(1)

The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (3) (the ‘Withdrawal Agreement’) was concluded on behalf of the Union by Council Decision (EU) 2020/135 (4) and entered into force on 1 February 2020. The transition period referred to in Article 126 of the Withdrawal Agreement, during which Union law continued to apply to and in the United Kingdom in accordance with Article 127 of the Withdrawal Agreement, ended on 31 December 2020. On 25 January 2021, the Commission issued a Notice (5) on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicinal products supply from or through Great Britain, namely Cyprus, Ireland, Malta and Northern Ireland, from the end of that transition period until 31 December 2021.

(2)

In accordance with the Protocol on Ireland/Northern Ireland (the ‘Protocol’), which forms an integral part of the Withdrawal Agreement, 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 Article 13 of Directive 2001/20/EC of the European Parliament and of the Council (6) regarding the manufacture and import of investigational medicinal products, Directive 2001/83/EC of the European Parliament and of the Council (7) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (8). Therefore, medicinal products placed on the market in Northern Ireland are to comply with those provisions of Union law.

(3)

Directives 2001/20/EC and 2001/83/EC lay down the rules for medicinal products for human use and investigational medicinal products intended to be placed on the market in the Member States.

(4)

Cyprus, Ireland, Malta and Northern Ireland have historically relied on the supply of medicinal products from or through parts of the United Kingdom other than Northern Ireland, and the supply chains for those markets have not yet been fully adapted to comply with Union law. To prevent shortages of medicinal products and ultimately to ensure a high level of public health protection, Directives 2001/20/EC and 2001/83/EC need to be amended to provide for derogations for medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from or through parts of the United Kingdom other than Northern Ireland. In order to ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

(5)

In accordance with Article 13(1) of Directive 2001/20/EC, read in conjunction with the Protocol, the import of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the holding of a manufacturing and import authorisation. To ensure continued access to new, innovative or improved treatments for clinical trial participants in Northern Ireland, as well as in Cyprus, Ireland and Malta after 31 December 2021, such a manufacturing and import authorisation should not be required for investigational medicinal products imported into those markets from parts of the United Kingdom other than Northern Ireland provided that certain conditions are fulfilled. To ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

(6)

Regulation (EC) No 726/2004 lays down Union procedures for the authorisation of medicinal products. Upon authorisation in the Union, medicinal products are available to patients in Northern Ireland. It is possible, however, that the competent authorities of the United Kingdom in respect of parts of the United Kingdom other than Northern Ireland issue a marketing authorisation for a medicinal product before a marketing authorisation has been granted for the same medicinal product in the Union. In such exceptional cases, and in order to ensure that patients in Northern Ireland have access to those medicinal products at the same time as patients in other parts of the United Kingdom, the competent authorities of the United Kingdom in respect of Northern Ireland should be able to supply those medicinal products to patients in Northern Ireland temporarily and until a marketing authorisation is granted or refused in the Union. In order to ensure the full effectiveness of the centralised procedure for granting marketing authorisations set out in Regulation (EC) No 726/2004, those temporary authorisations should be limited in time and should cease to be valid when the Commission takes a decision to grant or refuse the authorisation to market that medicinal product.

(7)

In accordance with Article 8(2) of Directive 2001/83/EC, read in conjunction with the Protocol, a marketing authorisation is only able to be granted to an applicant established in the Union or in Northern Ireland. A number of operators were not able to comply with that requirement by 31 December 2021. To ensure access to certain medicinal products in Northern Ireland, it is crucial that the holders of marketing authorisations granted by the competent authorities of the United Kingdom in respect of Northern Ireland are allowed to be established in parts of the United Kingdom other than Northern Ireland. Similarly, to ensure access to certain medicinal products in Cyprus, Ireland, Malta and Northern Ireland, it is necessary to allow the competent authorities of Cyprus, Ireland, Malta and Northern Ireland to grant marketing authorisations in the context of the mutual recognition or the decentralised procedure to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

(8)

