The marketing authorisation holder of a medicinal product which does not comply with the requirements of the Regulation on protective elements after completion of manufacture may apply to the Ministry of Health for a temporary authorisation for the distribution and dispensing of such medicinal product. The Ministry of Health shall issue a temporary authorisation in order to ensure the availability of medicinal products.

The doctor is obliged to inform the State Institute for Drug Control about the use or prescription of an unregistered medicinal product.

A distributor of medicinal products who has not yet been granted a certificate of good distribution practice on the basis of an inspection carried out by the State Institute for Drug Control may apply for such a certificate. If the distributor already holds a certificate and there have been changes to the information on it (e.g. change of registered office address, name of the entity), it may apply for a modified certificate in a similar way.

Application for a certificate of good laboratory practice. Legal entities or natural persons authorized to conduct business may conduct non-clinical drug safety studies only if they hold a certificate of good laboratory practice issued by the State Institute for Drug Control.

The State Institute for Drug Control shall issue, upon application, a certificate of good clinical practice, which is a certificate that the health service provider meets the conditions of good clinical practice in its activities.