Name of the medicinal product

Proposed names should meet the Guideline on acceptability of names for human medicinal products processed through the centralised procedure (EMA/CHMP/287710/2014 – Rev. 6, 22 May 2014) implemented in to the Rules for granting marketing authorization for medicinal products (approved by the order No V-596 of the Health minister of the Republic of Lithuania on 10 July 2007).
 
Medicinal product names for the ongoing MRP/DCP procedures can be agreed during whole procedure as well as on validation phase or as alternative in the national phase, i.e. after Day 90/210. The medicinal product name for the National procedure must be agreed during the validation phase.
 
In the Product Characteristics Summary, Labelling and Package Leaflet, where the full name is required the name should be written in this way:

(Invented) name

*in certain cases (e.g. Herbal medicinal products, products with 4 or more active substances) strength can/should be avoided.

How to submit new name proposals outside the validation phase:

–        Maximum 4 names can be proposed for evaluation.

–        Additional information about the medicinal product should be included together with the new name proposals: procedure number, procedure type, information if procedure is ongoing or not, active substance, marketing authorisation holder, indications and contraindications, SmPC if available.

–        The proposals should be send to: [email protected]

Fill the proposal for the (invented) name.

The Agency will inform the Applicant about the name acceptability within 20 work days. If the Applicant does not agree with the Agency conclusion about the proposed names, the motivated contra arguments can be submitted. The Agency will evaluate the names again. The Applicant can submit new proposals at any time.
 
If the Applicant wants to change the name for already authorised medicinal product, the Variation need to be submitted.
  
For all other issues regarding names of the medicinal products please contact [email protected].