EMA Publishes New Q&A Guide on Brexit

There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Currently there is no MRA (Mutual Recognition Agreement) or any other agreement in place to regulate the future relationship between UK and EU. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Under the so called Northern Ireland Protocol "Northern Ireland will continue to enforce the EU's customs rules and follow its rules on product standards (known as the single market on goods). And this will make checks on goods travelling from Northern Ireland (a non-EU country) into the Republic of Ireland (an EU country) unnecessary. The protocol is due to come into force on 1 January 2021 - the first day of the new EU-UK relationship. Until then, the UK remains in a transition period with the EU, meaning its trading relationship stays the same as before" (Source BBC Explainer).

The now published Q&A Guidance document covers all areas concerned for medicinal products and APIs, e.g. Marketing Authorisation Procedures, Clinical Trial Procedures and also GMP related questions. Additional clarification has been provided on the question whether batch release control, batch release and batch certification has to be conducted by a manufacturer located in Northern Ireland. The EMA says:

"Each batch imported into the EU/EEA has to undergo upon importation a full qualitative analysis, aquantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. Based on the provisions of Protocol on Ireland/Northern Ireland, the batch release by an importer/manufacturer established in Northern Ireland will be recognised in the EU/EEA also after 31 December 2020. Similarly, quality control testing for the purpose of release to the market conducted by testing sites established in Northern Ireland will be recognised in the EU/EEA. Conversely, medicinal products shipped from Great Britain to Northern Ireland after 31 December 2020 will be considered imports and will be subject to the above requirements concerning importation, quality control testing and batch release. Where packs of medicines are shipped from one part of the internal market (e.g. France) to another part of the internal market (i.e. Ireland) via the ‘land bridge’, i.e. by using the transit procedure of the Common Transit Convention, these products are not placed on the UK market and hence do not require to be imported, to undergo quality control testing and QP release upon arrival in Ireland. The same applies to medicines shipped from the EU/EEA to Northern Ireland."

The document covers the following further GMP questions:

  • Can Official Control Authority batch release (OCABR) and Official Batch Protocol Review (OBPR) be conducted in Northern Ireland for centrally authorised medicinal products?
  • How will the manufacturing and import authorisations, GMP certificates and GMP noncompliance statements for sites in Northern Ireland be issued and made available?
  • How will the wholesale distribution authorisations, GDP certificates and GDP NonCompliance statements for sites in Northern Ireland be issued and made available?
  • What requirements will apply to sourcing of active substances from Northern Ireland? (medicinal products for human use)

Source:  EMA Guidance to Stakeholders "Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland

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