The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. Following the ratification of the Withdrawal Agreement by the United Kingdom and the European Union in January 2020, the United Kingdom formally left the European Union on 31 January 2020 and became a third country to the EU. A transition period started on 1 February 2020, which ended on 31 December 2020.

Since May 2017, information notices and guidance documents on legal, regulatory and procedural requirements for companies have been published and regularly updated: in particular, the European Commission Notice to stakeholders (https://ec.europa.eu/info/files/medicinal-products-human-use-veterinary_en) and the CMDh Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (https://www.hma.eu/535.html).

If any of your medicinal products authorized in Italy has one or more of the following activities and/or entities still located only in the UK:

• Marketing authorisation holder,
• Pharmacovigilance system master file,
• Qualified Person for Pharmacovigilance,
• Batch control site(s) for finished product (except if they are located in Northern Ireland),
• Batch release site(s) for finished product (except if they are located in Northern Ireland),

taking into consideration that you have not made the necessary submissions or have not undertaken the relevant actions to ensure full compliance with the EU Pharmaceutical Acquis, you must no longer place new batches of such medicinal product(s) on the market until the situation is rectified.

You will therefore need to rectify as soon as possible the above listed non-compliant aspects of the marketing authorisation to ensure batches continue to be released in line with the legal requirements of Directive 2001/83/EC and submit the corresponding marketing authorisation transfer application/type IA_IN/IB/II variation(s)/update to the Article 57 database concerning the QPPV and/or PSMF no later than by 1 month from the date of this communication and/or submit the corresponding type IA variation(s) no later than by 2 months from the date of this communication, as applicable. If you will not be able to comply with these requirements, you are requested to give us a status update to the following e-mail address: exemption-brexit@aifa.gov.it, no later than 1 month from the date of this communication, indicating the product name(s) and national licence number(s), as well as MRP/DCP number (in case of MRP/DCP products).

If the necessary submission(s) will not be received within the above referred timelines, AIFA will consider taking appropriate regulatory action. The appropriate action could be to suspend or revoke the marketing authorisation(s) concerned on the basis of Article 116 and 118 of Directive 2001/83/EC or to prohibit the supply of the medicinal product on the basis of Article 117 of Directive 2001/83/EC and the corresponding national provisions.

With respect to batch release and QC testing, products with these activities still located in the UK but already released and placed on the market on the territory of the EU/EEA or UK before the end of the transition period, may be further made available on the market of the EU/EEA in line with Art 41 of the Withdrawal Agreement and do not have to be re-called from the market.

The present communication is without prejudice to any further changes that might be required for your medicinal product (e.g. removal from the dossier of importation, batch control and batch release sites located in Great Britain, when they are in addition to EU/EEA/UK(NI) sites, that is alternative batch release or batch control sites, or change of local representatives if currently still located in UK).

In particular, as for batch release and QC testing, alternative sites still located in the UK(GB) should be removed from the MA using the respective variation procedure according to the

The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. Following the ratification of the Withdrawal Agreement by the United Kingdom and the European Union in January 2020, the United Kingdom formally left the European Union on 31 January 2020 and became a third country to the EU. A transition period started on 1 February 2020, which ended on 31 December 2020.

Since May 2017, information notices and guidance documents on legal, regulatory and procedural requirements for companies have been published and regularly updated: in particular, the European Commission Notice to stakeholders (https://ec.europa.eu/info/files/medicinal-products-human-use-veterinary_en) and the CMDh Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (https://www.hma.eu/535.html).

If any of your medicinal products authorized in Italy has one or more of the following activities and/or entities still located only in the UK:

• Marketing authorisation holder,
• Pharmacovigilance system master file,
• Qualified Person for Pharmacovigilance,
• Batch control site(s) for finished product (except if they are located in Northern Ireland),
• Batch release site(s) for finished product (except if they are located in Northern Ireland),

taking into consideration that you have not made the necessary submissions or have not undertaken the relevant actions to ensure full compliance with the EU Pharmaceutical Acquis, you must no longer place new batches of such medicinal product(s) on the market until the situation is rectified.

You will therefore need to rectify as soon as possible the above listed non-compliant aspects of the marketing authorisation to ensure batches continue to be released in line with the legal requirements of Directive 2001/83/EC and submit the corresponding marketing authorisation transfer application/type IA_IN/IB/II variation(s)/update to the Article 57 database concerning the QPPV and/or PSMF no later than by 1 month from the date of this communication and/or submit the corresponding type IA variation(s) no later than by 2 months from the date of this communication, as applicable. If you will not be able to comply with these requirements, you are requested to give us a status update to the following e-mail address: exemption-brexit@aifa.gov.it, no later than 1 month from the date of this communication, indicating the product name(s) and national licence number(s), as well as MRP/DCP number (in case of MRP/DCP products).

If the necessary submission(s) will not be received within the above referred timelines, AIFA will consider taking appropriate regulatory action. The appropriate action could be to suspend or revoke the marketing authorisation(s) concerned on the basis of Article 116 and 118 of Directive 2001/83/EC or to prohibit the supply of the medicinal product on the basis of Article 117 of Directive 2001/83/EC and the corresponding national provisions.

With respect to batch release and QC testing, products with these activities still located in the UK but already released and placed on the market on the territory of the EU/EEA or UK before the end of the transition period, may be further made available on the market of the EU/EEA in line with Art 41 of the Withdrawal Agreement and do not have to be re-called from the market.

The present communication is without prejudice to any further changes that might be required for your medicinal product (e.g. removal from the dossier of importation, batch control and batch release sites located in Great Britain, when they are in addition to EU/EEA/UK(NI) sites, that is alternative batch release or batch control sites, or change of local representatives if currently still located in UK).

In particular, as for batch release and QC testing, alternative sites still located in the UK(GB) should be removed from the MA using the respective variation procedure according to the classification guideline. This should be done at the earliest opportunity for all procedures (no later than 12 months after implementation, according to Regulation (CE) n. 1234/2008, as amended by Regulation n. 712/2012, i.e. within the end of 2021) except for procedures where the competent authorities of IE, CY, MT and/or UK(NI) have granted an exemption for their markets.

UK(GB) sites may be permitted temporarily under the conditions for the exemption as stated in Commission Notice C/2021/450 (OJ C 27, 25.1.2021, p. 11–16) and if granted by the competent authorities of IE, CY, MT or UK(NI) for their markets (for a period of 12 months until the end of 2021).

guideline. This should be done at the earliest opportunity for all procedures (no later than 12 months after implementation, according to Regulation (CE) n. 1234/2008, as amended by Regulation n. 712/2012, i.e. within the end of 2021) except for procedures where the competent authorities of IE, CY, MT and/or UK(NI) have granted an exemption for their markets.

UK(GB) sites may be permitted temporarily under the conditions for the exemption as stated in Commission Notice C/2021/450 (OJ C 27, 25.1.2021, p. 11–16) and if granted by the competent authorities of IE, CY, MT or UK(NI) for their markets (for a period of 12 months until the end of 2021).

Published on: 15 January 2021