Please be informed that the updated Instruction – Manner of submitting application and documentation for the renewal of marketing authorisation for medicines for human use has been published on CInMED portal in the section Human medicine/Placing a medicine on the market, along with the Application for the renewal of marketing authorisation for a medicine and Cover letter – issuance of the renewal of marketing authorisation for a medicine. The Instruction in question provide information on the manner and type of required documentation to be submitted to CInMED along with the application for the renewal of marketing authorization for a medicine, as well as other information.

Application and cover letter forms have been also published in the section Veterinary medicines/Placing a medicine on the market.

Please follow updated Instruction and use relevant forms when preparing and submitting the documentation.