Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period

This guidance notice is intended to facilitate the application of the EU’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period by indicating how the Commission will apply to this specific situation the relevant provisions of Directives 2001/82/EC, 2001/83/EC, 2001/20/EC of the European Parliament and of the Council and the Commission Delegated Regulation (EU) 2016/161.

The Commission has identified the following challenges (described below) as the principal difficulties for the abovementioned markets which are historically dependent on medicines supply from or through Great Britain in complying with the Union’s pharmaceutical acquis:

1. Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries;

2. Difficulties to carry out quality control testing (‘batch testing’);

3. Difficulties to comply with the provisions of Directive 2001/83/EC and Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier.

Recognising these challenges, and taking into consideration the exceptional circumstances of the COVID-19 pandemic, the Commission takes note of the request, from both private and public stakeholders in the Union and the United Kingdom, for more time in the transition towards full compliance with the Union’s pharmaceutical acquis.