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Joanna Mrozinska

Hogan Lovells

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New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

European Union - May 16 2018 On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the...

Elisabethann Wright.

The HPRA published a MDRIVDR Guide for Distributors of Medical Devices

European Union - February 28 2018 The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides...

Fabien Roy.

European Commission released GMP Guidelines for Investigational Medicinal Products

European Union - January 22 2018 On 8 December 2017, detailed EU guidelines on good manufacturing practices ("GMP") for investigational medicinal products for human use were adopted...

Elisabethann Wright.