Changes in policy on nomenclature of medicinal products
The 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, i.e. 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 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 2 different terms on 1 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.
The MEB presented the proposed changes for the revision to the regular consultations with patient and consumer organisations, healthcare providers (Medical Practice Committee) and representatives from the pharmaceutical companies (Authorisation Contact Committee - CCR).
The new policy is effective immediately.