Dutch Medicines Evaluation Board (CBG) announces public consultation regarding policy amendments
02 January 2019
On 27 November 2018, the CBG invited interested parties (notably patients, pharmacists and, healthcare professionals) to comment on its amendments of two amended policy documents, namely MEB 13 (on naming pharmaceutical products) and MEB 21 (on abbreviated indications on self-care packages) which were prompted by questions raised in the context of its (decisional) practice.
The most important amendments to MEB 13 are:
- The improvement of the assessment of a product name and the switch to a case-by-case analysis instead of automatic use of precedents.
- The improvement of the introductory explanation regarding fantasy names. The use of International Non-proprietary Names (INNs) for Pharmaceutical Substances of the WHO is prohibited to avoid confusion. The trademark can be part of the product name if the latter is a fantasy name, unless this results in an umbrella-brand (paraplumerk).
- The improvement of the explanation regarding naming generics containing different indications.
- The same generic name is allowed for different generic products if they are qualitatively and quantitatively equal (but not a copy), therapeutically equivalent and therefore exchangeable.
- The extension of the explanation regarding the reuse of fantasy names, which will be assessed on a case-by-case basis.
- The improvement of the explanation regarding the use of the abbreviated indication. Part of the indication may also be part of the product name if the abbreviated indication is set by MEB 21 and the pharmaceutical form is part of the product name.
- The amendment of the conditions in relation to the use of “Forte”, “Mitis”, “Extra” and “Extra Sterk”, where “pharmaceutical form” has been deleted.
The amendments of MEB 21 mainly concern the inclusion and removal of abbreviated indications and more generally the improvement of the conditions for these indications (notably for traditional herbal medicines).
CBG has set the deadline for comments at 7 January 2019.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2018 Issue (Thomson Reuters).