Romania - Notice on Change of Access to Information on Centrally Authorised Medicinal Products

The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH).

 

The table also provides links to the website of the Pharmaceuticals Unit in the Directorate-General for Enterprise and Industry of the European Commission (EC), including the Community Register of medicinal products that have received a marketing authorisation through the centralised procedure. This insures a much greater body of information for all parties interested on centrally authorized medicinal products, permanently updated by the EC, such as:

- 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 European Commission website.


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