With the publication of Delegated Regulation 2022/2239, the European Commission has released the revised and amended labelling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation (CTR). This eliminates the need to retroactively label the expiration date on the primary packaging of unapproved investigational products for which new stability and shelf-life data become available over time.
A new label was previously required and applied to both inner and outer packaging. This laborious process in turn posed a risk to the safety and quality of the preparation. One such potential risk may be damages stemming from the need to open the packaging by breaking tamper evident seals and disassembling the multilayer kit. Another potential risk may be prolonged exposure to light or higher temperatures for medicinal products with specific sensitivities. Those risks apply to medicinal products where the immediate and outer packaging are provided together as well as when the immediate packaging takes the form of blister packs or small unit. Given the nature and extent of the risk, the Commission considers it appropriate and proportionate that the period of use is omitted from the immediate packaging.
Annex VI to Regulation (EU) No 536/2014 is amended in accordance with the Annex to Regulation 2022/2239. The Regulation shall be binding and applicable in all European Member States as of 5th of December 2022.
