Last month the EMA published the new good pharmacovigilance practice (GVP) chapter IV. This chapter has specific considerations for the paediatric population addressing the needs and challenges [...]
The PRAC’s November meeting (27th – 30th) saw a host of topics discussed, including: The commencement of a review of Esmya (ulipristal acetate), a medicine used to treat uterine [...]
The EMA has released an action plan in order to improve the product information (PI) for EU medicines. PI is the information package for patients and HCPs that accompanies all medicines [...]
Held at the Fira de Barcelona, Panacea attended the annual CPhI worldwide (one of the world’s largest pharmaceutical trade shows) for a sixth consecutive year. The conference is a great [...]
The development of the Extended EudraVigilance Medicinal Product Dictionary and how this has impacted and continues to impact on Marketing Authorisation Holders.
December 2001 the European Medicines Agency (EMA) launched EudraVigilance In December 2001 the EMA launched EudraVigiliance (Regulation (EC) No. 726/2004). This regulation is also known as [...]
Since July 2015, it has been mandatory to submit applications using electronic application forms (eAFs) for marketing authorisations through the centralised procedure. From the beginning of 2016, [...]