The Institute for Medicines and Medical Devices of Montenegro (hereinafter: CInMED) informs applicants and marketing authorisation holders that, following the adoption of the new Law on Medicines, updated forms have been published on the CInMED portal under the section Human Medicines / Placing a medicine on the market / Instructions and Forms:

• Cover letter – issuance of marketing authorisation for a human medicine
• Notification on placing a medicine on the market
• Notification form

All stakeholders are kindly requested to adhere to the updated forms when preparing and submitting documentation and to use exclusively the new forms going forward.

Marketing authorisation holders are reminded that, in accordance with the Law on Medicines, they are required to submit the Notification on placing a medicine on the market in a timely manner and using the designated form.