On 6 May, Medical Procurement of Ukraine held a webinar dedicated to ensuring the quality and safety of medical devices after their procurement and transfer to healthcare institutions. The event was supported by the USAID project “Safe, Affordable and Effective Medicines for Ukrainians”, SAFEMed, and brought together representatives of Medical Procurement of Ukraine, the State […]
Cancellation of automatic renewals and change in validity periods of marketing authorisations for certain medicinal products
On 1 June, Resolution of the Cabinet of Ministers of Ukraine No. 377 entered into force. The Resolution abolishes the automatic extension of the validity period of marketing authorisations during martial law and provides for the extension of the validity period of marketing authorisations issued under the emergency registration and authenticity procedures for procurement by a specialised procurement organisation.
As of 1 June, the automatic extension of the validity period of marketing authorisations for medicinal products for the following year has been cancelled, and MAH’s have six months to submit an Application for renewal. We would like to remind you that, as a general rule, an Application for renewal of a medicinal product must be submitted no later than 180 calendar days before the expiry of the marketing authorisation. This applies to medicinal products with marketing authorisations of limited validity, registered under the standard procedure in accordance with Order of the Ministry of Health of Ukraine No. 426 and under the recognition procedure in accordance with Order of the Ministry of Health of Ukraine No. 1245.
The Resolution provides for the extension until 1 January 2028 of the validity period of marketing authorisations for certain categories of medicinal products, in particular:
- medicinal products procured by the person authorised to conduct procurement in the healthcare sector, in accordance with MoH Order No. 1391;
- medicinal products, vaccines and other medical immunobiological products for the treatment and/or specific prophylaxis of COVID-19, registered under obligations for emergency medical use, in accordance with CMU Resolution No. 1446;
- medicinal products, medical immunobiological products and blood products registered under the emergency state registration procedure for the period of martial law under obligations, in accordance with MoH Order No. 384.
Please note that, in connection with the entry into effect of the new Law of Ukraine “On Medicinal Products” on 1 January 2027, the above extension until 1 January 2028 may be regarded as a transitional mechanism for the relevant categories of medicinal products, and such automatic extension may be the final one. To maintain market access for such medicinal products, we recommend assessing the further regulatory strategy in advance.
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