EU: Derogations for medicinal products from the United Kingdom

 

The EU Commission has published a Proposal for a Directive of the European Parliament and of the Council amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta.

To ensure legal certainty and predictability the notified draft measure provides for permanent derogations from EU pharmaceutical law to ensure the continued long-term supply of and access to medicines from Great Britain to Northern Ireland (“NI”). In addition, it provides for three-year derogations to address outstanding supply concerns for Cyprus (“CY”), Malta (“MT”) and Ireland (“IE”).

Upon fulfilment of certain conditions as applicable, amendments to Directives 2001/20 and 2001/83 would allow imports of medicines without EU manufacturing and import authorisation from parts of the United Kingdom other than Northern Ireland. In addition,  amendments to Directive 2001/83 would allow the following:

For NI + CY/MT/IE

• localisation of regulatory functions in parts of the United Kingdom other than Northern Ireland;
• exports of medicines to parts of the United Kingdom other than Northern Ireland and subsequently into NI/CY/MT/IE without the need to repeat batch testing if already carried out in the EU;
• quality control testing carried out in parts of the United Kingdom other than Northern Ireland;

for CY/MT

• the placing on the CY/MT market of a medicinal product based on an authorisation by a competent authority in parts of the United Kingdom other than Northern Ireland.

For NI

• the supply to patients in NI of innovative medicines at the same time as any other patients in other parts of the United Kingdom other than Northern Ireland;
• the marketing authorisation applicant to choose between the mutual recognition/decentralised procedures and the national authorisation procedure in respect of NI.

Background of the proposal:

Pursuant to the Protocol on Ireland / Northern Ireland of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, medicines placed on the market in Northern Ireland must be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisations) or the United Kingdom (UK) in respect of Northern Ireland.  These national authorisations shall be in compliance with the obligations of the EU acquis for medicinal products.

During these last years, the UK as well as the small markets of the European Union (i.e. Malta, Ireland and Cyprus) that are dependent on supply of medicinal products from the United Kingdom have raised issues with respect to the ability of economic operators to comply with all provisions of the acquis for medicines after the end of the transition period provided for in the Withdrawal Agreement (de facto mostly for generics and over-the-counter medicines).

There are two possible national authorisation routes: purely UK national authorisations (“Northern Ireland-only authorisations”), which concern medicines that are made available in Northern Ireland only, and UK national authorisations issued under Union law procedures involving at least another Member State.

The Commission Notice of 25 January 2021 provided for a grace period of one year (until end-December 2021) for maintaining batch testing and manufacturing / logistics in parts of the United Kingdom other than Northern Ireland to ensure undisrupted supply of medicines to Northern Ireland, Cyprus, Ireland and Malta).

Despite the transition period, it still proves very difficult for certain operators currently based in parts of the United Kingdom other than Northern Ireland to adapt and move relevant regulatory compliance functions (namely, the marketing authorisation holder, quality control (batch) testing, the qualified persons responsible for batch testing pharmacovigilance) to Northern Ireland or the EU in respect of nationally authorised products, as required by the Protocol. The main reasons are the too high adjustment costs relative to the small size of the Northern Irish market and the complex logistics involved, for which no viable alternative logistical hubs in Northern Ireland have been identified.

The objectives of this proposal are to address the issues related to the human medicinal products, to prevent shortages of medicines and ensure adequate level of public health protection in Northern Ireland, Cyprus, Ireland and Malta.

This proposal allows exceptionally that:

– A marketing authorisation holder may be established in parts of the United Kingdom other than Northern Ireland;

– The manufacturing authorisation holder may be located in parts of the United Kingdom other than Northern Ireland;

– The batch testing may be carried out in parts of the United Kingdom other than Northern Ireland;

– The qualified person for batch testing and pharmacovigilance may be located in parts of the United Kingdom other than Northern Ireland;

– An EU wholesaler located in Northern Ireland, Cyprus, Ireland, or Malta may purchase and obtain medicines from a third country (parts of the United Kingdom other than Northern Ireland) without holding a manufacturing import authorisation and without re-testing the products.

The full text of the draft proposal is available HERE