We have assisted with the National procedure from the very beginning of our history in 1978.
Now this procedure has been mostly replaced by European procedures. The National procedure is however still a relevant option if a marketing authorisation is desired in only one European member state.
The National procedure is also the starting point for the Mutual Recognition procedure (MRP). It should be pointed out that due to lack of resources at the different European health agencies a national application followed by MRP can be a slightly longer exercise than the Decentral procedure (DCP).
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
Latest News
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Are you lacking the capacity or qualification to perform an audit?
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...