подача заявлений на первичную государственную регистрацию(термин не мой: This RMP section should contain the initial identification of safety concerns and is expected to be populated with the initial submission of an RMP, either at the time of the initial marketing authorisation application or post-authorisation.
SEtrans)
заявление на выдачу регистрационного удостоверения(Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking permission to bring a newly developed medicinal product (for example, a new medicine) to the market. MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the Committee for Medicinal Products for Human Use of the European Commission. In the United States, the equivalent process is called New Drug Application. WK Alexander Demidov)
