Legal provisions of COM(2023)122 - Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland

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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 EN
date June 14, 2023

Contents

Article 1 - Subject matter and scope

1. This Regulation lays down specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC.

2. This Regulation also lays down rules regarding the suspension of the application of the specific rules laid down in this Regulation.

3. The provisions listed in Annex 2 to the Protocol on Ireland/Northern Ireland (the Protocol) shall apply in respect of the placing on the market in Northern Ireland of the medicinal products referred to in paragraph 1 of this Article, unless specific provisions are laid down in this Regulation.

Article 2 - Definitions

For the purposes of this Regulation, the definitions laid down in Article 2 of Regulation No 726/2004 shall apply, including the definitions laid down in Article 1 of Directive 2001/83/EC.

Article 3 - Specific rules for medicinal products referred to in Article 1(1)

1. The competent authorities of the United Kingdom in respect of Northern Ireland may allow medicinal products referred to in Article 1(1) of this Regulation to be imported into Northern Ireland from other parts of the United Kingdom by holders of a wholesale distribution authorisation that are not in possession of a relevant manufacturing authorisation provided that the conditions laid down in Article 40(1a) points (a) to (d) of Directive 2001/83/EC are fulfilled.

2. The safety features referred to in Article 54, point (o), of Directive 2001/83/EC shall not appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products referred to in Article 1(1) of this Regulation.

3. Where a medicinal product referred to in Article 1(1) of this Regulation bears the safety feature referred to in Article 54, point (o), of Directive 2001/83/EC, it shall be fully removed or covered. 

4. The qualified person referred to in Article 48 of Directive 2001/83/EC shall, in the case of medicinal products referred to in Article 1(1) of this Regulation, ensure that the safety features referred to in Article 54, point (o), of Directive 2001/83/EC have not been affixed on the packaging of the medicinal product.

5. Holders of a wholesale distribution authorisation shall not be required to:

(a)verify the medicinal products referred to in Article 1(1) of this Regulation in accordance with Article 80, point (ca), of Directive 2001/83/EC;

(b)keep records in accordance with Article 80, point (e), of Directive 2001/83/EC.

6. For all supplies of medicinal products referred to in Article 1(1) of this Regulation to a person authorised or entitled to supply medicinal products to the public, as referred to in Article 82 of Directive 2001/83/EC, as regards the United Kingdom in respect of Northern Ireland, the authorised wholesaler shall not be required to enclose a document in accordance with the last indent of the first paragraph of that Article.

Article 4 - Specific rules for medicinal products referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004

1. A medicinal product referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 that has been granted a marketing authorisation in accordance with Article 10 of that Regulation, shall not be placed on the market in Northern Ireland. 

2. A medicinal product referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 may be placed on the market in Northern Ireland if all the following conditions are met:

(a)the competent authorities of the United Kingdom have authorised the placing on the market of the product in accordance with the law of the United Kingdom and under the terms of the authorisation granted by the competent authorities of the United Kingdom;

(b)the medicinal product concerned is labelled in accordance with Article 5; 

(c)written guarantees are provided by the United Kingdom to the European Commission in accordance with Article 8.

Article 5 - Specific rules for labelling requirements for medicinal products referred to in Article 1(1)

Medicinal products referred to in Article 1(1) shall bear an individual label which shall comply with the following conditions:

(a)it shall be attached to the packaging of the medicinal product in a conspicuous place in such a way as to be easily visible, clearly legible, and indelible; it shall not be in any way be hidden, obscured, detracted from, or interrupted by any other written or pictorial matter or any other intervening material.

(b)it shall state the following words: ‘UK only’

Article 6 - Monitoring of medicinal products referred to in Article 1(1)

The competent authority of the United Kingdom shall continuously monitor the placing into the market in Northern Ireland of medicinal products referred to in Article 1(1) and the effective enforcement of the specific rules laid down in Articles 3, 4 and 5.

Article 7 - Prohibition on the movement to or placing on the market in a Member State of medicinal products referred to in Article 1(1)

1. Medicinal products referred to in Article 1(1) shall not be moved from Northern Ireland to a Member State or be placed on the market in a Member State.

2. The Member States shall apply effective dissuasive and proportionate sanctions in the case of non-compliance with the rules laid down in this Regulation. 

Article 8 - Written guarantees by the United Kingdom to the European Commission

The United Kingdom shall provide the European Commission with written guarantees that the placing on the market of the medicinal products referred to in Article 1(1) does not increase the risk to public health in the internal market and that those medicinal products will not be moved to a Member State, including guarantees to the effect that:

(a)economic operators comply with the labelling requirements laid down in Article 5;

(b)effective monitoring, enforcement and controls of the specific rules laid down in Articles 3, 4 and 5 are in place and are carried out, by means of, inter alia, inspections and audits.

Article 9 - Suspension of the special rules laid down in Articles 3, 4 and 5

1. The Commission shall continuously monitor the application by the United Kingdom of the specific rules laid down in in Articles 3, 4 and 5.

2. Where there is evidence that the United Kingdom does not take appropriate measures to address serious or repeated infringements of the specific rules laid down in Articles 3, 4 and 5, the Commission shall inform the United Kingdom by means of written notification.

3. For a period of three months from the date of that written notification, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that written notification. In justified cases, the Commission may extend that period by three months.

4. If the situation giving rise to the written notification referred to in paragraph 2, first subparagraph, is not remedied within the time-limit referred to in paragraph 2, second subparagraph, the Commission shall be empowered to adopt a delegated act, in accordance with Articles 10 and 11 of this Regulation, specifying the provisions among those referred to in paragraph 1 whose application shall be temporary or permanently suspended.

5. Where a delegated act has been adopted in accordance with paragraph 3 of this Article, the provisions referred to in Articles 3, 4 or 5 as specified in the delegated act shall cease to apply on the first day of the month following the entry into force of the delegated act.

6. Where the situation giving rise to the adoption of the delegated act in accordance with paragraph 3 of this Article has been remedied, the Commission shall adopt a delegated act specifying those suspended provisions of Articles 3, 4 or 5 that shall apply again.

7. In that case, the provisions specified in the delegated act adopted pursuant to this paragraph shall apply again on the first day of the month following the entry into force of the delegated act referred to in this paragraph.

Article 10 - Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 9 shall be conferred on the Commission for a period of five years from the date of application referred to in Article 14 of this Regulation. The delegation of power shall be tacitly extended for periods of an identical duration unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of power referred to in Article 9 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 9 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 11 - Urgency procedure

1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 10(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.

Article 12 - Transitional provisions for safeguards requirements

Medicinal products that have been lawfully placed on the market in Northern Ireland before the date of application referred to in Article 14 of this Regulation, and that are not repackaged or relabelled after that date, may be further made available on the market in Northern Ireland until their expiry date without being required to comply with the specific rules laid down in Articles 3, 4 or 5.

Article 13 - Amendment to Directive 2001/83/EC

Article 5a of Directive 2001/83/EC is deleted from the date of application referred to in Article 14 of this Regulation.

Article 14 - Entry into force and application

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2025, provided that the United Kingdom has provided the written guarantees referred to in Article 8.

In the case that those written guarantees are provided earlier than 1 January 2025 or later than that date, this Regulation shall apply from the first day of the month following the month during which the United Kingdom provides these written guarantees.

The Commission shall publish a Notice in the Official Journal indicating the date from which this Regulation applies.

This Regulation shall be binding in its entirety and directly applicable in all Member States.