Regulatory News

Draft on Labeling Requirements for IMPs Published

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

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EMA tackles the Issue of Remote Batch Certification

EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).

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Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

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News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

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Who needs to review Batch Records?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a requirement.

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Swissmedic specifies Requirements for GMP Certificates

The Swissmedic specified its requirements for the validity of GMP certificates in the pandemic.

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Final Annex 21 published

The final version of Annex 21 to the EU GMP Guidelines ("Importation of medicinal products") was published in EudraLex Vol. 4. There were a few important additions and clarifications to the draft.

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PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.

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Will the EU Concept of the QP spread the World?

The PIC/S has adopted the EU GMP Annex 16 and asks Member State authorities to implement it.

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EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

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