Regulatory requirements and Current Challeges related to Related to Labling and Packaging for Medicinal Products in Europe Region

Abstract

The Common Technical Document format was developed by the ICH to streamline the inconsistency of submission requirement in the Different Countries. There are idelines for basic information for labeling and packaging to prepare mock ups. Packaging and labeling serve information directly to the patients and therefore required to be updated in stipulated time, to meet the compliance and to minimize the query and to mitigate risk to the consumer due to substandard medicine. According to the labeling there are three elements of the Medicinal Product label: Summary of product characteristics (SmPC) and Patient Information Leaflet (PIL), Outer/Immediate label. The Summary of product characteristics, Labeling and packaging leaflet are located in Module 1. Labeling is the most crucial factor to determine the safety of the medicine. For the purpose of safety and efficacy of the product, the medicinal product has been evaluated by the respective regulatory authority of the country. Medicinal product may be approved, if application found suitable by the agency. Prior to marketing a medicinal product in the EU, a marketing authorisation (product licence) is must. There are so many updates in labeling rather minor or major, that changes should be updated with in timeline suggested by EU authority and according to guidelines. Thus, the variation filing is must to regulatory authority according to the changes and types of variation. Patient detects the information on label but as additional requirement on label in different countries in Europe region that called Blue box requirement. As mention in article 57 and 62 of directive 2004/83/EC. Blue box requirement contains information like legal status, symbols and pictogram and identification and authenticity on label for medicinal products. Europe faces the current challenges related pack and label that ate to meet the labeling compliance and to minimize the risk of market complaints which affected by the identification, readability and dispensing perspective. Compilation to EUFMD along with the regulatory compliance and confirm with supply chain in a scenario of Brexit. Europe has been concerned about the growing threat of falsified medicine to the purpose of patient health and safety. Falsified medicine directive regulation is passed by European union parliament, with the main concern is to increase the patient safety and to prevent falsified medicine from entering the supply chain. To improve the patient safety and security, there are main three key omponents are involved in FMD. Manufacturer should comply with EUFMD before February 2019 to export and distribute medicinal product in Europe Region.