Regulatory Guidance for Pharmaceutical Companies to Prepare for UK’s Withdrawal from EU

With EMEA moving out its headquarters (HQ) from London to Amsterdam (according to Nov 2017 polls to select new HQ) after Brexit, The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU). The pharma companies are asked to plan in advance for upcoming changes that might affect their functioning with United Kingdom leaving EU on 29th March 2019. It is contemplated that this might impact on the supply of medicine within EU. The pharmaceutical industry is aware of the issues that might arise such as marketing authorization and supply of medicinal products across Europe.

In November 2017, the Agency published the first version of its procedural guidance for industry which outlines the practical and simplified requirements that companies should follow to make sure that necessary changes to their marketing authorization are made by the end of March 2019, to allow for the continued marketing of their medicine in the European Economic Area (EEA) after Brexit.

Companies are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU.

This list of Questions and Answers (Q&As) has been drafted jointly by the European Commission and EMA. This version is a first update of the initial list of Q&As published on 31 May. The Q&As may be further updated and complemented in the future.

 

  1. What if I am a marketing authorization holder established in the UK?

According to Article 2 of Regulation (EC) No 726/2004 the marketing authorization holder must be established in the Union. The marketing authorization holder will therefore need to transfer its marketing authorization to a holder established in EEA. This simply means that the marketing authorization organization needs to have official address of that in EU region to keep on the marketing practices ongoing, this change of address must be done before end of March 2019.

 

  1. What if I am an orphan designation holder established in the UK? (for medicines for human use)

By order, the sponsor of an orphan medicinal product designation must be established in the Union (EEA). For designated orphan medicinal products, the holder will therefore need to transfer its designation to a holder established in the Union (EEA).

 

  1. What if I am a UK company with a MUMS (Minor Use Minor Species/limited market) status for my product? (for veterinary medicines)

By order, if the sponsor/applicant is established in the UK, the MUMS incentives would no longer be applicable with effect from the date of the UK’s withdrawal from the Union, as a sponsor/applicant established within a third country cannot seek and receive MUMS/limited market classification in the Union (EEA).

 

  1. What if my Qualified Person for Pharmacovigilance (QPPV) resides and carries out his/her tasks in the UK?

According to Article 2 of regulation, the qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in a Member State of the Union (EEA). The QPPV will therefore need to change his/her place of residence and carry out his/her tasks in the Union (EEA) or a new QPPV residing and carrying out his/her tasks in EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY the Union (EEA) will need to be appointed. Changes in the QPPV, including contact details (telephone, and fax numbers, postal address and email address) may, for medicinal products for human use, be updated through the Article 57 database only (without the need for a variation) (see Variation Guideline C.I.8). Regarding medicinal products for veterinary use the changes should be updated through a variation (see Variation Guideline (2013/C 223/01), classification C.I.9).

 

  1. What if my Pharmacovigilance System Master File is located in the UK (PSMF)? (for medicines for human use)

According to Commission Implementing Regulation (EU) No 520/2012, the PSMF must be located within the Union (EEA). The marketing authorization holder will therefore need to change the location of the PSMF to a Member State within the Union (EEA).

 

  1. What if my manufacturing site of the active substance is in the UK?

As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances. Directive 2001/83/EC and Directive 2001/82/EC state that manufacturing authorization holders are obliged to use, as starting materials, only active substances that have been manufactured in accordance with the detailed guidelines on GMP for starting materials. In addition, pursuant to Article 46b(2) of Directive 2001/83/EC, active substances for medicinal products for human use shall only be imported in the Union (EEA) if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union (EEA).

 

  1. What if my manufacturing site of the finished product is in the UK?

As of the date of the withdrawal of the UK from the Union, medicinal products manufactured in the UK will be considered imported medicinal products. The competent authorities of the Union (EEA) shall ensure that the import of medicinal products into their territory is subject to an authorization in accordance with Article 40(3) of Directive 2001/83/EC and Article 44(3) Of Directive 2001/82/EC. The authorization is granted when a number of conditions, as defined in Articles 41 and 42 of Directive 2001/83/EC and Articles 45 and 46 of Directive 2001/82/EC, are fulfilled (e.g. availability of a qualified person within the Union (EEA), GMP inspection). For centrally authorized medicinal products the marketing authorization holder will therefore need to specify an authorized importer established in the Union (EEA) and submit the corresponding variation (see Variation Guideline (2013/ C 223/01), classification B.II.b.2).

 

These lists of questions were the commonly raised queries that have been addressed by the EMA authority and the list of questions shall be updated as and when necessary and it will be reflected in the EMA official website. In the latest version of the article, it was clearly advice to pharmaceutical companies and professionals to change their official address and location of function to EEA as any business and manufacturing activity in UK after Brexit will not be considered legal by the pharmaceutical companies and professional hence changing location to European Economic Area will be inevitable.