Considerations on COM(2023)122 - Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland - Main contents
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| dossier | COM(2023)122 - Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland. |
|---|---|
| document | COM(2023)122  |
| date | June 14, 2023 |
(2) The Protocol on Ireland/Northern Ireland (the Protocol) forms an integral part of the Withdrawal Agreement.
(3) The provisions of Union law listed in Annex 2 to the Protocol apply, under the conditions set out in that Annex, to and in the United Kingdom in respect of Northern Ireland. That list includes, but it is not limited to, Directive 2001/83/EC of the European Parliament and of the Council 10 and Regulation (EC) No 726/2004 of the European Parliament and of the Council 11 . Therefore, medicinal products placed on the market in Northern Ireland are required to comply with those provisions of Union law.
(4) Directive 2001/83/EC lays down the rules for medicinal products for human use and Regulation (EC) No 726/2004 lays down Union procedures for the authorisation of medicinal products for human use.
(5) In order to take account of the specific situation of Northern Ireland, it is appropriate to adopt specific rules relating to the placing on the market of Northern Ireland of medicinal products for human use.
(6) It is appropriate to clarify that the provisions listed in Annex 2 to the Protocol apply in respect of medicinal products for human use intended to be placed on the market in Northern Ireland unless specific provisions are laid down by this Regulation. Where the specific provisions of this Regulation apply, and in the event of any inconsistencies between those specific provisions and the provisions listed in Annex 2 to the Protocol, those specific provisions should take precedence.
(7) Furthermore, it is important to lay down rules which ensure that the application of the specific rules laid down in this Regulation does not lead to an increased risk to public health in the internal market.
(8) The specific rules should include the prohibition to display the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland and the prohibition to place on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in Northern Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/161 12 should not apply to medicinal products for human use intended to be placed on the market in Northern Ireland.
(9) In respect of new and innovative products, the competent authorities of the United Kingdom should authorise the placing of these products on the market in Northern Ireland once certain conditions are fulfilled, including that the authorisation is granted in accordance with the law of the United Kingdom and that the products are placed on the market in Northern Ireland under the terms of the authorisation granted by the competent authorities of the United Kingdom, that these products comply with certain labelling requirements, and lastly that the written guarantees have been provided by the United Kingdom to the European Commission.
(10) At the same time, appropriate safeguards for the Union should be put in place in order to ensure that the application of the specific rules does not increase risks to public health in the internal market. Such safeguards should include continuous monitoring from the competent authority of the United Kingdom on the placing on the market in Northern Ireland of medicinal products for human use subject to specific rules laid down in this Regulation and a total prohibition on the movement to or placing on the market in a Member State of medicinal products subject to the specific rules laid down in this Regulation.
(11) Furthermore, it is appropriate to empower the Commission to adopt delegated acts to suspend the application of some or all of the specific rules laid down in this Regulation where there is evidence that the United Kingdom does not take appropriate measures to tackle serious or repeated infringements of these specific rules. In such an event, it is appropriate to provide for a formal information and consultation mechanism with clear time periods within which the Commission should act.
(12) In the case of the suspension of the specific rules for the placing on the market in Northern Ireland of the medicinal products, the relevant provisions listed in Annex 2 to the Protocol should apply again to such medicinal products.
(13) In order to ensure an effective and swift reaction to any increased risk for public health, this Regulation should provide for the possibility for the Commission to adopt delegated acts in accordance with an urgency procedure.
(14) It is appropriate to provide for a transitional period for the application of specific rules laid down in this Regulation to medicinal products for human use which are already on the market in Northern Ireland.
(15) As a consequence of the entry into force of this Regulation, Directive 2001/83/EC should be amended accordingly.