The European Commission has published a very useful factsheet entitled Protocol on Ireland/Northern Ireland, Supply of Medicines. It includes information on all of the following topics:
- Generic medicines and other medicines authorised at national level
- Regulatory functions (e.g. marketing authorisation holder, the manufacturing authorisation holder qualified person for batch testing and pharmacovigilance)
- Use of a single pack and leaflet across the UK
- Batch testing
- New medicines that are authorised centrally in the EU such as cancer medicines
- Manufacturing/import authorisations
- Unique identifier on packs of prescription medicines
Some of the information from the factsheet has been tabulated below and links provided to the appropriate documents, to facilitate understanding. Some text from the legislative proposals and the notice has also been added to the table to improve understanding.
Timeline
| Date | Summary | Legislative proposals |
|---|---|---|
| 17 Dec 2021 | The European Commission adopted two legislative proposals (see next column) for a series of targeted amendments to EU law. To ensure legal certainty and predictability, the proposals introduce permanent solutions for the continued long-term supply of medicines from Great Britain to Northern Ireland. In addition, they address outstanding supply concerns in Cyprus, Ireland and Malta. These proposals are accompanied by certain conditions to ensure the protection of the EU’s Single Market | 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. Objectives of the proposal 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 —————————————————————————————————————————————– Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta. Objectives of the proposal and what it allows The objectives of this proposal are to address the issues related to investigational medicinal products, to prevent an adverse impact on their supply and, as a result, on the execution of clinical trials authorised under Regulation (EU) 536/20143 in Northern Ireland, Cyprus, Ireland and Malta. This proposal allows exceptionally that the manufacturing and import authorisation is not required forinvestigational medicinal products imported into Cyprus, Ireland, Malta and Northern Ireland from parts of the United Kingdom other than Northern Ireland, provided that certain conditions are fulfilled. For Cyprus, Ireland and Malta, this derogation is of a temporary nature as it is expected that these markets will gradually be supplied through Member States. A transition period of 3 years seems sufficient. |
| 22 Dec 2021 | To guarantee the continued supply of medicines to Northern Ireland, on 22 December 2021 the Commission adopted an interpretative notice (see next column) to bridge the gap until the proposed legislative changes enter into force, which are intended to apply retroactively to 1 January 20222 | Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the United Kingdom other than Northern Ireland 2021/C 524/02 What is explained in the notice? The Commission considers it appropriate to explain in this Notice how it will apply, until 31 December 2022 or, as regards human medicines, until the date of entry into force of the amendments referred to in the notice, if that date is before 31 December 2022, the Union’s pharmaceutical acquis in those markets historically dependent on medicines supply fromor through parts of the United Kingdom other than Northern Ireland (i.e. Cyprus, Ireland, Malta and Northern Ireland). In that regard, the following areas, which have been identified by the Commission as the principal difficulties currently still faced by Cyprus, Ireland, Malta and Northern Ireland in complying with the Union’s pharmaceutical acquis, will be covered: 1) Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries; 2) Difficulties to carry out quality control testing (‘batch testing’); 3) Difficulties to comply with the provisions of Directive 2001/83/EC and Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier; 4) Specifically with regard to medicinal products for human use for the Northern Irish market, difficulties for some operators holding a marketing authorisation for medicinal products as well as for qualified persons for the manufacturing and pharmacovigilance of these products which are currently established in parts of the United Kingdom other than Northern Ireland to transfer their sites to the EU/EEA or to Northern Ireland; and 5) Specifically with regard to medicinal products for human use for the Cypriot and Maltese markets, difficulties to ensure access for patients to certain medicinal products due to the reliance of supply chains on parts of the United Kingdom other than Northern Ireland. |
| 13 Jan 2022 | -Directive 2011/62/EU (the Falsified Medicines Directive) sets out the Union’s legal framework for preventing falsified medicines from entering the legal supply chain and reaching patients. -Under Article 54a(2) of Directive 2001/83/EC (as amended by Directive 2011/62/EU), Delegated Regulation (EU) 2016/161 supplements the rules in Directive 2001/83/EC by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use. -These safety features include the affixing of a UI which allows medicinal products to be verified throughout the supply chain, and the addition of a tamper-evident device on each pack of medicines that can be prescribed. When a product is being exported to any third country, Article 22 of Delegated Regulation (EU) 2016/161 (see next column)provides that wholesalers must verify and decommission any UI previously affixed to a pack before it is exported. -EU Commission Delegated Regulation of 13 January 2021 amends Article 22 of Delegated Regulation (EU) 2016/161, waiving the requirement for wholesalers to decommission the unique identifier (UI) on packs of medicinal products entering the UK from the EU market, for a period of 12 months from 1 January 2021 to 31 December 2022. – This Delegated Regulation sets out one element of what was previously agreed by the UK and EU at the Withdrawal Agreement Joint Committee (WAJC) for the smooth implementation of the Northern Ireland Protocol. -Given that the UK is now a third country, the Falsified Medicines Directive (FMD) no longer applies. However, under the terms of the Northern Ireland Protocol (NIP), the Directive continues to apply in the UK in respect of Northern Ireland (NI). This means that medicines with a marketing authorisation valid in Northern Ireland will require a unique identifier and a tamper evident device on each pack. | COMMISSION DELEGATED REGULATION (EU) …/… of 13.1.2021 amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom |
Source: Europa website