In May 2017 the European Commission and EMA jointly issued a document, Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use. In this document the Commission reminds companies that from midnight on 30 March 2019 the UK is no longer part of the EU and becomes a third country. The notice Continues as follows:
“In this regard, marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of certain legal repercussions, which need to be considered:
- EU law requires that marketing authorisation holders are established in the EU (or EEA)
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
Marketing authorisation holders may be required to adapt processes and to consider Changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.
Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.
PharmaConsult can provide Practical help and advice in establishing a legal entity in EU for you;
- Marketing Authorisation Holder; According to Article 2 of Regulation (EC) No 726/2004 the marketing authorisation holder must be established in the Union.
- Orphan Designation Holder: According to Article 2 of Regulation (EC) No 141/2000 the sponsor of an orphan medicinal product designation must be established in the Union (EEA).
- If you’re UK Company has MUMS (Minor Use Minor Species/limited market) status for my product? (for veterinary medicines) , the MUMS incentives would no longer be applicable with effect from the date of the UK’s withdrawal from the Union, as a sponsor/applicant established within a third country cannot seek and receive MUMS/limited market classification in the Union (EEA).
In all these cases Pharma Consult will assist in generating a legal entity which can act as a MAH for all your EU products and meet the statutory need for Safety and Quality.