Marketing Authorisation Holder

EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes a New Question and Answer Document for Marketing Authorisation Holders on the CHMP Opinion for the Article 5(3) referral on Nitrosamine Impurities in Human Medicinal Products (EMA/409815/2020) The European Medicines Agency (EMA) have published a new ‘question and…
Marketing Authorisation Holder GMP-related Responsibilities

Marketing Authorisation Holder GMP-related Responsibilities

Our Regulatory Affairs team have produced this article with the aim of summarising the key elements of the EMA Reflection Paper and the GMP-related responsibilities that apply to Marketing Authorisation Holders. The article also aims to assist our clients in…
Nitrosamine MAH Risk Assessment – Two Months to Go

Nitrosamine MAH Risk Assessment – Two Months to Go

Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities On 26 September 2019 the European Medicines Agency requested that, as a matter of precaution, all Marketing Authorisation Holders (MAH) should perform a risk evaluation for all…