The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) hereby informs all marketing authorisation holders for medicinal products for human use of the following:

The application form for the submission of variations has been updated on the official website of the Institute. A new section, E.6 – Changes to the approved labelling of a medicinal product with no impact on the quality, safety or efficacy of the medicinal product, has been introduced within the form. This section refers to the following changes:

• introduction of additional labelling (medicinal product packaging) for placing on the market in Montenegro;
• replacement of already approved labelling (medicinal product packaging);
• deletion of approved labelling (medicinal product packaging), provided that an alternative labelling (packaging) has already been approved;
• addition or deletion of an EAN code.

Please note that, in the case of addition or replacement of approved packaging, the above-mentioned changes may apply exclusively to packaging that has already been approved:

• in one of the Member States of the European Union, or
• in countries of the region.

The variation type E.6, as defined in the new application form, corresponds to the variation type B.II.e z – Changes to the packaging (“container closure system”) of a medicinal product – other variations, as defined in the previous application form.

All details regarding the submission of applications, required documentation and applicable timelines are available on the official website of the Institute or may be obtained directly via the contact details published on the website.