Blog
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 to the EU. It’s been also quite a while since a transition […]
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 supervised by the Minister responsible for agriculture, in order to obtain […]
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 of all marketing authorisations for both medicinal products for human use and veterinary medicinal products […]
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” – the applicant should use the dedicated CMDh […]
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” and … feel stumped. So many Modules, sections and requirements that it is overwhelming. In this case Experts of SciencePharma […]
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 long term use in the post-authorisation phase. Is it necessary to submit a PSUR for every medicinal product? The […]
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 used for the following purposes: The main objectives […]
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 submissions in the EU, Japan and recommended in US. It is worth noting that more and more […]
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 aspects Medical Device Regulation […]
OTC status – what is it all about?
09 November 2021
In general, medicinal products can be bought on prescription or over the counter (OTC). Many products introduced on prescription in the past, now are freely available without it. If you have in the portfolio prescription medicines, maybe it is time to consider whether they could be reclassified. OTC switch could be a time-consuming procedure, not in all cases possible, but worth considering if the safety data about the substance is favorable and […]
ATMP in the EU Guidelines – Regulatory Roadmap
13 October 2021
Advanced Therapy Medicinal Products (ATMPs) represent a fast-growing field of therapies consisting of cellular or genetic components that revolutionize the treatment approach of many previously incurable diseases. This field has attracted significant attention in recent years. Moreover, it is expected that the number of new developed and authorised ATMPs is going to increase significantly over the next few years as a results of the blossoming science in this area. […]
Pharmacovigilance Inspections – Key Points That You Should Know
14 September 2021
Pharmaceutical industry, and more particularly pharmacovigilance process, is strictly controlled field in terms of having many regulations and laws established by health authorities with rigid timelines to follow. To ensure that requirements for monitoring the drug safety are met, it is mandatory for Marketing Authorization Holders’ (MAH) pharmacovigilance systems (PV systems) to be audited by internal and external auditors and also by inspectors from national competent authorities. […]