In addition to our letter N0401126314 dated on 30.10.2014 please be informed that electronic versions of medicine’s mock-ups, leaflet insert (instruction for use) and summary of product characteristics will be available on Centre official web site on the following dates:
- In case of medicine’s registration – within five days from the date of issuance of the order about state registration of the medicines in the RA (regardless of the procedure)
- In case of post-registration changes (when re-formulation of registration certificate is needed) - within five days from the date of issuance of the order about re-formulation of registration certificate of the medicine registered in the RA
- In case of post-registration changes (when re-formulation of registration certificate is not needed) - within two days from the date of outgoing letter given by Centre.
Also, in addition to the letter N0101123211 dated on 20.12.2011 about providing good quality of electronic database of the Centre, you are kindly asked to submit electronic versions of the documents listed below, that are subject to approval, in the following formats:
- Mock-ups – PDF high quality (600dpi Press Quality)
- Leaflet insert (instruction for use) - PDF or MS Word, in case you submit typographic version - PDF high quality (600dpi Press Quality)
- Summary of product characteristics - PDF or MS Word.
Director Hakob Topchyan