The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) hereby informs all marketing authorisation holders of medicinal products for human use that the following documents have been published on the Institute’s portal, under the section Human Medicines / Placing a medicine on the market / Instructions and Forms:
- the updated application form,
- Annex 1 to the application form, as well as
- the updated guidance on the submission of applications and documentation for variations.
The updated application form includes the additional variation type z) other variations, while the updated guidance prescribes the obligation to submit Annex 1, with the fulfilled conditions for the proposed variation classification clearly indicated, as well as the supporting documentation.
The guidance also includes additional instructions for handling unforeseen variations, the removal of information from the common SmPC and PIL texts for medicinal products whose marketing authorisation has ceased to be valid, as well as the procedure for reporting the addition or deletion of the EAN code.
The Institute invites its users to familiarise themselves with these changes in a timely manner and to comply with the updated form and Gguidance when preparing and submitting documentation.
All details regarding the submission of applications, required documentation and timelines can be found on the official portal of the Institute or obtained directly through the contact details available on the portal.
