07.11.2011
To the attention of interested persons
In accordance with Article 729 and Article 730 of Law 95/2006 on healthcare reform, Title XVII – The medicinal product, Marketing Authorisation Holders are required to forward to the National Agency for Medicines and Medical Devices updated information concerning placement on the market status (date of recall) of all medicinal products with valid authorisations included in their portfolio, within 15 days from the date of this notification.
Information is to be submitted in electronic format (e-mail address: cristian.sandulescu@anm.ro) and on paper, in accordance with the form for reporting of marketing authorisation status (Article 729 of Law 95/2006).
National Agency for Medicines and Medical Devices of Romania
