Blog
Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland
01 March 2023
As soon as the MA has been granted for the medicinal product, the Marketing Authorisation Holder (MAH) is responsible for the product’s quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the MAH has different obligations, which must be kept […]
Clinical trials – where to conduct them?
01 February 2023
Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves where to test the developed medicinal product. However, there is no easy and straightforward answer as there are no formal limits in choosing the country. In this article we would like to bring the topic of country selection for clinical trials and present some benefits of certain countries – […]
Skin products – What’s new in the ICH Q3D Guideline For Elemental Impurities?
18 January 2023
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA). It was published on 2 May 2022 and came into force on 24 September 2022. The document introduces limits for elemental impurities present […]
Pharmacovigilance system provider
06 December 2022
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is essential to monitor post-authorisation safety of medicines to gather all safety data from a large number of various patients with numerous conditions and concomitant therapies using the drug for a long period of time. Therefore, each marketing authorisation holder (MAH) is legally obligated to operate […]
TOP 10 challenges in Market Access of ATMPs
25 November 2022
The Market Access (MA) topic is fascinating in itself, but like any topic, it will be more easily remembered and assimilated if it is described in a non-standard way. Instead of using official definitions regarding Market Access, let’s go through the subject of MA on the example of Advanced Therapy Medicinal Products (ATMPs). Quite challenging? Probably yes, but like they say: where there’s a will, there’s a way. Market Access […]
Unstoppable changes in pharmacovigilance of veterinary medicinal products
04 November 2022
Are you ready for the new regulations? At the beginning of year 2022 Veterinary Regulation 2019/06 has come into force, introducing innovative approach to safety surveillance of veterinary medicinal products. Marketing Authorisation Holders (MAHs) will now face new challenges with regard to fulfilling legal obligations and maintaining their pharmacovigilance system up-to-date. Below provided summary gives an overview on the upcoming changes and […]
What is EudraVigilance?
31 August 2022
EudraVigilance: basic information EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a system designed for reporting suspected adverse reactions to medicines, otherwise known as adverse drug reactions (ADRs). It has been in operation since December 2001. The European Medicines Agency (EMA) is responsible for developing, maintaining and coordinating the database. EudraVigilance supports the safe and effective use of medicines by way of: the electronic […]
A History of Pharmacovigilance
10 August 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 expectancy increased and there was a significant drop in infant mortality. Moreover, humanity emerged victorious in the battle with numerous diseases which had been deemed incurable in previous decades. Of course, this development was […]
Risk Management Plan for EU and EAEU markets – comparison
20 July 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 aim is, on the one hand, to characterize the safety profile of a given drug and, on the other hand, to broaden the knowledge of potential risks for the patient and to plan measures to minimize these risks. For more information […]
Variation – how to successfully update your dossier
13 June 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 and from now on, nothing more has to be done? Unfortunately not. During your product’s life cycle you will surely deal with many improvements and face multiple post-approval variations […]
Borderline products: drug or device? Line of demarcation drawn by new MDCG guidance
31 May 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 have been published to assist stakeholders in applying MDR. Recently, a new Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022-05) has been issued by the European […]
Clinical Evaluation Report – grounds for clinical evaluation of medical devices
25 May 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 analysis and critical appraisal of clinical and non-clinical data regarding the device in question aims to demonstrate that the MD achieves its intended purpose with acceptable risk for users. Clinical Evaluation Reports are required for […]