Ireland could provide the answers to the UK pharmaceutical’s problems
The European Medicines Agency (EMA) and the European Commission have issued a new guidance which focuses heavily on the practical implications that Brexit will have on companies in the pharmaceutical industry. The EU enforces strict regulation for medicines throughout its member states. The UK’s impending exit from the EU is set to cause huge regulatory issues for industry.
Post Brexit, UK based pharmaceutical companies will not be able to sell their products across the EU due to the fact that they can no longer rely on marketing authorisations (MAs) issued by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Pharmaceutical companies need to take positive and practical steps to prepare for 30 March 2019 when the UK becomes a third country. Current EU law necessitates that MA holders of centrally authorised medicinal products must be established in the EEA. It also requires that batch release and pharmacovigilance processes take place in the EEA and are carried out by persons that are established in the EEA.
Once the UK has left the EU, active substances manufactured in the UK will be seen as imported active substances. Consequently, they will need to be manufactured in compliance with EU standards. Companies that manufacture finished products in the UK will be required to have a site for batch control within the EEA.
With this scenario quickly becoming a reality, pharmaceutical companies based in the UK will see the idea of relocating to Ireland as a good means of maintaining their links with the EU single market. 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:
1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Making a transfer using the new application procedure
Where the application does not meet the conditions laid down for this administrative transfer procedure or the applicant wishes to obtain an authorisation / licence / registration under conditions other than those specified, it may be transferred by applying for a new authorisation / licence / registration under the usual national procedure.
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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