The EU rules in the field of medicinal products, in particular Regulation (EC) No 726/2004,6 Directive 2001/83/EC,7 and Directive 2001/82/EC,8 no longer apply to the United Kingdom.
For Pharmaceutical manufacturers it is important to consider in all business and legal decisions the impact of doing business activities with a ‘third party’. Brexit has many consequences such as changes to the Marketing Authorization procedures, manufacturing and importation of finished products and active pharmaceutical ingredients, GMP authority inspections and additional controls for batch release, the role of the pharmacovigilance QP and post marketing safety features, labeling and leaflet changes, GMP certification and so on.
The stipulation of all the details of the changing rules into this particular blog will bring us too far from the purpose of this writing, being a short notice on the awareness of the regulatory changes.
We would like to inform you that the websites of the European Commission provide additional information on this topic.
AM Consultancy will remain on board while in this turbulent time of Brexit and Covid-19 challenges, the need for pharmaceutical companies to remain regulatory compliant is essential for their current and future activities. Our GMP activities will be performed at both sites of the channel.