This November 2017 PharmDedict are proud to celebrate 10 years of service. In this period, we have supported over 100 renowned international and domestic companies. Our clients’ profile throughout the years covers a wide range of products: innovative pharmaceuticals, orphan drugs, radiopharmaceuticals, biological products, generic...
* This post has been marked as outdated and is available in our archive. Following the recent changes to the Bulgarian pricing & reimbursement regulatory framework, a new procedure was introduced and put into practice: the medicinal products included in the Bulgarian Positive Drug List (PDL)...
In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of...
A draft document containing the expected new fees concerning the pharmaceutical industry was published on the website of the Bulgarian Ministry of Health. The marketing authorisation holders (MAHs) are now expected to have the opportunity to pay reduced fees for grouped variations which is currently...
The new revised version 10.1 of the administrative information application form was published by the European Commission (Notice to applicants, medicinal products for human use, volume 2B, module 1.2). Marketing authorisation applicants shall use this form as from 3 June 2013, but may use it...