Blog
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 […]
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 […]
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 […]
Brexit – is it still a concern for MA Holders?
17 May 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 Kingdom (UK) has formally left the European Union (EU). As a result, on 31 January 2020 UK became a third country […]
Cultivation of non-fibrous hemp legal in Poland!
09 May 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], [2]. The changes concern, among the others, the following areas: The regulation enables the cultivation of non-fibrous hemp, carried out in research institutes […]
Variations Regulation and implementation guidelines for type IA variations
20 April 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 to EU legislation should be notified to relevant Authority (or Authorities) as a variation. Provisions concerning the examination of variations to the terms […]
New template for responses in DC procedures
21 March 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 Decentralised Procedures for Marketing Authorisation Applications” has been updated to reflect the use of the new template. According to chapter “Presentation / content of the Response document” – […]
Preparing a medical part of registration dossier – how not to go mad?
09 March 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 to prepare medical part* of a dossier. So you open the most important book of medical writers “Notice to Applicants, volume 2B” […]
Periodic safety update report (PSUR) – essential facts that you should know
16 February 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 risk-benefit balance of a medicinal product. For the purposes of lifecycle benefit-risk management, it is crucial to continue evaluating the risks and benefits of a medicinal product in everyday practice and […]
Veterinary Medicinal Products Regulation (EU) 2019/6 of the European Parliament and of the Council
28 January 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, use and control of veterinary medicinal products. The definition of veterinary medicinal products As defined in Regulation 2019/6, veterinary medicinal products are every substance intended for animals and […]
The quality data of medicinal products in the registration dossier
19 January 2022
Module 3 is a part of the Common Technical Document (CTD) that contains all the quality data needed to the registration of a human medicinal product. The CTD is a special documentation format used for the submission of registration information of medicinal products to regulatory authorities. In 2003, it became required for all medicinal product […]
Medical Device Regulation – Regulatory aspects
23 November 2021
You’ve probably heard that after years of discussion, the European Medical Devices Regulation has been reviewed and was adopted on May 2017. Therefore the safety, quality and performance of medical devices destined for the EU market are now subject to new, more rigorous regulations that have entered into force. New regulation on medical devices – key […]