Mock-up of medicinal product packaging
The Instructions for preparing a mock-up of medicinal product packaging (version 1.3, January 2026) are available here.
These instructions are intended for applicants/marketing authorisation holders as guidance for preparing a mock-up of medicinal product packaging, in order to make optimal use of the available packaging surface for including the required mandatory information. This ensures the unambiguous identification of medicinal products and their safe administration.
The instructions explain the provisions of the applicable legislation concerning the labelling of medicinal products and provide more detailed recommendations for preparing a high-quality and consistent presentation of information on mock-ups of medicinal product packaging, which must be clear and legible in order to avoid confusing healthcare professionals and users of medicinal products, and to prevent the possibility of medication errors.
Version 1.3 of the instructions has not been substantively amended in comparison to Version 1.2. The revision serves primarily to provide clearer instructions regarding the indication on the mock-up of the packaging of medicinal product "not subject to medical prescription”. Additionally, updates have been made to align references to legislative acts following amendments to the Medicinal Products Act (Official Gazette, Nos. 76/13, 90/14, 100/18 and 136/25), the Trademarks Act (Official Gazette No. 14/19), and the Ordinance on the Granting of Marketing Authorisation for Medicinal Products (Official Gazette, Nos. 83/13, 28/20 and 32/21).
