New EU Commission Brexit Notice on Medicinal Products

Recommendation

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The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021 entitled "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 2021/C 27/08)".

Although the Brexit was a long time coming, there are supply problems with some medicinal procucts. The Covid-19 pandemic has therefore also prompted the EU to act. Cyprus, Ireland, Malta and Northern Ireland in particular have not yet fully adapted their supply chains. Three main problem areas have been identified:

1. absence of companies holding a manufacturing authorisation required for the import of medicinal products from third countries; 

2. difficulties in carrying out batch tests

3. difficulties in complying with the provisions of Directive 2001/83/EC and Delegated Regulation (EU) 2016/161 in relation to the application and verification of the unique identifier. 

Subject to the conditions set out in the EU notice, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom in relation to Northern Ireland would allow the importation of medicinal products from the United Kingdom by wholesalers who do not hold a manufacturing authorisation in accordance with Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82/EC. Nor would they suspend, revoke or withdraw marketing authorisations for these medicinal products under Article 118 of Directive 2001/83/EC and Article 84 of Directive 2001/82/EC. The EU Commission has also formulated an exemption for investigational medicinal products (IMPs).

With regard to batch testing, the EU Notice now also provides for an exemption for the countries concerned. In special cases and under the following conditions, certain tests can be carried out in the UK:

• Each batch of the medicinal product concerned is to be released by a Qualified Person in a place in the EU or by a Qualified Person in a place in the United Kingdom, applying quality standards equivalent to those laid down in Union law, thereby ensuring an equivalent level of protection of public and animal health in cases covered by Section 1.
• The entity designated by the third party to carry out the quality review is to be supervised by a competent authority, including on-site inspections. Verifiable progress towards transferring the quality testing location to the Union or Northern Ireland shall be demonstrated. In particular, the batch testing site should be established within 12 months of the end of the transitional period, i.e. by 31 December 2021 at the latest.

The third point in the EU notice concerns an exemption with regard to the so-called unique identifiers (keyword "serialisation / track & trace"). Due to the special situation, the competent authorities of these countries would - under certain conditions - allow the import of medicinal products from the UK which are provided with non-deactivated individual recognition features. The importer would normally be obliged to do this.

Please also see the exact wording of the 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 2021/C 27/08.