Manufacture of pharmaceutical preparations (21.200)

•  List of activities usually carried out as a craft

For activities listed on the List of activities usually carried out as a craft, business entities registering these activities must also enter in the register
of crafts at the Chamber of Craft and Small Business of Slovenia (OZS) ex officio.

This applies for the following activities/services:

• preparation of botanical products and other substances for pharmaceutical use.

• Medicinal products act

A business entity may produce medicinal products only on the basis of, and in accordance with a permit for, the production of such products.

The permit must be obtained for individual production facility, individual production activities, individual pharmaceutical forms and import of medical products from third countries.

The procedure for obtaining the permit begins on
the basis of an application of a business entity seated in the Republic of Slovenia. Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) issues or refuses to issue a permit for the production of medical products within 90 days from the reception of a complete application on the basis of an opinion of the expert commission for establishing the fulfilment of the conditions for the production of medicaments.

More detailed information on the conditions for the exercise of the activities:

• Manufacture of medicaments;
• Non-routine production of advanced therapy medicinal products.

This class includes:

• manufacture of medicaments:
• antisera and other blood fractions, vaccines, diverse medicaments and homeopathic preparations;
• manufacture of chemical contraceptive products and hormonal contraceptive medicaments;
• manufacture of medical diagnostic preparations, including pregnancy tests;
• manufacture of radioactive in-vivo diagnostic substances;
• manufacture of biotech pharmaceuticals.

This class also includes:

• manufacture of medical impregnated wadding, gauze, bandages, dressings, etc.;
• preparation of botanical products for pharmaceutical use.