- February 26, 2021
The trade deal, which was reached on 24 DEC 2020, avoids tariffs and quotas on goods traded between the EU and UK and sets forth some provisions for cooperation and alignment on a range of issues from transportation to environmental protection but avoids major topics such as foreign policy and defense.
The deal is currently operating on a provisional basis through 28 FEB 2021 until the European Parliament consents to the agreement and the European Council adopts the decision on the conclusion of the agreement. The agreement was signed by the Presidents of the European Council and Commission and approved by the UK Parliament on 30 DEC 2020.
For the pharmaceutical and biotech industries, the deal offers some provisions to smooth out trade between the Union and its former member, though companies will face additional barriers that did not exist prior to the split as the two parties will now function as separate legal and regulatory jurisdictions. However, the deal does not provide for any mutual recognition of standards for medical devices, meaning device makers will need to navigate different regulatory regimes for the EU and UK.
Companies will also need to decipher added regulatory complexities related to Northern Ireland, which will follow EU rules for medicinal products and medical devices according to the Northern Ireland Protocol.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released dozens of guidance documents explaining how clinical trials, drugs, medical devices and clinical trials will be regulated as of 1 January. The European Medicines Agency (EMA) has also put out guidance on Northern Ireland and considerations for the end of the transition period.
Medicinal Products
For medicinal products, the trade deal ensures some intellectual property protections and commits the two sides to adhere to international standards and allows for mutual recognition of inspections and good manufacturing practice (GMP) documents between the UK and EU member states, with some caveats.
The annex to the agreement on medicinal products states the two parties “shall recognize inspections carried out by the other Party and shall accept official GMP documents issued by the other Party,” but allows for regulators to reject official GMP documents under certain circumstances. “An authority of a Party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party for manufacturing facilities located in the territory of the issuing authority,” the agreement states. Parties may also accept GMP documents issued by authorities of the other party for facilities located outside the issuing authority’s territory but have leeway to set their own terms and conditions for accepting such GMP documents.
The EU and UK may request official GMP documents from each other’s regulators, and the two sides are committed to providing requested documents within 30 calendar days. The agreement also reserves the rights of each party to conduct their own inspections of facilities that have been certified compliant by the other party, though they must notify the other party before conducting an inspection and the regulatory authority of the other party may join in on the inspection.
The agreement also lays out guidelines for navigating changes to GMP requirements and suspending recognition of inspections and acceptance of GMP documents. Both parties are required to provide notice before changing GMP requirements pursuant to the laws, regulations and guidelines listed in the annex and are committed to engage within the Working Group on Medicinal Products when a change to GMP requirements would impact the other party’s ability to recognize inspections or accept GMP documents.
Lastly, the agreement calls on the parties to consult with one another on changes to technical regulations and inspection procedures and to cooperate on international scientific and technical guidelines.
REFERENCE: RAPS – Regulatory Focus (News Articles 2021 1); 05 JAN 2021; Michael Mezher