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"Ambient", "Room Temperature", "Cold " - what is what?

What are the regulatory requirements behind "ambient", "room temperature" and "cold chain"? The answer to the meaning of different storage conditions is not that easy.

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New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

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Regulatory Expectations for Contract RPs

For some wholesalers, the concept of using an external Responsible Person might be useful. But there a few things which need to be considered.

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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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