The simplified registration procedure for medicines registered in countries with a strict regulatory system stipulated by the Ministry of Health’s order No. 1245 of 2016 is not effective, according to the Indian Pharmaceutical Manufacturers Association (IPMA).
“The simplified procedure stipulated for registration of drugs registered in countries with strict regulatory systems has recently been ineffective, and applicants have had rejections on formal grounds,” the IPMA said.
According to the association, in particular, based on the conclusion of the State Expert Center (SEC), the Ministry of Health appointed a meeting of the Commission on Problematic Issues, where a collegial decision regarding registration was taken, but since February 2022, there was no commission. At the end of 2022, orders were still signed on state registration of medicines registered by the competent authorities of the USA, Switzerland, Australia, Canada, and the EU. At the same time, on February 10, 2023, the Ministry of Health signed an order to refuse state registration of 34 foreign-made drugs.
“We believe that a simplified procedure would work more effectively if the work of the Ministry of Health Commission on Problematic Issues was resumed. The refusal to register 34 medicines of leading foreign manufacturers due to problems in the interpretation of the legislation and on formal grounds is discriminatory and harms the welfare and health of the Ukrainian people in wartime”, the IPMA noted.
The association believes that the order of February 10, 2023, which denied registration of 34 medicinal products registered in countries with strict regulatory systems, should be canceled, and the applicants that were denied registration should have the opportunity to justify the grounds for registration and confirm compliance with legislation.
The IPMA noted that the reason for refusing to register medicinal products, whose applicants are IPMA member companies, could be inconsistencies caused in part by legal requirements and peculiarities of registration in Ukraine.
“We are talking about the first registration of Indian medicinal products whose applicants are members of our Association. These are new high quality medicinal products that have already been evaluated by the competent authorities of the USA, Switzerland, Japan, Australia and Canada and according to the centralized procedure registered by the EU competent authority”, – the IPMA informed.
The association notes that not all analogs of drugs whose registration was denied are currently on the market, but there are new drugs on the list.
“For example, the medicines of one applicant (Zandra Life Sciences Private Limited) submitted for registration under this procedure are new generic medicines that have no analogues in Ukraine, but have already been successfully registered and used in the USA. Their registration in Ukraine will allow Ukrainian patients to use them for treatment”, the IPMA noted.
Earlier Teva-Ukraine also said that the procedure for simplified registration of drugs registered in countries with a strict regulatory system was not perfect initially, but since the beginning of the armed aggression its shortcomings have deepened. According to her data, from 2016 to 2022, the company registered 10 drugs in Ukraine under the simplified procedure and received two refusals, and the last such registration in 2022 lasted 203 days while the standard procedure required 210 days.
As reported, on February 10, the Ministry of Health of Ukraine refused to register 19 foreign medicinal products under the simplified procedure. These drugs were registered in the countries by the competent authorities of the USA, Switzerland, Japan, Australia, Canada and the EU competent authority. In particular, the Ministry of Healthcare refused to register five drugs produced by Teva-Ukraine, nine drugs produced in India, in particular by Glenmark Pharmaceuticals, McLeods Pharmaceuticals and Zandra Life, five drugs from the Turkish company DEVA, as well as drugs from the British company Reckitt Benckiser Healthcare and Pfizer.
The simplified procedure was approved by Order No. 1245 of the Ministry of Health in November 2016. According to which drugs registered in countries with strict regulatory policies – Japan, Switzerland, USA, Canada, Australia, EU countries can be registered in Ukraine under a shortened procedure within 10, 17 or 45 days – depending on the category of registered drugs.
In May 2018, the Ministry of Health initiated the expansion of the list of documents that are provided for the examination of the authenticity of registration materials for drugs (registered in other countries), which are submitted in Ukraine for state registration for the purpose of their procurement by international organizations.
