After Brexit: Guidelines of Regulation Relating to Health Products Update
On 13 March 2020, the European Commission and the European Medicines Agency (EMA) updated their Guidelines on the impact of the UK’s exit from the European Union on medicines for human and veterinary use. As the United Kingdom officially became a third country from 1 February 2020, the relations between the parties will undergo profound changes at the end of the transition period, which runs until 31 December 2020.
At the end of the transition period, Regulation 726/2004 will no longer be applicable in the United Kingdom. This has several consequences. First, the marketing authorization holder (MAH) must have transferred it to a holder established in the European Union by 31 December 2020. Furthermore, as regards the pending MA applications from applicants established in the United Kingdom, the latter will be replaced by an applicant established in the Union. Finally, at the end of the transition period the UK authorities will cease to play the role of authority of surveillance regarding medicines imported from third countries. Therefore, it will be the new European Union surveillance authority that will assume responsibility for the manufacturing sites located in the United Kingdom and in third countries to decide, according to a risk assessment, when an inspection of the site or sites will be necessary.
At the end of the transition period, Directives 2001/83 and 2001/82 will also no longer be applicable in the United Kingdom. With regard to marketing authorizations relating to a generic or hybrid medicine, those issued before the end of the transition period and which refer to the dossier of a reference medicine (Reference medical product, RefMP) authorized by the United Kingdom will remain valid in the European Union. For applications relating to a generic or hybrid medicinal product whose marketing authorization will be issued after the end of the transition period, the applicant will have to refer to a RefMP authorized in a Member State of the Union of 27 if the authorization is issued earlier the end of the transition period. If, however, the RefMP was authorized after the end of the transition period, the latter must be authorized again in one of the Member States of the Union.
Regarding the so-called “sunset clause”, if a centrally authorized medicinal product has been marketed only in the United Kingdom, the placing on the United Kingdom market will be considered to determine its applicability before the end of the transition period. In this regard, if after the end of this period the medicinal product has not yet been placed on the market in any of the other Member States, the three-year period for calculating the sunset clause will begin to run from the last date on which the medicinal product was placed on the UK market before the end of the transition period.
At the end of the transition period, medicines sent from the United Kingdom to destinations in the European Union will be considered imported medicines. With regard to centrally authorized medicinal products, the MAH will then have to specify an authorized importer established in the Union and communicate the corresponding variation, as well as change the location of the current batch release site located in the United Kingdom in favour of a site established in the European Union. Furthermore, at the end of the transition period, the active substances produced in the United Kingdom can only be imported into the European Union if, inter alia, they are accompanied by a written attestation from the competent authority of the exporting third country which, as far as regards the manufacturing plant of the exported active substance, the standards of good manufacturing practice and control are equivalent to those of the Union.
Parallel trade in medicinal products in the internal market is currently possible not only thanks to European standards which provide for the exhaustion of trademark rights, but also because the summary of product characteristics and labelling are identical, except than for the language used. However, at the end of the transition period, the exhaustion rules will no longer be applicable to products placed on the market in the United Kingdom, which, in practice, will put an end to parallel trade.
As regards pharmacovigilance, at the end of the transition period, the qualified manager who currently performs his duties in the United Kingdom will have to change the place of residence and perform his duties in the European Union or, alternatively, designate a new one. In addition, the MAH must change the location of the Pharmacovigilance System Master File (PSMF) reference file by transferring it to a Member State of the Union.
Also as regards orphan medicinal products, at the end of the transition period the holder of the designation located in the United Kingdom will have to change the place of residence or transfer the relevant qualification to a holder established in the European Union. Furthermore, for applications for orphan designation or for keeping them in force, patients in the United Kingdom will no longer be considered in calculating the prevalence of the disease in order to meet the requirements of Regulation 141/2000.
Finally, as for cosmetic products also in this case, medicines legally placed on the European Union or United Kingdom market before the end of the transition period will continue to circulate until reaching the end user. However, the operator will have the burden of proving, through any relevant document, that the product was actually placed on the market before the end of the transition period.
For more information, please contact Dr Marina Mauro:
T: +39 0287 398 550