March 4, 2019
The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared. Although the UK is in negotiations with the EU to streamline the transitions, the European Medicines Agency (EMA) has requested the pharmaceutical marketing authorization holders (MAHs) to stay prepared in advance to ensure continued supply of medicines.
Impact on the Pharmaceutical Industry
The UK has been the base for market authorizations of many medicinal products which have been recognized in other EU countries via Mutually Recognized Procedure (MRP) to obtain market-entry approvals. Almost a third of approved products’ MAHs in the EU are based in the UK and they must obtain an exclusive authorization from the Union to continue the supply. The companies marketing in the UK and based in any of the EU member states must also obtain a separate Medicines and Healthcare Products Regulatory Agency (MHRA) approval. Similar conditions will apply for market authorizations approved through Centralized Procedure (CP).
Artwork Regulatory Challenges
While getting approvals in the EU and UK is the endpoint, in order to be compliant, MAHs must also look into the artwork and packaging requirements that may rise due to the change in the country of origin. The packaging containers affected by artwork changes includes but is not limited to:
- Cartons
- Foils
- Containers
- Tubes
- Inserts
- Packets
- Shippers
All the packaging containers listed above might have representatives details as per existing MAHs. But with the need to obtain new approvals, the registered addresses of the legal entities and other mandatory details might also be changed. Aligning with all the requirements and obtaining a market approval in the midst of stringent timelines will be a challenging task.
With Brexit transition deadlines inching closer, pharmaceutical manufacturers must ensure they are adequately prepared to continue marketing without any compliance issues.
To expedite the process of submission for marketing authorization approvals (MAAs), consulting a Regulatory expert for artwork and submission is advised. Be compliant.
