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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, ...

The quality data of medicinal products in the registration dossier

19.01.2022
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 ...

Medical Device Regulation – Regulatory aspects

23.11.2021
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 ...

OTC status – what is it all about?

09.11.2021
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 ...

ATMP in the EU Guidelines - Regulatory Roadmap

13.10.2021
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 ...

Pharmacovigilance Inspections - Key Points That You Should Know

14.09.2021
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 ...

How CMDh helps Marketing Authorisation Holders to facilitate regulatory procedures during the COVID-19 crisis?

17.08.2021
The SARS-CoV-2 virus pandemic has undoubtedly affected various areas of our lives, not only our private lives and interpersonal contacts, but it has also firmly affected the areas of lives ...

Registration of medicinal products – how to choose the right type of application?

02.07.2021
Anyone, who has even a little experience with pharmaceutical industry, probably knows that the development and registration of medicinal products is a complex, expensive and time-consuming ...