Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check

As stated in our previous blog, EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it clear that data quality [in PMS] is dependent on xEVMPD. PMS, the Product Management Service out of the EMA SPOR project builds on the data foundations of the Referential …

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 …

Cosmetic Claims Substantiation

The cosmetic industry needs to substantiate their claims as serious breaches of Regulation (EC) No 1223/2009 could be costly. In our last blog on Cosmetic Claims Management we discussed cosmetic claims and the impact of not being compliant to Regulation (EC) No 1223/2009. A Cosmetic Claims Management System might answer in real time many of …

Cosmetic Claims Management

Don’t take it lightly: Fines for serious breaches of Regulation (EC) No 1223/2009 on cosmetic products could be astronomical! Similar to the pharmaceutical industry, the cosmetic industry is regulated, one aspect being cosmetic claims. Where in the pharmaceutical industry an indication describes a medical condition that a medicinal product is used for, in a similar …