Pharma

Why does Brexit matter for you?

The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that, unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) ('the withdrawal date'). The United Kingdom will then become a 'third country'.

If no withdrawal agreement is in place on 30 March 2019 the EU Treaties will cease to apply to the UK. It is understood that, should there be "no deal", there will be no transition period and EU law (in particular, the Single Market) will cease to apply to the UK/EU relationship from that date.

Preparing for the withdrawal is not just a matter for EU and national authorities, but also for private parties. As the British government publishes a series of technical notices outlining how businesses should prepare in the event of a no-deal it is becoming more and more clear that a “no deal” scenario will have many unwanted and adverse effects on companies in the UK.

In case of a hard Brexit, what will change?

Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. This has, in particular, the following consequences in the different areas of EU law on medicinal products:

• EU law requires that marketing authorisation holders are established in the EU (or EEA);

According to Article 2 of Regulation (EC) No 726/2004 the marketing authorisation holder must be established in the Union. Through the EEA Agreement this is extended to include also Norway, Iceland and Liechtenstein. For centrally authorised medicinal products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the Union (EEA) This means that the addressee of the marketing authorisation decision changes to the new addressee. The transfer of the marketing authorisation must be fully completed and implemented by the marketing authorisation holder before 30 March 2019.

• Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.

According to Article 8 of Directive 2001/83/EC and Article 74 of Directive 2001/82/EC, the qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in a Member State of the Union (EEA). The QPPV will therefore need to change his/her place of residence and carry out his/her tasks in the Union (EEA) or a new QPPV residing and carrying out his/her tasks in the Union (EEA) will need to be appointed.

How can we help you?

Our specialists are ready to guide your company through the swamp of regulatory issues in a post-Brexit landscape.

We provide advice on incorporating a company in Belgium in case you need to relocate or in case you need a EU – based company to continue your business.

Belgian government is working on creating an entrepreneur-friendly environment: corporate tax rate has been decreased to 29% and will further be lowered to 25% in 2020. SMEs will benefit a decrease in the rate to 20% (on the first tranche of 100.000 Euro), corporate law will be reformed by 2019 and provides more flexible corporate entities and less strenuous formalities.

Belgium is ideally positioned at the heart of Europe to continue your activities on the mainland.

back