The Council of the Eurasian Economic Commission (EEC) has approved amendments to the requirements for instructions for the medical use of medicines and the general characterization of medicinal products (GCMP). Changes to the content of GCMPs are now allowed with the approval of authorized bodies of member states or the applicant, and the timeframe for making changes has been reduced from 180 to 120 working days.
According to the current version of the requirements, the general characteristics of medicines are placed in the unified register of registered medicines. It may also be placed on the official website of the authorized body of a member state of the Eurasian Economic Union (EAEU). The information in the GCMP must be clear and concise. Draft GCMPs and leaflet-insert (PI) should be submitted in PDF format with recognized text or in Word format.
In addition, there are new requirements for document formats and detailing of information in the sections of GCMPs. The updated document adds more detailed requirements for each section, including guidelines for the submission of information on dosage, dosage form, qualitative and quantitative composition, clinical data and other aspects.
Earlier, the EEC said that it does not plan to postpone the transition to a single market for medicines within the EAEU. However, it is planned to soften the conditions of transition in the member states of the Union. It was suggested that drug manufacturers should apply for scheduled inspections in advance to ensure uninterrupted supply of medicines.