Changes in policy on nomenclature of medicinal products for Netherlands

19 October 2015

The Netherland’s Medicines Evaluation Board (MEB) has completely revised the policy document on the nomenclature of medicinal products for humans.

The most important changes are:

Distinction between “product name” and “nomenclature.” The MEB assesses the “nomenclature” of a product, ie, including strength, pharmaceutical form and any additions.
Mandatory listing of the salt form in the name is no longer required, unless the salt form is relevant to the product. Listing of the salt form on the packaging is still a requirement in accordance with Quality Review of Documents (QRD). In doing so, the MEB is meeting the objective to ensure that a product name is not unnecessarily long.
The policy document “Umbrella brands” no longer applies as the policy has been incorporated into this document. There was a lot overlap between the two documents.
The complete pharmaceutical form should be stated as stipulated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The use of two different terms on one package should be avoided as it could result in confusion, for example in the case of specific release profiles.
The inclusion of an abbreviated indication in the product name of OTC products, under certain conditions.
Policy for combination packages.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK