Re-registration of the company’s products under the new procedure

On 14 April 2022, the product registration department of PIQ-PHARMA received the first marketing authorizationcertificate in accordance with the new Eurasian Economic Union (EEU) requirements.

Elcar® effervescent granules 1000 mg manufactured by E-PHARMA, Italy, which had previously been registered under the national procedure now is the first of all PIQ-Pharma portfolio having dossier in a new format.

Registration dossier comprising 226 documents was submitted on October 4, 2021, and on March 05, 2022 a new registration certificate LP-N (000613) -(RG-RU)-050322 with period of validity of 5 years was issued allowing the sales of Elcar® effervescent granules in the Russian Federation.

Registration dossiers for all medicinal products registered in the Russian Federation must be brought in compliance with the requirements of international treaties and acts constituting Union law by December 31, 2025, in accordance with the EEC Decision "On the rules for registration and review of medicinal products for medical use".

The Registration Department of PIQ-Pharma has drawn up a plan to bring the dossier into compliance and the work is progressing according to plan. To date, the Ministry of Health has submitted dossiers under the above procedure for 2 more medicinal products and the remaining dossiers are in preparation.