Imports of active substances
The importation of active ingredients may be performed by business entities entered in the registry of importers of active ingredients which hold a permit for the production of medicinal products, producers of active ingredients and wholesalers of active ingredients (Here in after referred to as: An importer of active ingredients)
An importer of active ingredients may only import active ingredients which are:
- produced in accordance with the guidelines and principles of good production practice for active ingredients applied in the European Union or
- the guidelines and principles of good production practice for active ingredients applied in a third country which are equivalent in terms of requirements to those determined by the European Union.
An importer of active ingredients which imports active ingredients intended for the production of medicinal products for human use may only import active ingredients accompanied by a written certificate from the competent authority from the third country stating that:
- that the standards of good production practice which are used at the location where the imported active ingredient is produced are at least equivalent to those determined by the European Union;
- that the production facility is regularly supervised by the competent authority and that
- the European Union Member States where the active ingredients are imported will be notified immediately in the event of non-compliance with the standards of good production practice.
It is not necessary to present the written certificate referred to in the previous paragraph if the third country in question is on the list of countries kept by the European Commission where the requirements and standards of good production practice are equivalent to those in the European Union.
Conditions and evidence
- Entry in the register of importers of substances Informing about counterfeits or suspected counterfeiting of substances Verification of the suitability of providers of substances Compulsory management of information on merchandise Establishment of working hours Minimum technical conditions in specially arranged room in a wholesale outlet Regular certification of metering devices
- Medicinal Products Act
- Rules on detailed conditions of wholesale of medicinal products and determining of fulfilment of these conditions and procedure of gain the permission for traffic of wholesale of medicinal products
- Trade Act
- Metrology Act
- Rules on minimum tehnical requirements for performing the trade activity