It follows from Articles 17 and 18 of Directive 2001/83/EC, read in conjunction with the Protocol, that applicants for a marketing authorisation wishing to obtain both a marketing authorisation for the United Kingdom in respect of Northern Ireland as well as a marketing authorisation for one or more Member States need to include the United Kingdom in respect of Northern Ireland in the scope of their marketing authorisation application in accordance with the mutual recognition or the decentralised procedure. Where medicinal products are also authorised in parts of the United Kingdom other than Northern Ireland, the requirement to comply with that obligation could hamper the continuous access to medicinal products for patients in Northern Ireland. To avoid that issue, it is necessary to allow applicants in such situations the possibility to apply for a marketing authorisation for the United Kingdom in respect of Northern Ireland either in accordance with the mutual recognition or the decentralised procedure, or in accordance with the national marketing authorisation procedure applicable in relation to the United Kingdom in respect of Northern Ireland. In the case of such a national marketing authorisation procedure, the marketing authorisation should be granted in compliance with Union law, including the requirements on quality, safety and efficacy of medicinal products.

(9)

In accordance with Article 51(1), point (b), of Directive 2001/83/EC, medicinal products imported into the Union are to undergo quality control testing in the Union. Article 20, point (b), of that Directive allows the importers which place medicinal products supplied from or through parts of the United Kingdom other than Northern Ireland on the market in Cyprus, Ireland, Malta or Northern Ireland, or wholesale distributors placing such medicinal products on those markets, to have, in justifiable cases, certain controls carried out in parts of the United Kingdom other than Northern Ireland. Taking into account the historical dependence of Cyprus, Ireland, Malta and Northern Ireland on the supply of medicinal products from or through parts of the United Kingdom other than Northern Ireland and the related risks of shortages of medicinal products in those jurisdictions, a justifiable case within the meaning of Article 20, point (b), of Directive 2001/83/EC should be considered to occur when each batch of the medicinal product concerned is released by a qualified person on a site in the Union or by a qualified person on a site in parts of the United Kingdom other than Northern Ireland applying quality standards equivalent to those laid down in Union law, thereby ensuring an equivalent level of protection of human health. Since Article 20, point (b), of Directive 2001/83/EC only provides for batch testing to be carried out in a third country on a case-by-case basis, it is necessary to lay down conditions harmonising the implementation of that provision with regard to medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from or through parts of the United Kingdom other than Northern Ireland.

(10)

It follows from Article 40(3) of Directive 2001/83/EC, read in conjunction with the Protocol, that importers of medicinal products from third countries into a Member State are to hold a manufacturing authorisation granted by the Member State where the importer is established or, in the case of importers established in Northern Ireland, by the United Kingdom in respect of Northern Ireland. To avoid a situation in which operators withdraw from or significantly reduce medicinal products supply to Cyprus, Ireland, Malta and Northern Ireland, it is necessary to derogate exceptionally from that requirement under certain conditions and to allow imports of medicinal products from or through parts of the United Kingdom other than Northern Ireland into Cyprus, Ireland, Malta and Northern Ireland by wholesale distributors that do not hold the relevant manufacturing authorisation, while ensuring an equivalent level of protection of human health.

(11)

In a situation where medicinal products are exported from a Member State to parts of the United Kingdom other than Northern Ireland, and subsequently imported into Cyprus, Ireland, Malta or Northern Ireland, it should be possible to waive specific controls, namely quality control testing, intended to guarantee the quality of those medicinal products imported from third countries, provided that appropriate arrangements have been made by the Union to ensure that the necessary controls are carried out in the exporting country.

(12)

It follows from Article 48 of Directive 2001/83/EC, read in conjunction with Article 49 of that Directive and with the Protocol, that the manufacturing authorisation holder is to have at its disposal a qualified person who resides and operates in the Union or Northern Ireland. To ensure a continuous access to certain medicinal products to patients in Northern Ireland, it is appropriate to allow the qualified person to reside and operate in parts of the United Kingdom other than Northern Ireland.

(13)

It follows from Article 104(3) of Directive 2001/83/EC, read in conjunction with the Protocol, that the qualified person responsible for pharmacovigilance is to reside and operate in the Union or Northern Ireland. A number of operators were not able to comply with that requirement by 31 December 2021. To ensure that access to certain medicinal products for patients in Northern Ireland is not hampered, it is appropriate to allow the qualified person responsible for pharmacovigilance to reside and operate in parts of the United Kingdom other than Northern Ireland.

