At a meeting of the EU-US Trade and Technology Council, the US and EU reached an agreement to mutually recognize the results of Good Manufacturing Practice (GMP) inspections of veterinary products. This means that veterinary products manufactured in the EU can now be exported and marketed in the US without a prior inspection of EU manufacturers by the US and vice versa. This decision follows a previous similar decision on medicines for human use.
The US Food and Drug Administration (FDA) has already recognized the ability of 16 EU Member States to conduct GMP pharmaceutical inspections of veterinary products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. The US assessment of the remaining Member State competent authorities is proceeding according to a timetable agreed with the US. The target date for the completion of the assessment of all EU authorities has been set at July 2024. Read more here
ELS can and does register all types of veterinary products in Europe and the USA and can also help you to obtain GMP certification.
Please contact your ELS local consultant or through the email: info@elssolutions.pt
