Billev Pharma Aps is ready to assist in meeting these demands.

The new requirements in EU Regulation 726/2004 Article 57*) determining how marketing authorization holders should submit data electronically to EMA has finally after some delay been followed up by detailed guidelines**) which specifies how the regulation is to be implemented.

By 2 July 2012 ALL registered medicinal products (CP, MRP/DCP, national human as well as herbal medicinal products) in all EU countries must be included with a number of data in EMA’s new database. All data must be submitted via the EudraVigilance system already used for adverse event reporting. Only authorized users are able to enter data. Billev Pharma is an authorized user.

The actual reason for all this is that by 2015 the whole registration system must comply with the new ISO standards. This means that the database must be re-organised this year resulting in a workload just as big as in 2012.

Already now Billev Pharma is ready to help you in every possible way.
Because we are placed centrally in the negotiations about the progress of this giant project we will always have the most recent information.

We have further developed our registration database to be able to handle the collected data in the appropriate templates.

In addition to the construction of EMA’s large database all future variation application will have to be reported in the same system no later than 15 calendar days after approval.
We will be able to assist you with this also as our registration database is able to handle these reports.

For all companies this will only be possible through a close teamwork between the companies’ Medical Affairs departments and the Registration departments; something which will require a lot of resources.

EMA has made it quite clear that it is a matter of “take it or disappear”.

Billev Pharma can be the link that eases the pressure on your departments.

Let us discuss the project and show you how we can be of use.


  *) http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm
**) http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content...