Safety Features (Medicinal Products For Human Use)

Article 33(1) of Commission Delegated Regulation (EU) 2016/161 requires marketing authorisation holders to ensure that unique identifiers and related information are uploaded to the EU repository system before a product is released for sale or distribution. The information on products released on the market before the end of the transition period will be already present in the national repositories where the product is intended to be placed on the market and there is no need to transfer information from the UK repository.

The responsibility for ensuring that the information is uploaded in the repositories system lies with the marketing authorisation holder. The infrastructures, hardware and software used for data upload must be physically located in the EU.

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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