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Variation - how to successfully update your dossier

13.06.2022
Have you been granted the Marketing Authorisation (MA) for your medicinal product? Are you about to release it into the market? That is for sure very positive information! Do you think it is over ...

Borderline products: drug or device? Line of demarcation drawn by new MDCG guidance

31.05.2022
Medical device regulation 2017/745 (MDR) entered into full application on May 26, 2021, but still a lot of uncertainty is associated with its implementation. So far, over 70 guidance documents ...

Clinical Evaluation Report - grounds for clinical evaluation of medical devices

25.05.2022
Clinical Evaluation Report (CER) constitutes a significant part of technical documentation (TD) that summarizes and draws conclusions on the clinical evaluation of the medical device (MD). The ...

Brexit - is it still a concern for MA Holders?

17.05.2022
Time is passing very fast, relentlessly, and while it may seem that Brexit happened only yesterday, it in fact has been a long time since the British voters passed the 2016 referendum and United ...

Cultivation of non-fibrous hemp legal in Poland!

09.05.2022
The changes in act on counteracting drug addiction came into effect. On April 6, 2022, the Sejm of the Republic of Poland announced acts amending the act on counteracting drug addiction [1], ...

Variations Regulation and implementation guidelines for type IA variations

20.04.2022
Are you planning to amend your product dossier and wondering how you should do this? Note that any changes to the terms of a marketing authorisation (MA) for medicinal products authorised pursuant ...

New template for responses in DC procedures

21.03.2022
The CMDh has approved a new template for applicants to provide their responses during DC procedures The CMDh guidance document “Applicant's Response document in Mutual Recognition and ...

Preparing a medical part of registration dossier – how not to go mad?

09.03.2022
Introducing a medicinal product on the market is a challenge. All these tests, exhausting hours in the laboratory, demanding studies, and when finally the success is on the horizon, it comes a day ...

Periodic safety update report (PSUR) – essential facts that you should know

16.02.2022
What is a Periodic safety update report (PSUR)? Periodic safety update report (PSUR) is a pharmacovigilance document intended to provide a critical, comprehensive evaluation of the ...

Veterinary Medicinal Products Regulation (EU) 2019/6 of the European Parliament and of the Council

28.01.2022
On 28 January 2022, ‘Regulation (EU) 2019/6 of the European Parliament and of the Council, repealing Directive 2001/82/EU’, comes into force. It introduces rules for the authorisation, ...