(14)

To avoid shortages of medicinal products in Cyprus and Malta, the competent authorities of Cyprus and Malta should be allowed, for public health reasons and for a certain period, to grant, maintain in force and extend marketing authorisations on the basis of Article 126a of Directive 2001/83/EC which rely on marketing authorisations granted by the competent authorities of parts of the United Kingdom other than Northern Ireland, even if the marketing authorisation holder is no longer established in the Union, provided that certain conditions are fulfilled. Since Union law no longer applies in parts of the United Kingdom other than Northern Ireland, it is necessary to provide that the competent authorities of Cyprus and Malta ensure that such authorisations comply with Union law. In order to ensure that the functioning of the Union market is not undermined, it is necessary to establish the conditions for enhanced supervision and enforcement of the rules relevant for the application of the derogations introduced by this Directive. The Commission should monitor developments in parts of the United Kingdom other than Northern Ireland that could affect the level of protection regarding the regulatory functions covered by this Directive. If the Commission finds that the level of protection of public health ensured by the United Kingdom by means of rules governing the production, distribution and use of medicinal products, as well as by means of the effective enforcement of those rules, is no longer essentially equivalent to that guaranteed within the Union, or if the Commission lacks information to assess whether an essentially equivalent level of protection is guaranteed, the Commission should enter into consultation with the United Kingdom to find a mutually agreed remedy to that situation. If no such remedy is found within the prescribed period, the Commission should, as a last resort, be empowered to adopt delegated acts suspending the application of one or more provisions introduced by this Directive.

(15)

In order to ensure transparency, the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland should publish a list of medicinal products to which they intend to apply or have applied the derogations set out in this Directive. In order to make that list easily searchable, it should contain the same information as that included in the package leaflet or summary of product characteristics of the medicinal products concerned.

(16)

Since the objectives of this Directive cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(17)

Directives 2001/20/EC and 2001/83/EC should therefore be amended accordingly.

(18)

In order to ensure legal continuity for operators active in the pharmaceutical sector and to guarantee the continuous access of patients in Cyprus, Ireland, Malta and Northern Ireland to medicinal products, this Directive should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union and the measures adopted by the Member States to comply with it should apply retroactively from 1 January 2022,

(a)

the investigational medicinal products imported into Cyprus, Ireland, Malta or Northern Ireland have undergone certification of batch release either in the Union, as provided for in paragraph 3, point (a), or in parts of the United Kingdom other than Northern Ireland in compliance with the requirements set out in paragraph 3, point (b);

(b)

the investigational medicinal products are only made available to subjects in the Member State into which those investigational medicinal products are imported, or, if imported into Northern Ireland, are only made available to subjects in Northern Ireland.’.

(1)

the following Article is inserted:

(2)

in Article 8, the following paragraphs are inserted:

(3)

the following Article is inserted:

(4)

in Article 20, the following paragraph is added:

‘With regard to quality control testing carried out in parts of the United Kingdom other than Northern Ireland regarding medicinal products included in the list referred to in Article 127d other than those authorised by the Commission, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta may consider that there is a justifiable case within the meaning of point (b) of the first paragraph, without carrying out a case-by-case assessment provided that:

(5)

Article 40 is amended as follows:

(6)

in Article 48, the following paragraph is added:

(7)

in Article 104(3), the following subparagraph is added:

‘By way of derogation from the second subparagraph, where the marketing authorisation is granted by the competent authority of United Kingdom in respect of Northern Ireland, the qualified person referred to in point (a) of the first subparagraph may reside and operate in parts of the United Kingdom other than Northern Ireland. This subparagraph shall not apply where the marketing authorisation holder already has at its disposal a qualified person who resides and operates in the Union on 20 April 2022.’;

(8)

the following Article is inserted:

(9)

Article 121a is amended as follows:

(10)

the following Article is inserted:

(11)

the following Articles are inserted: