pharmaceuticals in Ukraine.
At the same time, taking into account the fact the font size used in the package poses no damage for human health and life, the State Inspectorate for Supervision over Pharmaceuticals Quality may permit sales of a pharmaceutical having inappropriate font size.
At the event Senior Partner, Legal Alliance Company, Dmytro Aleshko shared with the participants his experience in this area. The participants heard clarifications about the procedure for preparation and delivery of documents necessary to obtain relevant permits from the Inspectorate.
The seminar participants had an opportunity to ask questions related to the government control over the pharmaceuticals’ quality and compliance of drugs with the requirements set forth in the regulatory documents.
