To the attention of all distributors of medicinal products
Given the entry into force of Order of the Minister of Health no. 269/2017, referring to implementation of Article 5 on wholesale distributors’ obligation to notify the NAMMD 10 working days prior to performance of an intracommunity delivery, please be advised that the notification mentioned in the Annex to the Order shall be submitted to the NAMMD in both electronic format and on paper, accompanied by a summary of the notified information, in Excel, which shall contain the following columns: Distributor, trade name (according to the MA), INN, pharmaceutical form, strength, packaging size, CIM code, ATC code, MAH name, batch, notified quantity, supplier, country of distribution, supply on date of notification (notified quantity excluded), date of notification, monthly average turnover/product (see attachment).
The summary in Excel shall also be forwarded by e-mail at raportaremedicamente@anm.ro, mentioning the notification’s registration number at the NAMMD Registry.
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