28.06.2012
To the attention of Marketing Authorisation Holders
On Monday, 23.07.2012, the NAMMD organises a meeting with MAH representatives (members of the Romanian Association of Medical Product Suppliers) and MAH representatives OUTSIDE professional associations. THE NAMMD suggests that persons involved in activities related to regulatory affairs and pharmacovigilance participate on behalf of the above entities. The agenda if the meeting is as follows: – The new pharmacovigilance legislation – Aspects related to the handling through national procedure of variations to MA terms, submitted in 2011– The various questions about pharmacovigilance legislation are to be submitted no later than 9 July, to the following e-mail addresses: daniela.pomponiu@anm.ro and nela.vilceanu@anm.ro. Questions related to variations through national procedure are to be submitted no later than 9 July, to the following e-mail addresses: tanta.ulieru@anm.ro and simona.badoi@anm.ro. The NNAMD looks forward to receiving nominal confirmation of participation until Monday, 16.07.2012, 14:00, at simona.badoi@anm.ro. The venue and time of the meeting depend on the number of participants. Information on such aspects will be published on the NAMMD website.