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Manufacture of pharmaceutical preparations (21.200)

This SCA code includes activities and services for which entrance and/or other conditions for the commencement and pursue of an activity are established. 


Regulations and conditions:


  •  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.
Source: Ministry of Economic Development and Technology
  • 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:

Source: Ministry of Health


Activities/services which are classified in this sub-class of the standard classification of activities:


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.
Source: Statistical Office of the Republic of Slovenia – Explanatory notes to the standard classification of activities – SKD 2008.pdf (1.8 MB)

Applies for SKD:

  • Manufacture of pharmaceutical preparations C21.200