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What is EudraVigilance?

31.08.2022
EudraVigilance: basic information EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a system designed for reporting suspected adverse reactions to medicines, ...

A History of Pharmacovigilance

10.08.2022
What is pharmacovigilance and what led to its establishment? The second half of the twentieth century was marked by the dynamic development of medicine. Hand in hand with that, the average life ...

Risk Management Plan for EU and EAEU markets – comparison

20.07.2022
One of the documents that is needed to be prepared when registering medicinal product is Risk Management Plan (RMP). It is an obligatory document for each newly registered medicinal product. Its ...

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 ...