How US Pharma can prepare for Brexit
March 29th 2019 is not far away. This is the date that the UK is due to exit the EU, and it is going to take some planning and serious organization for a number of industries to be prepared for the uncertainty and disruption that awaits. As the UK will no longer be a part of the EU, it will not have free trade across the single market. This is an issue for a number of different industries. We have already heard Nissan and BMW voice their concerns. However, the pharmaceutical industry could be worst affected, as not only do they have supply chain issue to worry about, they also have the issue of regulation to tackle.
All US pharmaceutical companies based in the UK and trading in the EU must transfer their marketing authorization to a legal entity within the EU. Pharmaceutical companies can still manufacture products in the UK post Brexit, however, they will require batch release to be carried out in the EU.
What can US Pharmaceutical companies do?
For some US pharmaceutical companies who already have operations in the EU, choosing to move their marketing authorization to a new location seems like the best means of avoiding potential disruption to their business. In terms of relocating manufacturing, each case is unique, but the idea is feasible for some. When choosing to relocate, companies are advised to choose a destination that has a skilled workforce with experience in pharmaceuticals, a country with close industry-academia ties that produces the employees fit for purpose, and a country with a strong existing pharmaceutical industry.
Choosing a regulatory agency
The process of changing regulatory functions from one country to another is a complex one. A big problem facing US pharma companies are the regulations in US for any drugs manufactured in a company’s European facility. If we look at Ireland as an example, HPRA (Health Products Regulatory Authority - Ireland) has been recognized by FDA through an EU mutual-recognition agreement. As a result, Irish manufacturing sites would only require a HPRA inspection in order to allow their products to be sold in the US market. Any US pharma companies looking to change their regulatory agency are advised to select a country with FDA recognition.
The Health Products Regulatory Authority in Ireland (HPRA) has mentioned in its own guidance that it is ready to assist any pharmaceutical companies looking to relocate their operations to Ireland.
HPRA has published a guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines. It states that an MA transfer can be processed before a product is authorised or, for MAs, PPAs and DPRs, after it is authorised, to either a company related to the current holder or to an unrelated company.
Where the transfer happens before authorisation the new holder is required to notify the HPRA. For transfers after authorisation, the following conditions must be met:
- For transfer to a related company, the new authorisation / licence / registration holder must be an individual or company, which is either:
- a subsidiary of an existing holder or...
- formed due to the merger of previous holders.
- The existing authorisation / licence / registration must have a remaining period of validity of more than three months. If the period is less than three months, the existing authorisation / licence / registration must be renewed first before the transfer application can be processed.
- No change may be made, as part of the transfer application, to the authorisation / licence / registration schedule or approved SmPC. No change may be made to the technical data in Modules 3, 4 and 5.
- No change may be made to the texts of the labels and leaflet, other than the (P)PA/DPR number, the holder’s name and address and the company logo, as applicable. Any change to the layout and design must not adversely affect the readability of their contents.
- In relation to transfer of ownership of a product licence where there is no manufacturer specified in the licence being transferred, a declaration will be sought with the transfer application from the proposed marketing authorisation holder (MAH), confirming they are aware of the conditions of the licence in respect of the manufacturing site. The new company will be required to subsequently submit a variation application to add the manufacturing site in order to market the product after the transfer has taken place.
- For bulk transfer applications, only one application form is required. If necessary provide an annex listing of the (P)PA/DPR numbers, product names, and strengths.
For information on how to make an application for transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines click here.
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