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FDA Guidance for Industry concerning Wholesale Distributor Verification Requirement for Saleable Returned Drug Products published

The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies".

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Brexit: MHRA updates Guidance

MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK.

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Track and Trace: What to do with Recalls?

When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?

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ECA GDP Association represented at 5th Annual International GDP Conference in Serbia

The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."

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Brexit: Acting as a Responsible Person (import) (RPi)

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Guidance called "Acting as a Responsible Person (import) from 1 January 2021". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi.

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Drug Shortages: a European Solution at Last?

The European Parliament wants the European Union to become more independent with regard to pharmaceuticals and medical devices. A report on this has now been developed and adopted.

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What happens when Product is delivered before Release?

A Warning Letter was sent to a company who shipped product without a release.

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Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

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EU: Checklist for Brexit Preparation

The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK.

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