Manufacture of pharmaceuticals, medical devices, and cosmetics
We provide comprehensive legal counsel and representation in obtaining necessary permits, registrations, and authorizations for the manufacture, research, import, and placing on the market of pharmaceuticals, medical devices, and cosmetic products.
We most frequently assist clients with:
- representation in proceedings for the issuance of manufacturing or wholesale distribution authorizations for pharmaceuticals before the State Institute for Drug Control (ŠÚKL),
- obtaining Good Manufacturing Practice (GMP) certificates for manufacturers of pharmaceuticals and active substances,
- approval of cosmetics manufacturing and packaging premises by Regional Public Health Authorities (RÚVZ) and assessment of compliance with Good Manufacturing Practice for cosmetics,
- registration and notification obligations for cosmetic products via the European Cosmetic Products Notification Portal (CPNP) prior to market entry,
- legal representation in the registration of medical devices in the EUDAMED database and with ŠÚKL,
- representation in permitting procedures for importing pharmaceuticals, active substances, and cosmetics from third countries (outside the EU),
- additional permitting, registration, and administrative steps before ŠÚKL, the Ministry of Health of the Slovak Republic, and the Public Health Authority of the Slovak Republic (ÚVZ SR) required to legally launch and operate production.
Should you be interested in our legal services, please feel free to contact us at info@akvlkova.sk or by phone at +421 949 203 288.