Application of Art. 13 TPA for temporary authorisation according to Art. 9a TPA was previously only possible for new authorisations of human medicinal products with a new active substance. Subject to certain conditions, assessment is now also possible in application of Art. 13 TPA for temporary additional indications for human medicinal products with a new active substance as well as for human medicinal products with a known active substance where an application is being made for an indication that has not previously been authorised.
The guidance document Authorisation of human medicinal products under Art. 13 TPA has been updated accordingly. Aspects of the document Questions and answers Art. 13 TPA have also been incorporated into the guidance document Authorisation of human medicinal products under Art. 13 TPA.
The updated guidance document Authorisation of human medicinal products under Art. 13 TPA is valid with immediate effect.