Inspection Results

Outcomes of inspections conducted by the UK competent authority before the end of the transition period - It is expected that findings of inspections, in particular to determine compliance with good manufacturing practice, good clinical practice and pharmacovigilance obligations, conducted by the UK competent authority before the end of the transition period are implemented by the inspected entities in accordance with the applicable legislation, in particular Directive 2003/94/EC, Commission Delegated Regulation (EU) No 1252/2014 and Directive 91/412/EEC with regard to good manufacturing practice, Directive 2001/20/EC and Commission Directive 2005/28/EC with regard to good clinical practice and Regulation (EC) No726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU).

EU GMP certificate issued by UK authorities before the end of the transition period -All medicinal products for human use and veterinary medicinal products manufactured or imported into the EU are to be manufactured in accordance with the principles and guidelines of good manufacturing practice. A certificate of good manufacturing practice ("GMP certificate") is issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice.

While EU legislation does not require an EU GMP certificate that is issued by an EU Member State for issuing a marketing authorisation, in practice GMP certificates issued by EU competent authorities are used to confirm EU GMP compliance in regulatory submissions and for imports from third countries.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

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