Brexit: Agreement on Northern Ireland Protocol also with Consequences for Medicines

As reported several times in the press, the European Commission and the government of the United Kingdom (UK) have reached an agreement on special regulations for Northern Ireland ("Windsor Framework") after tough wrangling. A solution for a handling medicines is also part of the agreement:

Authorisations and importation into Northern Ireland

In the future, "novel medicines" authorised by the UK Medicines Agency MHRA will also be available in Northern Ireland under the same conditions. These novel medicinal products must then be authorised and placed on the market according to UK regulations. Corresponding EU regulations and authorisations no longer apply in this case. This in turn means that companies need to be authorised to supply medicines to Northern Ireland. If they are, the European Medicines Agency (EMA) requirements can be neglected.

Safety features

Medicines that are then on the market in Northern Ireland may not enter the EU internal market. Prescription medicines will then not be allowed to carry EU safety features! The requirements of the relevant EU Directive (Falsified Medicines Directive) and the associated Delegated Regulation (EU) 2016/161 relating to safety features for medicinal products will be repealed for Northern Ireland. The packaging design can then be aligned for the entire United Kingdom (i.e. including Northern Ireland). In order to include non-prescription medicines, all medicines marketed in Northern Ireland will bear the words "UK only".

Distribution from Great Britain to Northern Ireland

The planned adjustments will then eliminate customs formalities and controls for medicines brought from Great Britain to Northern Ireland. Here, the so-called new "green lane" must then be observed during transport. What is this?

This "green lane" (a UK internal market scheme) means that traders moving goods to Northern Ireland will be exempt from controls and customs duties by using only ordinary commercial information, as with the movement of goods within the UK. All goods destined for the EU will use the so-called "red lane".

So far, the Windsor Framework is just a draft that still needs to be translated into legally binding instruments.

Sources:
EU Commission press release
UK Gov Press release Windsor Framework unveiled to fix problems of the Northern Ireland Protocol