Description

  • implementation of the procedure for issuance, amendment, and withdrawal of the manufacturing authorisation, wholesale distribution authorisation and authorisation for  retail sale of medicinal products in specialised shops,
  • implementation  of notification procedure for wholesalers who have acquired a licence for wholesale distribution authorisation in other EU member states.
  • the procedure of issuing a decision on a conformity assessment of conditions for manufacturing medicinal products and active pharmaceutical ingredients,
  • implementation of the procedure for entering, amending, and removing from the register of persons responsible for the release of medicinal products, 
  • implementation of the procedure for entering, amending, and removing from the register of manufacturers wholsalers and importers of active substances.
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