Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration

EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD. In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges …

Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?

The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …

A first glimpse of the UPD Public Portal

Although still under development, the UPD Public Portal offers a first glimpse of what will come: better access to medicinal product information for the public. Let’s have a look at what is on offer. The homepage mainly gives access to the substance and medicine index as well as the search functionality. As expected, under the …

Medicinal Product Line Outsourcing

Change creates opportunity, they say. Here’s one change that might benefit – if handled right – the medicine originator, the service provider, and foremost the patient by just moving the responsibilities of an entire medicinal product line into different hands. Part I – The Opportunity What opportunity am I talking about, as outsourcing itself is …

Are you listening to your animal patients?

We at Instem pride ourselves with mastering the technology to support the pharmaceutical, medical device and veterinary profession, bringing their life enhancing products to market faster. But that is not all. We also pride ourselves with being able to understand our clients’ patients, and this includes animals. The need for getting a better understanding of …

Union Product Database – EMA’s Agile Approach?

With the pressure mounting to implement the New Veterinary Regulations (NVR) which came into force 28th January 2022, releases of the Union Product Database (UPD) to be implemented under the NVR are getting more frequent. In true software development fashion, is the EMA using the Agile approach to get solutions out more frequently and much …

New Veterinary Regulations – Volume of Sales

Only days to go – The New Veterinary Regulation is coming into force on 28th January 2022. Time is running out for Marketing Authorisation Holders (MAHs), regulators and solution providers. The New Veterinary Regulation (NVR) is coming into force on 28/January/2022. Part of the NVR is the requirement for MAHs to provide information about the …

Structured Authoring – Streamlining Regulatory Submissions

It still surprises me that in an industry such as life sciences where quality, compliance and accuracy is of utmost importance, data that can be automatically handled is managed manually. Manual data management is prone to errors, is time consuming and is sometimes even a risky approach of dealing with information across different business functions. …

Veterinary Medicinal Products – VNeeS changes are coming

The EMA recently released a draft version 3.0 of the VNeesS specification for the provision of electronic submissions for veterinary medicinal products in the EU. Although more updates are expected, the EMA states that the basic folder structures of the draft specification are not subject to further changes. But what have Marketing Authorisation Holders (MAHs) …

Subsequent Recognition Procedure: A new kid on the block?

In Europe, Marketing Authorisation Applications (MAAs) can be submitted following different procedures. If Marketing Authorisation Holders (MAHs) desire access to all member of the European Economic Area (EEA) using a single procedure, the Centralised Procedure (CP) is the way to go. The EEA includes the members of the European Union plus Norway, Iceland and Lichtenstein. …