Romania - Important notice to the attention of Marketing
Authorisation Holders
- Name of the medicinal product;
- International Non-Proprietary Name (INN) of the active substance
contained in the respective medicinal product;
- Approved therapeutic indication(s);
- Approved presentation forms;
- Registration number in the Register of medicinal products for human use
authorised by the Community under the centralised procedure;
- Authorisation date;
- Procedure closure date;
- Type of procedure;
- Procedure number as given by the European Medicines Agency (EMEA);
- Number of the EC decision;
- Historic progress of post-authorisation changes, with approval
decisions: variations, renewals, transfers;
- Annexes to decisions:
- Annex I - SPC
- Annex II - Marketing Authorisation Holder and conditions
for authorisation
- Annex III – Leaflet and Labelling.
Links to the EMEA website also enable consultation of
European Public Assessment Reports (EPARs) centrally authorised medicinal
products.
The NMA also reminds interested parties that medicinal products authorised for
marketing or undergoing changes after Romania’s accession to the European Union
are provided with Romanian versions of approval decisions and specific annexes.
The NMA undertakes ongoing updating of the Excel table as posted on its website
with medicinal products newly authorised for marketing through the centralised
procedure.
EC approved changes are made available by means of the link to the Europe
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