(MAH)
| Market authorization holder (MAH) : Any legal entity that holds marketing authorization by the country-designated body or organization to distribute and sell its pharmaceutical products in a given country. In Switzerland, the Market Authorization Holder (MAH) is the legal entity responsible for holding the marketing authorization granted by Swissmedic, the national regulatory authority. The MAH has the legal right to distribute and sell a pharmaceutical product on the Swiss market and is ultimately accountable for the product’s compliance with all regulatory, quality, safety, and pharmacovigilance requirements. The MAH can be a pharmaceutical company, an importer, or a local representative, provided they meet all the regulatory obligations defined by Swiss law.The MAH must ensure that the product information, labeling, manufacturing, distribution, and monitoring comply with Swissmedic’s standards throughout the product’s lifecycle. They are also the primary contact for authorities in the event of recalls, adverse event reporting, or regulatory inspections. |
