Brexit - European Commission Guidance on Application of Pharmaceutical Law to Cyprus, Ireland, Malta and Northern Ireland on 1 January 2021

• 23/12/2020
• Articles

Amidst rumours that a Brexit trade deal is closer than ever, the EU Official Journal publishes today, on 23 December 2020, a Commission notice on the “application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period” (see, attached copy; the Notice).

The Notice indicates that, in view of their historical dependence on medicine supplies from or through Great Britain, Cyprus, Ireland, Malta and Northern Ireland may need some additional time to adapt supply chains and take account of the end of the transition period, on 31 December 2020, during which EU law continued to apply to and in the UK.

According to the Notice, the key difficulties faced by these four markets in complying with the EU’s pharmaceutical acquis are as follows:

(i) a lack of operators holding a manufacturing authorisation required for importing medicinal products from third countries (including Great Britain);

(ii) difficulties to carry out quality control testing (“batch testing”) in the absence of a batch release site established in the EU; and

(iii) difficulties to comply with the requirements of the Falsified Medicines Directive relating to the placement of the unique identifier on medicinal products for human use.

To prevent medicine shortages and to ensure a high level of health protection, the Notice provides for regulatory flexibility in these areas.

First, the Notice authorises the health authorities of Cyprus, Ireland, Malta and the United Kingdom with respect to Northern Ireland to allow medicines to be imported from Great Britain by wholesalers which are not in possession of a manufacturing authorisation. Strict conditions apply. The authorisation will only be valid in 2021 and applies both to human and veterinary medicinal products and investigational medicinal products.

Second, and again subject to strict conditions, the Notice allows importers placing medicinal products supplied from or through Great Britain on the market in Cyprus, Ireland, Malta or Northern Ireland or wholesale distributors placing such medicinal products on those markets (see, previous point), to have certain controls carried out in Great Britain. This deviates from EU law in that quality control testing (“batch testing”) should normally take place in the European Economic Area.

Finally, the Notice exempts economic operators responsible for the export of medicinal products from the EU to Great Britain (placed on the market in the EU, exported to Great Britain and then imported into Cyprus, Ireland, Malta or Northern Ireland) from the obligation to decommission the unique identifier that may have already been affixed to the pack prior to the export. At the same time, it authorises, subject to conditions, the import into Ireland, Malta, Cyprus and Northern Ireland of medicinal products from Great Britain bearing non-decommissioned unique identifiers. The Notice explains that this derogation from EU law is necessary as there are currently no importers holding a manufacturing authorisation located in Cyprus, Ireland, Malta and Northern Ireland with capacity to meet the obligation to affix a new unique identifier as required by EU law as of 1 January 2021.