News

CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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EMA: More GMP/GDP Inspections performed

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

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What makes a good RP?

In its blog the Medicines and Healthcare products Regulatory Agency (MHRA) explains what the UK authority expects from a Responsible Person: knowledge, experience, training.

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PIC/S implements EU-GDP for APIs

PIC/S adopt EU GDP principles of GDP for active substances for PIC/S purposes.

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No Monitoring needed if there are no Storage Conditions on the Outer Packaging?

The question on monitoring requirements for packaging with no storage condition information was the first GDP-related question being published along with an answer in the Q&A Section of EMA's website.

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Import vs. Manufacturing: Any Differences in the EU?

What does it mean that, in the European Union (EU), all of the requirements for and obligations of Manufacturing Authorisation holders (MIAHs) also apply to importers?

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2D Matrix Codes: which countries are already connected to the European Hub?

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

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Product tracing - new FDA requirements

The FDA has published a draft guidance which is to standardise the data traceability of products. Find out how long traceability data for products need to be stored according to the new FDA guideline "Standardization of Data and Documentation Practices for Product Tracing".

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Fertility Drugs stolen in Italy

More than 16.000 packages of fertility drugs were stolen in Italy when a truck was hijacked.

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IMPs: Applicability of the GDP-Guidelines

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

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