Food & Beverages Regulation Report, Chile

This report provides information on regulations imposed on Food & Beverages in chile for Product registration, Import, submission, renewal, variations, local agent requirement, labeling, Claims and Advertising, Contaminants control & Warehousing.

Comments

Post a Comment

Popular posts from this blog

Medical Device Regulation Report, Morocco, Registration

This report provides information on regulations imposed on medical device in Morocco for product registration, import permit, validity & renewal process, variations filing, legal representative and labeling. Summary Product definition and governing regulations; Information on medical device registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Medical Device Regulation Report, Morocco, Registration
Read more

6 Key Challenges in South Korea’s Pharma Regulations & Solutions

  South Korea is a rapidly growing pharmaceutical market with a well-established regulatory framework governed by the Ministry of Food and Drug Safety (MFDS). However, foreign pharmaceutical companies often face complex MFDS regulations when entering the market. Understanding these challenges and developing a strong regulatory submission strategy is essential for successful market entry. Here are six key regulatory challenges and strategies to overcome them: 1. Registration of Overseas Manufacturing Facilities  Foreign manufacturers must register their facilities with the MFDS before import declaration. This process involves strict compliance with MFDS regulations, detailed documentation, and adherence to Good Manufacturing Practices (GMP). How to Overcome It: Ensure early registration through the MFDS online platform. Maintain comprehensive documentation to meet MFDS regulatory submission requirements. Collaborate with local regulatory experts to streamline the submission pro...
Read more

Sister File Procedure, Certification of Suitability, CEP Submission, Renewal

Freyr Regulatory team helps API manufacturers in sister CEP filing , compilation, review and submission to EDQM for all types of APIs/drug substances as per EDQM guidelines and requirements. A certification of Suitability (CEP) holder, who wishes to possess a second CEP for the same Active Pharmaceutical Ingredient (API)/drug substance, can file a new application referred as a “Sister file”. It can be due to differences in API specification obtained with alternate process or to cover alternate grade of material. This is valid for all files except sterile, TSE or herbal applications. A Sister CEP to the approved CEP filed with European Directorate for the Quality of Medicines and Health Care (EDQM), must be approved on a fast track basis compared to the approval timelines of original CEP applications.  There are pre-defined conditions set by the EDQM that must be fulfilled in order to file the sister CEP. Hence, expertise is required to file the sister CEP with the EDQM for qu...
Read more