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Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products

This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment licence for medicinal products or TpP/GT/GMOs".

Swissmedic, places a strong emphasis on ensuring that all manufacturers, including foreign manufacturers, comply with Good Manufacturing Practice (GMP) standards. This compliance is crucial for ensuring the quality, safety, and efficacy of therapeutic products. Swissmedic provides detailed guidance on the requirements for foreign manufacturers seeking to obtain GMP compliance for the manufacturing of therapeutic products.

This guidance document clarifies which documents should be submitted as part of an authorisation application (new application) - which are minor type IA/IAIN variations that can be notified after the event, which are minor type IB variations that must be notified in advance, and which are major type II variations for a product that has already been authorised, or for a new application. Authorisation holders or applicants for the authorisation of ready-to-use medicines produced abroad and/or in Switzerland and containing foreign active pharmaceutical ingredients are invited to read this information sheet.

By following this guidance and demonstrating compliance with GMP standards, foreign manufacturers can ensure that their products are accepted in the Swiss market and contribute to the health and well-being of Swiss patients.

Swissmedic plays a crucial role in ensuring the quality, safety, and efficacy of medicinal products, as well as therapeutic products of human or animal origin (TpP), gene therapy products (GT), and genetically modified organisms (GMO). One key requirement for manufacturers and importers of these products is obtaining an establishment licence from Swissmedic.

This licence is essential for demonstrating compliance with Swiss regulatory requirements. Swissmedic provides detailed guidance on the application process for obtaining an establishment licence. The establishment licence demonstrates that a manufacturing or importation facility meets the necessary standards for producing and handling medicinal products, TpP, GT, or GMO.

The establishment licence covers various aspects, including the facility's premises, equipment, personnel, and quality management system and the establishment licence is a prerequisite for obtaining marketing authorisations for medicinal products, TpP, GT, or GMO in Switzerland.

Click this LINK to know more about the regulatory requirements, to ensure the successful application and issuance of an establishment licence.


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