On legislative grounds, Art. 6 TPLRO* does not apply to fixed combinations of medicinal products approved under Art. 14, Para. 1, Letter abis TPA. For this reason, an application for the approval of a medicinal product pursuant to Art. 14, Para. 1, Letter abis TPA, which is not based on Art. 6 TPLRO cannot be rejected. Consequently, interpretation of the legal provisions would suggest that a combination of medicinal products, which fall under Art. 14, Para. 1, Letter abis TPA, no longer needs to be substantiated with documents as per Art. 6 TPLRO.
*) concerns amongst other things: clinical data, which demonstrate the efficacy and safety of the fixed combination compared to the individual components are required.
