For the first time the Republic of Bulgaria, as a Member State of the EU, will be the reference country in the decentralized procedure (DCP) for Marketing Authorisation for a medicinal products with applicant Tchaikapharma High Quality Medicines Inc., Bulgaria. The concerned parties in the procedure are Austria, Greece, Portugal, Romania, Slovakia and the Czech Republic.
As a reference party to the procedure the BDA will assess the dossier for Marketing Authorisation for medicinal products (fixed combination) with active ingredients ramipril and amlodipine. A team of the BDA will prepare evaluation reports, including questions to the applicant at any stage of the procedure. The evaluation will be consistent with the requirements of current Pharmacopoeia (Ph.Eur.), the Guidelines of the International Committee on Harmonization (ICH) and European guidelines on quality, safety and efficacy of medicinal products.