Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.
Pharmaceutical Establishment License
Pharmaceutical Establishment Licensing ensures a comprehensive risk management process, a consistent approach to GMP, and to a certain extent a uniform licensing framework across regulated markets – for the manufacturing, importation and/or wholesale of medicinal products.
PEL in Switzerland:
Applicants for MAA in Switzerland must be locally based and must hold a Pharmaceutical Establishment License from Swissmedic, in order to file a MAA. A PEL is required for both (i) companies headquartered or affiliated in Switzerland, and (ii) companies based outside the country that apply for MAA in Switzerland (often applying for EU MAA, and willing to extend it to Switzerland).
The delivery of an establishment license is based on the development of a Quality Assurance and Quality Management System (QMS), and subject to a pre-approval inspection from Swissmedic. A Swiss-based Qualified Person (QP) responsible for setting up and maintaining the QMS is necessary. The QP is ultimately also responsible for batch release of products to be commercialized onto the Swiss market. Distinct types of establishment licenses specifically condition the manufacturing, importation and/or wholesale of:
Biological and chemical medicinal product;
Advanced Therapy Medicinal Products (i.e. Cell, Gene and Tissue Therapies).