MEDICAL DEVICES – European Regulation 2017/745 – What happens to CE certificates obtained in compliance with the “old directive” 93/42/EEC?

The entry into force of the new regulation is now close. From 26 May 2020 it will no longer be…

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The management of the clinical trial in Italy after the Brexit

  On 29 March 2017 The United Kingdom notified its intention to withdraw from the European Union.  Thus, unless there…

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Optimising Orphan Drug Development in the EU

  The legislative framework on orphan medicinal products aims at stimulating research and development of medicinal products for rare diseases…

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Changes to the procedure for the request of access to the “AIFA 5% fund”

Changes have recently been introduced by AIFA concerning the procedure for the request of access to the so-called “AIFA 5%…

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REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION

After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) oN November 3rd, 2016, the “Rules” for registration…

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AIFA – SALES REPRESENTATIVE DATA TRANSMISSION

We are getting close to the deadline relevant to the annual transmission to AIFA of the sales representative data. Every year,…

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AIFA – PRICE INCREASE OF CLASS C MEDICINAL PRODUCTS SUBJECT TO MEDICAL PRESCRIPTION

AIFA has recently circulated on its website the communication about the price increase of Class C medicinal products subject to…

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MEDICAL DEVICES – NEW CLASSIFICATION REQUIREMENTS ACCORDING TO EUROPEAN REGULATION 2017/745

The European regulation 2017/745, that will become effective in May 2020, introduces several new requirements with an impact on several…

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IMPLEMENTATION OF A NEW VERSION OF THE OsSC PLATFORM FOR THE SUBMISSION OF CTAs AND AMENDMENTS IN ITALY

Changes in the management of Clinical Trial Applications and amendments have recently been introduced in Italy. A new version of…

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BREXIT- ARE YOU FULFILLING YOUR TASKS?

Further to the Brexit, all Union laws cease to apply to the United Kingdom from 30th March 2019. The “transition…

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